<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03227224</url>
  </required_header>
  <id_info>
    <org_study_id>CR108281</org_study_id>
    <secondary_id>42847922MDD2001</secondary_id>
    <secondary_id>2015-005282-22</secondary_id>
    <nct_id>NCT03227224</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Efficacy and Safety of JNJ-42847922 as Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder Who Have Responded Inadequately to Antidepressant Therapy</brief_title>
  <official_title>A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Adaptive Dose-Finding Study to Evaluate the Efficacy and Safety of JNJ-42847922 as Adjunctive Therapy to Antidepressants in Adult Subjects With Major Depressive Disorder Who Have Responded Inadequately to Antidepressant Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Research &amp; Development, LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the dose-response relationship of 2 doses of&#xD;
      JNJ-42847922 before interim analysis, and potentially 3 doses based on interim analysis&#xD;
      results, compared to placebo as adjunctive therapy to an antidepressant drug in improving&#xD;
      depressive symptoms in participants with Major Depressive Disorder (MDD) who have had an&#xD;
      inadequate response to current antidepressant therapy with a selective serotonin reuptake&#xD;
      inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI); and to assess the&#xD;
      safety and tolerability of JNJ-42847922 compared to placebo as adjunctive therapy to an&#xD;
      antidepressant in participants with MDD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will investigate the antidepressant effects of a range of doses of JNJ-42847922&#xD;
      (seltorexant) (versus placebo), as adjunctive treatment to antidepressant drugs for treatment&#xD;
      of MDD, and will assess the safety and tolerability of JNJ-42847922. The study will be&#xD;
      conducted in 3 phases: a screening phase (up to 4 weeks), a double-blind treatment phase (6&#xD;
      weeks), and a post-treatment follow-up phase (2 weeks). Efficacy, safety, pharmacokinetic,&#xD;
      and biomarker evaluations will be performed in the study at defined timepoints. The duration&#xD;
      of the study will be up to approximately 12 weeks (84 days).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 16, 2017</start_date>
  <completion_date type="Actual">January 19, 2019</completion_date>
  <primary_completion_date type="Actual">January 12, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score</measure>
    <time_frame>Baseline to Week 6</time_frame>
    <description>MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score range of 0-60 which is calculated by adding the scores of all 10 items. Higher scores represent a more severe condition.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability</measure>
    <time_frame>Up to Week 8</time_frame>
    <description>An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between the initial administration of study drug and 2 days after the last administration of study drug.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Clinically Significant Laboratory Abnormalities</measure>
    <time_frame>Up to Week 8</time_frame>
    <description>Percentage of participants with clinically significant laboratory abnormalities were reported which included Gamma-glutamyl transferase (GGT), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Creatine Kinase (CK), Lactate Dehydrogenase (LDH), Albumin , bicarbonate, bilirubin, calcium, chloride, cholesterol, creatinine, direct bilirubin, glucose, high density lipoprotein (HDL) cholesterol, hemoglobin A1C, low density lipoprotein (LDL) cholesterol, phosphate, potassium, protein, sodium, triglycerides, urate, and urea nitrogen.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) at Day 8</measure>
    <time_frame>Baseline and Day 8</time_frame>
    <description>Change from baseline in vital signs (SBP and DBP) at Day 8 was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Vital Signs (SBP and DBP) at Day 22</measure>
    <time_frame>Baseline and Day 22</time_frame>
    <description>Change from baseline in vital signs (SBP and DBP) at Day 22 was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Vital Signs (SBP and DBP) at Day 42</measure>
    <time_frame>Baseline and Day 42</time_frame>
    <description>Change from baseline in vital signs (SBP and DBP) at Day 42 was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Vital Signs (SBP and DBP) at Endpoint (Week 6)</measure>
    <time_frame>Baseline and Endpoint (Week 6)</time_frame>
    <description>Change from baseline in vital signs (SBP and DBP) at endpoint was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Vital Sign (Pulse Rate [PR]) at Day 8</measure>
    <time_frame>Baseline and Day 8</time_frame>
    <description>Change from baseline in vital sign (PR) at Day 8 was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Vital Sign (PR) at Day 22</measure>
    <time_frame>Baseline and Day 22</time_frame>
    <description>Change from baseline in vital sign (PR) at Day 22 was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Vital Sign (PR) at Day 42</measure>
    <time_frame>Baseline and Day 42</time_frame>
    <description>Change from baseline in vital sign (PR) at Day 42 was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Vital Sign (PR) at Endpoint (Week 6)</measure>
    <time_frame>Baseline and Endpoint (Week 6)</time_frame>
    <description>Change from baseline in vital sign (PR) at endpoint (Week 6) was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Vital Sign (Temperature) at Day 8</measure>
    <time_frame>Baseline and Day 8</time_frame>
    <description>Change from baseline in vital Sign (temperature) at Day 8 was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Vital Sign (Temperature) at Day 22</measure>
    <time_frame>Baseline and Day 22</time_frame>
    <description>Change from baseline in vital Sign (temperature) at Day 22 was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Vital Sign (Temperature) at Day 42</measure>
    <time_frame>Baseline and Day 42</time_frame>
    <description>Change from baseline in vital Sign (temperature) at Day 42 was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Vital Sign (Temperature) at Endpoint (Week 6)</measure>
    <time_frame>Baseline and Endpoint (Week 6)</time_frame>
    <description>Change from baseline in vital Sign (temperature) at endpoint (Week 6) was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Physical Examination (Waist Circumference) at Day 42</measure>
    <time_frame>Baseline and Day 42</time_frame>
    <description>Change from baseline in physical examination (waist circumference) was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Physical Examination (Body Weight) at Day 42</measure>
    <time_frame>Baseline and Day 42</time_frame>
    <description>Change from baseline in physical examination (body weight) was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Physical Examination (Body Mass Index [BMI]) at Day 42</measure>
    <time_frame>Baseline and Day 42</time_frame>
    <description>Change from baseline in physical examination (BMI) was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values Outside Pre-defined Limits</measure>
    <time_frame>Up to Week 6</time_frame>
    <description>Percentage of participants with treatment-emergent abnormal ECG values (Heart rate less than or equal to [&lt;=] 50 or greater than or equal to [&gt;=] 100 beats per minute [bpm], PR interval &lt;=120 or &gt;=200 milliseconds [msec], QRS interval &lt;=60 or &gt;=120 msec, and QT interval &lt;=200 or &gt;=500 msec) outside pre-defined limits were reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Most Severe Post-baseline Potentially Suicide-Related Category Using Columbia Suicide Severity Rating Scale (C-SSRS)</measure>
    <time_frame>Up to Week 8</time_frame>
    <description>C-SSRS is a clinician-rated instrument that reports severity of both suicidal ideation and behavior. Suicidal ideation was classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods [not plan] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. Minimum total score 0, maximum total score 5; higher total scores indicate more suicidal ideation and/or suicidal behavior. If no events qualify for score of 1 to 10, score of 0 was assigned (0= &quot;no event that can be assessed on the basis of C-SSRS&quot;). Higher scores indicate greater severity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Sexual Functioning as Measured by Arizona Sexual Experiences Scale (ASEX) Score at Day 42</measure>
    <time_frame>Baseline and Day 42</time_frame>
    <description>Effect on sexual functioning was assessed using the ASEX score. The ASEX is a five-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Each of the 5 items is rated on a 6-point scale, ranging from 1 to 6. The 5 items are summed to create a total score, ranging from 5 to 30, with the higher scores indicating more sexual dysfunction.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physician Withdrawal Checklist-20 (PWC-20) Total Score at Day 43</measure>
    <time_frame>Day 43</time_frame>
    <description>Intensity of discontinuation symptoms was assessed (for example: underlying depression; anxiety-nervousness; dysphoric mood/depression; difficulty concentrating; weakness; fatigue-lethargy-lack of energy; irritability), using the Physician Withdrawal Checklist (PWC-20) administered by a trained clinician/rater. Symptoms are rated on a scale 0 (No symptom present) and 3 (severe symptoms). Total scores range from 0 to 24 calculated by adding the scores of following 8 items: Nausea-Vomiting, Diarrhea, Poor Coordination, Diaphoresis, Tremor-Tremulousness, Dizziness-Lightheadedness, Increased Acuity Sound Smell Touch, Paresthesias. Higher scores indicating more severe symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physician Withdrawal Checklist-20 (PWC-20) Total Score From Day 49 to Day 56</measure>
    <time_frame>Day 49 to Day 56</time_frame>
    <description>Intensity of discontinuation symptoms was assessed (for example: underlying depression; anxiety-nervousness; dysphoric mood/depression; difficulty concentrating; weakness; fatigue-lethargy-lack of energy; irritability), using the Physician Withdrawal Checklist (PWC-20) administered by a trained clinician/rater. Symptoms are rated on a scale 0 (No symptom present) and 3 (severe symptoms). Total scores range from 0 to 24 calculated by adding the scores of following 8 items: Nausea-Vomiting, Diarrhea, Poor Coordination, Diaphoresis, Tremor-Tremulousness, Dizziness-Lightheadedness, Increased Acuity Sound Smell Touch, Paresthesias. Higher scores indicating more severe symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the MADRS Total Score by Baseline Insomnia Severity Index (ISI) Score at Day 42</measure>
    <time_frame>Baseline and Day 42</time_frame>
    <description>MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score range of 0-60 which is calculated by adding the scores of all 10 items. Higher scores represent a more severe condition. The ISI has 7 questions, each rated on a 5-point Likert scale ranging from 0 to 4. The total score is calculated as the sum of the 7 items ranging from 0 to 28. Higher scores represent a more severe condition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in ISI Total Score at DB Endpoint (Up to Week 6)</measure>
    <time_frame>Baseline and DB Endpoint (Up to Week 6)</time_frame>
    <description>The ISI is a commonly used, 7-item psychometrically validated measure used to rate insomnia. Each item is scored 0 (no problem) to 4 (very big problem) with total between 0-28 which is calculated by adding the scores of all 7 items (absence of insomnia [0-7]; sub-threshold insomnia [8-14]; moderate insomnia [15-21]; and severe insomnia [22-28]). The change in ISI total score from baseline at DB endpoint was evaluated. Negative change in score indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Response on Depressive Symptoms Scale Based on MADRS Total Score</measure>
    <time_frame>Day 42</time_frame>
    <description>Responders are defined as participants with a &gt;=50 percent (%) improvement in the MADRS total score from baseline to a given timepoint. MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score range of 0-60 which is calculated by adding the scores of all 10 items. Higher scores represent a more severe condition. Participants with missing values at a given time point were imputed as non-responders.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Remission of Depressive Symptoms Based on MADRS Total Score</measure>
    <time_frame>Day 42</time_frame>
    <description>Participants with a MADRS total score of less than or equal to (&lt;=) 8, &lt;=10, and &lt;=12 at a given time point were considered as remitters. MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score range of 0-60 which is calculated by adding the scores of all 10 items. Higher scores represent a more severe condition. Participants with missing values at a given time point were imputed as non-responders.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Structured Interview Guide for the Hamilton Anxiety Rating Scale (HAM-A) Total Score at Day 42</measure>
    <time_frame>Baseline and Day 42</time_frame>
    <description>HAM-A is a 14-item scale designed to measure anxiety in individuals. Each question reflects a symptom of anxiety and physical as well as mental symptoms are represented. Each of the 14-items in the scale is scored on a 5-point scale, ranging from 0 (a complete lack of that symptom) to 4 (a very severe show of anxiety with that symptom). The total score ranges from 0 to 56 which is calculated by adding the scores of all 14 items, where 0-13 indicates normal range, 14-17 indicates mild severity, 18 -24: mild to moderate severity, 25 -30: moderate to severe, and &gt;=31: severe. Higher score indicates worsening. Negative change in score indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Response on Anxiety Symptoms Scale Based on HAM-A Total Score</measure>
    <time_frame>Day 42</time_frame>
    <description>Participants with a &gt;=50 percent improvement in the HAM-A total score from baseline at a given timepoint were considered as responders. HAM-A is a 14-item scale designed to measure anxiety in individuals. Each question reflects a symptom of anxiety and physical as well as mental symptoms are represented. Each of the 14-items in the scale is scored on a 5-point scale, ranging from 0 (a complete lack of that symptom) to 4 (a very severe show of anxiety with that symptom). The total score ranges from 0 to 56 which is calculated by adding the scores of all 14 items, where 0-13 indicates normal range, 14-17 indicates mild severity, 18 -24: mild to moderate severity, 25 -30: moderate to severe, and &gt;=31: severe. Higher score indicates worsening. Participants with missing values at a given time point were imputed as non-responders.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at DB Endpoint (Up to Week 6)</measure>
    <time_frame>Baseline and DB Endpoint (Up to Week 6)</time_frame>
    <description>The CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes into account all available information, including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S is a 7-point global assessment scale that measures the clinician's impression of the severity of illness exhibited by a participant, rating according to: 1=normal (not at all ill); 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7=among the most extremely ill participants. Higher scores indicate worsening. Negative change in score indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Sheehan Disability Scale (SDS) Score at Day 42</measure>
    <time_frame>Baseline and Day 42</time_frame>
    <description>The SDS is a 5-item questionnaire which has been widely used and accepted for assessment of functional impairment and associated disability. The first 3 items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a 0-10 rating scale. The scores for the first 3 items are summed to create a total score of 0-30, where a higher score indicates greater impairment. It also has 1 item on days lost from school or work and 1 item on days when underproductive. Negative change in score indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the MADRS Total Score at Day 42 in Participants With Major Depressive Disorder (MDD) With Anxious Distress Versus Participants With MDD Without Anxious Distress</measure>
    <time_frame>Baseline and Day 42</time_frame>
    <description>MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score range of 0-60 which is calculated by adding the scores of all 10 items. Higher scores represent a more severe condition. Negative change in score indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Salivary Cortisol Levels, Measured Upon Awakening at Days 8, 22 and 42</measure>
    <time_frame>Baseline, Days 8, 22 and 42</time_frame>
    <description>Exposure on the hypothalamic-pituitary-adrenal (HPA) axis in participants with MDD was evaluated by assessing change in salivary cortisol levels.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Concentrations of Seltorexant and Its Metabolites (M12 and M16)</measure>
    <time_frame>Day 1: Between 0.25 hours (h) to 1.5 hour, 2 to 4 hours, and 6 to 8 hours post-dose; Day 8 (morning): 6 to 12 hours post evening dose of Day 7</time_frame>
    <description>Plasma concentrations of Seltorexant and its metabolites (M12 and M16) over time were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Depressive Symptoms Using the Patient Health Questionnaire 9-Item (PHQ-9) at DB Endpoint (Up to Week 6)</measure>
    <time_frame>Baseline and DB Endpoint (Up to Week 6)</time_frame>
    <description>The PHQ-9 is a 9-item, Patient Reported Outcome (PRO) measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) major depressive disorder (MDD) criteria. Each item is rated on a 4 point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participants item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 is categorized as follows: None-minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19) and Severe (20-27).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Anhedonia Using the Snaith-Hamilton Pleasure Scale (SHAPS) Score at DB Endpoint (Up to Week 6)</measure>
    <time_frame>Baseline and DB Endpoint (Up to Week 6)</time_frame>
    <description>The SHAPS is a 14-item, self-report instrument to assess hedonic capacity in adults with MDD. Each of the items has a set of 4 response categories-Definitely Agree (=1), Agree (=2), Disagree (=3), and Definitely Disagree (=4). A total score is created with either of the Disagree responses receiving a score of 1 and either of the Agree responses receiving a score of 0. The participants item responses are summed to provide a total score ranging from 0 to 14. A higher total SHAPS score indicates higher levels of current anhedonia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form at DB Endpoint (Up to Week 6)</measure>
    <time_frame>Baseline and DB Endpoint (Up to Week 6)</time_frame>
    <description>The PROMIS-SD Short Form subscale consists of a static 8 item questionnaire. It assesses the concepts of sleep initiation (2 items), quality of sleep (3 items), early morning feelings (2 items) and worrying about sleep (1 item). Responses to each of the 8 items range from 1 to 5, and the range of possible summed raw scores is 8 to 40. Higher scores on the PROMIS-SD indicate more of the concept measured (disturbed sleep). Negative change in score indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fatigue Using the Patient Reported Outcome Measurement Information System-Fatigue (PROMIS-F) Short Form Subscale Score at DB Endpoint (Up to Week 6)</measure>
    <time_frame>Baseline and DB Endpoint (Up to Week 6)</time_frame>
    <description>The PROMIS-Fatigue Short Form subscale consists of a static 8 item questionnaire. It assesses a range of symptoms from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Ratings are done on a 5-item Likert scale ranging from 0 (not at all) to 5 (very much) or 0 (never) to 5(always) depending upon the question answered. Higher scores on the PROMIS-F indicate more of the concept measured (fatigue). Negative change in score indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Severity of Depression Using the Patient Global Impression-Severity (PGI-S) Score at DB Endpoint (Up to Week 6)</measure>
    <time_frame>Baseline and DB Endpoint (Up to Week 6)</time_frame>
    <description>The PGI-S is a self-report scale to measure severity of illness (1=none, 2=mild, 3=moderate, 4=severe). Higher score indicates more illness severity. Negative change in score indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Heath State Index Total Score at DB Endpoint (Up to Week 6)</measure>
    <time_frame>Baseline and DB Endpoint (Up to Week 6)</time_frame>
    <description>EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses to 5 EQ-5D-5L dimensions were scored using a utility-weighted algorithm to derive an EQ-5D-5L health status index score between 0 (death) to 100 (full health).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in EQ-5D-5L Visual Analog Scale (VAS) Total Score at Endpoint (Up to Week 6)</measure>
    <time_frame>Baseline and Endpoint (up to Week 6)</time_frame>
    <description>The EQ-5D-5L is a standardized instrument for use as a measure of health outcome, primarily designed for self-completion by respondents. It consists of the EQ-5D-5L descriptive system and the EQ visual analogue scale (EQ-VAS). EQ-5D-5L (describing and valuing health-related quality of life) descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the participant's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. Higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. EQ-VAS self-rating records respondent's own assessment of his/her overall health status at time of completion, on scale of 0 (worst health you can imagine) to 100 (best health you can imagine).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Work Productivity and Limitations Using the Work Limitations Questionnaire (WLQ) Short Form Score at DB Endpoint (Up to Week 6)</measure>
    <time_frame>Baseline and DB Endpoint (Up to Week 6)</time_frame>
    <description>The WLQ is to assess the on-the-job impact of chronic health problems and/or treatment (&quot;work limitations&quot;) in adults. It is a 8-item questionnaire self-report rating scale developed to measure the on-the-job impact of chronic health problems and/or treatment (&quot;work limitations&quot;). It comprises five dimensions of limitations: handling time, physical, mental-interpersonal, productivity loss and output demands. Participants respond to each item with options ranging from 'Almost all of the time' to 'none of the time', or 'Does not apply to my job'. Each dimension of limitations have a scale score ranging from 0 to 100 with lower score indicating low level of work limitations.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">287</enrollment>
  <condition>Depressive Disorder, Major</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive 2 placebo capsules matching JNJ-42847922 once daily orally from Day 1 to Day 41 (Week 6).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>JNJ-42847922</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive 2 capsules of JNJ-42847922 once daily orally from Day 1 to Day 41 (Week 6).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants will receive 2 placebo capsules matching JNJ-42847922 once daily orally from Day 1 to Day 41 (Week 6).</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-42847922</intervention_name>
    <description>Participants will receive 2 capsules of JNJ-42847922 once daily orally from Day 1 to Day 41 (Week 6).</description>
    <arm_group_label>JNJ-42847922</arm_group_label>
    <other_name>MIN-202;</other_name>
    <other_name>Seltorexant</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men or women of non-childbearing potential (WONCBP), aged 18 to 70 years (inclusive).&#xD;
             A WONCBP is defined as: a).Postmenopausal: A postmenopausal state is defined as no&#xD;
             menses for 12 months without an alternative medical cause. b). Permanently sterile:&#xD;
             Permanent sterilization methods include hysterectomy, bilateral salpingectomy,&#xD;
             bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy. c). If&#xD;
             reproductive status is questionable, additional evaluation should be considered&#xD;
&#xD;
          -  Meet Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5)&#xD;
             diagnostic criteria for major depressive disorder (MDD), without psychotic features,&#xD;
             based upon clinical assessment and confirmed by the Structured Clinical Interview for&#xD;
             DSM-5 Axis I Disorders- Clinical Trials Version (SCID-CT). In addition their major&#xD;
             depressive episode must be deemed &quot;valid&quot; using the SCID Screening Questionnaire (SSQ)&#xD;
             interview administered by remote, independent raters. The length of the current&#xD;
             depressive episode must be less than or equal to (&lt;=) 18 months&#xD;
&#xD;
          -  Have had an inadequate response to at least 1 but no more than 3 antidepressants,&#xD;
             administered at an adequate dose and duration in the current episode of depression, as&#xD;
             measured by the Massachusetts General Hospital-Antidepressant Treatment Response&#xD;
             Questionnaire (MGH-ATRQ). An inadequate response is defined as less than (&lt;)50 percent&#xD;
             (%) reduction in depressive symptom severity, as assessed by the MGH-ATRQ. An adequate&#xD;
             trial is defined as an antidepressant treatment for at least 4 weeks at or above the&#xD;
             minimum therapeutic dose specified in the MGH-ATRQ, for any particular antidepressant.&#xD;
             The inadequate response must include the participant's current antidepressant&#xD;
             treatment&#xD;
&#xD;
          -  Participants receiving monotherapy treatment for depressive symptoms with one of the&#xD;
             following selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake&#xD;
             inhibitor (SSRI/SNRI) antidepressants, in any formulation: citalopram, duloxetine,&#xD;
             escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine,&#xD;
             sertraline, venlafaxine, desvenlafaxine, vilazodone, or vortioxetine at a stable dose&#xD;
             (at or above the minimum therapeutic dose level) for at least 4 weeks, and for no&#xD;
             greater than 12 months, at screening. Modification of an effective preexisting therapy&#xD;
             should not be made for the explicit purpose of entering a subject into the study&#xD;
&#xD;
          -  Have a Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than or&#xD;
             equal to (&gt;=)25 (performed by independent, centralized remote raters) at screening and&#xD;
             must not demonstrate a clinically significant improvement (that is, an improvement of&#xD;
             greater than [&gt;]20% on their MADRS total score) from the screening to baseline visit&#xD;
&#xD;
          -  Must be otherwise healthy on the basis of physical examination, medical history, vital&#xD;
             signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at&#xD;
             screening. If the results of the clinical laboratory tests are outside the normal&#xD;
             reference ranges, the participant could be included only if the investigator judges&#xD;
             the abnormalities or deviations from normal to be not clinically significant or to be&#xD;
             appropriate and reasonable for the population under study. This determination must be&#xD;
             recorded in the participant's source documents and initialed by the investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has a history of, or current signs and symptoms of, severe renal insufficiency&#xD;
             (creatinine clearance &lt;30 milliliter per minute [mL/min]); moderate to severe hepatic&#xD;
             insufficiency (Child-Pugh Score 7-9), significant or unstable cardiovascular,&#xD;
             respiratory, gastrointestinal, neurologic (including narcolepsy), hematologic,&#xD;
             rheumatologic, immunologic or endocrine disorders (including uncontrolled hypo- or&#xD;
             hyperthyroidism or diabetes, or insulin-dependent diabetes mellitus). Participants&#xD;
             with non-insulin dependent diabetes mellitus who are well-controlled (hemoglobin A1C&#xD;
             [HbA1C] &lt;=7.5% and fasting glucose &lt;126 milligram per deciliter [mg/dL] at screening)&#xD;
             could be eligible to participate if otherwise medically healthy, and if on a stable&#xD;
             regimen of glucose-lowering medications for at least 2 months prior to screening&#xD;
&#xD;
          -  Has signs and symptoms of Cushing's Disease, Addison's Disease, primary amenorrhea, or&#xD;
             other evidence of significant medical disorders of the hypothalamic-pituitary-adrenal&#xD;
             (HPA) axis&#xD;
&#xD;
          -  Has a history of lack of response to 3 or more adequate antidepressant treatments, as&#xD;
             indicated by no or minimal (&lt;= 25% improvement in symptoms) when treated with an&#xD;
             antidepressant of adequate dose (per MGH-ATRQ) and duration (at least 4 weeks)&#xD;
&#xD;
          -  Has history or current diagnosis of a psychotic disorder, bipolar disorder, mental&#xD;
             retardation, autism spectrum disorder, or borderline personality disorder, somatoform&#xD;
             disorders, chronic fatigue syndrome or fibromyalgia&#xD;
&#xD;
          -  Has any significant primary sleep disorder, including but not limited to obstructive&#xD;
             sleep apnea, restless leg syndrome, or parasomnias&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Research &amp; Development, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Research &amp; Development, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>California Pharmaceutical Research Institute, Inc.</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Catalina Research Institute</name>
      <address>
        <city>Chino</city>
        <state>California</state>
        <zip>91710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synergy Clinical Research Center Of Escondido</name>
      <address>
        <city>Lemon Grove</city>
        <state>California</state>
        <zip>91945</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asclepes Research</name>
      <address>
        <city>Panorama City</city>
        <state>California</state>
        <zip>91402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sharp Mesa Vista Hospital</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SF-Care, Inc</name>
      <address>
        <city>San Rafael</city>
        <state>California</state>
        <zip>94901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Collaborative NeuroScience Network</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elite Clinical Trials</name>
      <address>
        <city>Wildomar</city>
        <state>California</state>
        <zip>92595-7007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarkis Clinical Trials</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Velocity Clinical Research, Hallandale Beach</name>
      <address>
        <city>Hallandale Beach</city>
        <state>Florida</state>
        <zip>33009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical NeuroScience Solutions, Inc</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Innovative Clinical Research, Inc.</name>
      <address>
        <city>Lauderhill</city>
        <state>Florida</state>
        <zip>33319</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galiz Research</name>
      <address>
        <city>Miami Springs</city>
        <state>Florida</state>
        <zip>33166</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qps-Mra, Llc</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Behavioral Clinical Research , Inc</name>
      <address>
        <city>North Miami</city>
        <state>Florida</state>
        <zip>33162</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical NeuroScience Solutions, Inc</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Compass Research LLC</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research, Inc.</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30328</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Center for Medical Research</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30331</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NeuroTrials Research, Inc.</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chicago Research Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60634</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Lakes Clinical Trials</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60640</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Joliet Center for Clinical Research</name>
      <address>
        <city>Joliet</city>
        <state>Illinois</state>
        <zip>60435</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinilabs</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10019</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Richmond Behavioral Associates</name>
      <address>
        <city>Staten Island</city>
        <state>New York</state>
        <zip>10312</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of America</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest Baptist Medical Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neuro-Behavioral Clinical Research</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <zip>44708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwest Clinical Research Center</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45417</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Suburban Research Associates</name>
      <address>
        <city>Media</city>
        <state>Pennsylvania</state>
        <zip>19063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Family Psychiatry of The Woodlands</name>
      <address>
        <city>The Woodlands</city>
        <state>Texas</state>
        <zip>77381</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Core Clinical Research</name>
      <address>
        <city>Everett</city>
        <state>Washington</state>
        <zip>98201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mental Health Center Prof. Dr. Ivan Temkov</name>
      <address>
        <city>Burgas</city>
        <zip>8000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Psychiatric Hospital Kardzhali</name>
      <address>
        <city>Kardzhali</city>
        <zip>6600</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Psychiatric Hospital - Lovech</name>
      <address>
        <city>Lovech</city>
        <zip>5500</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT 'Dr. Georgi Stranski', EAD</name>
      <address>
        <city>Pleven</city>
        <zip>5800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MC 'Hipokrat - N', EOOD</name>
      <address>
        <city>Plovdiv</city>
        <zip>4002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mental Health Center - Rousse</name>
      <address>
        <city>Rousse</city>
        <zip>7003</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHC - Sofia, EOOD</name>
      <address>
        <city>Sofia</city>
        <zip>1202</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Multiprofile Hospital for Active Treatment - UMHAT Alexandrovska EAD</name>
      <address>
        <city>Sofia</city>
        <zip>1431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center 'Doverie'</name>
      <address>
        <city>Sofia</city>
        <zip>1632</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center Intermedica, OOD</name>
      <address>
        <city>Sofia</city>
        <zip>1680</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT-Targovishte, AD</name>
      <address>
        <city>Targovishte</city>
        <zip>7700</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Psychiatric Hospital - Tzarev Brod</name>
      <address>
        <city>Tzarev Brod</city>
        <zip>9747</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diagnostic Consulting Center Mladost - M Varna</name>
      <address>
        <city>Varna</city>
        <zip>9020</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mental Health Center - Veliko Tarnovo EOOD</name>
      <address>
        <city>Veliko Tarnovo</city>
        <zip>5000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mederon Oy</name>
      <address>
        <city>Helsinki</city>
        <zip>00100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Savon Psykiatripalvelu</name>
      <address>
        <city>Kuopio</city>
        <zip>70110</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oulu Mentalcare Oy</name>
      <address>
        <city>Oulu</city>
        <zip>90100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Satakunnan Psykiatripalvelu</name>
      <address>
        <city>Rauma</city>
        <zip>26100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Clermont-Ferrand - Hopital Gabriel Montpied</name>
      <address>
        <city>Clermont Ferrand</city>
        <zip>63000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cabinet Medical des Drs Prizac-Desbonnet Scottez</name>
      <address>
        <city>Douai</city>
        <zip>59500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nimes - Hôpital Carémeau</name>
      <address>
        <city>Nimes Cedex</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Sainte Anne</name>
      <address>
        <city>Paris</city>
        <zip>75674</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Guillaume Regnier</name>
      <address>
        <city>Rennes Cedex</city>
        <zip>35011</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurologische Praxis Dr. Schoell &amp; Kollegen</name>
      <address>
        <city>Bad Homburg</city>
        <zip>61348</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Chemnitz gGmbH</name>
      <address>
        <city>Chemnitz</city>
        <zip>09131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Carl Gustav Carcus Dresden</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Somni Bene GmbH</name>
      <address>
        <city>Schwerin</city>
        <zip>19053</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hongo Todaimae Mental Clinic</name>
      <address>
        <city>Bunkyo-ku</city>
        <zip>113-0033</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kuramitsu Hospital</name>
      <address>
        <city>Fukuoka-shi</city>
        <zip>819-0037</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Center for Global Health and Medicine, Kohnodai hospital</name>
      <address>
        <city>Ichikawa-shi</city>
        <zip>272-8516</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Hizen Psychiatric Center</name>
      <address>
        <city>Kanzaki-gun</city>
        <zip>842-0192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nara Medical University Hospital</name>
      <address>
        <city>Kashihara-shi</city>
        <zip>634-8522</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Senzoku Mental Clinic</name>
      <address>
        <city>Meguro-ku</city>
        <zip>152-0012</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart Care Ginga Clinic</name>
      <address>
        <city>Nakano-ku</city>
        <zip>164-0012</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shiranui Hospital</name>
      <address>
        <city>Omuta-shi</city>
        <zip>836-0004</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seiwakai Yutaka Clinic</name>
      <address>
        <city>Sagamihara-shi</city>
        <zip>252-0303</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sangenjaya Nakamura Mental Clinic</name>
      <address>
        <city>Setagaya-ku</city>
        <zip>154-0004</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yoyogi Mental Clinic</name>
      <address>
        <city>Shibuya-ku</city>
        <zip>151-0051</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Etoh Mental Clinic</name>
      <address>
        <city>Shinagawa-ku</city>
        <zip>141-0021</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nishi-Shinjuku Concieria Clinic</name>
      <address>
        <city>Shinjuku-ku</city>
        <zip>160-0023</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tamaki Clinic</name>
      <address>
        <city>Shinjuku-ku</city>
        <zip>160-0023</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shinjuku Research Park Clinic</name>
      <address>
        <city>Shinjuku-ku</city>
        <zip>169-0073</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohwa Mental Clinic</name>
      <address>
        <city>Toshima-ku</city>
        <zip>170-0002</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sekino Hospital</name>
      <address>
        <city>Toshima-ku</city>
        <zip>171-0014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jisenkai Hozumi Himorogi Clinic</name>
      <address>
        <city>Toshima-ku</city>
        <zip>171-0022</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SHI Arkhangelsk Regional Clinical Psychiatric Hospital</name>
      <address>
        <city>Arkhangelsk</city>
        <zip>163530</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sverdlov Regional Psychiatric Clinical Hospital</name>
      <address>
        <city>Ekaterinburg</city>
        <zip>620030</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Clinical Psychiatric Hopsital 3</name>
      <address>
        <city>Moscow</city>
        <zip>107076</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FSI Moscow SRI of Psychiatry of Minzdravsocrazvitia</name>
      <address>
        <city>Moscow</city>
        <zip>107076</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Closed corporation 'Scientific Center of Personalized Psychiatry'</name>
      <address>
        <city>Moscow</city>
        <zip>119180</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Moscow State Medical University n.a. I.M. Sechenov</name>
      <address>
        <city>Moscow</city>
        <zip>119991</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Psychiatry Hospital n.a. N.N. Solodovnikov</name>
      <address>
        <city>Omsk</city>
        <zip>644070</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical and Rehabilitation Research Center Phoenix</name>
      <address>
        <city>Rostov-on-Don</city>
        <zip>344010</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Psychiatric Hospital of St. Nikolay Chudotvorets</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>190121</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Engels psychiatric hospital</name>
      <address>
        <city>Saratov Region</city>
        <zip>413124</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SHI 'Saratov City Clinical Hospital 2 n.a V.I. Razumovsky</name>
      <address>
        <city>Saratov</city>
        <zip>410028</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St-Petersburg Bekhterev Psychoneurological Research Institute</name>
      <address>
        <city>St. Petersburg</city>
        <zip>192019</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Institute of Mental Health</name>
      <address>
        <city>Tomsk</city>
        <zip>634014</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CNCE'Precarpathian Regional Clinical Mental Health Center Ivano-Frankivsk RC'</name>
      <address>
        <city>Ivano-Frankivsk</city>
        <zip>76014</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3'</name>
      <address>
        <city>Kharkiv</city>
        <zip>61068</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cnce 'Kyiv City Psychoneurological Hospital #2' of Executive Body of Kyiv City Council (Kcsa)</name>
      <address>
        <city>Kyiv</city>
        <zip>2660</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CNCE of the Lviv Regional Council 'Lviv Regional Clinical Psychiatric Hospital'</name>
      <address>
        <city>Lviv</city>
        <zip>79021</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CI Odesa Regional Medical Center of Mental Health</name>
      <address>
        <city>Odesa</city>
        <zip>65006</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CNCE Odesa regional psychiatric hospital #2 Odesa regional council</name>
      <address>
        <city>Oleksandrivka</city>
        <zip>67513</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Poltava O.F. Maltsev RC Psychiatric Hospital Dept #9 (Ad-P Dept) HSEIU Ukrainian MSA</name>
      <address>
        <city>Poltava</city>
        <zip>36006</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ternopil RCCPH Depts of Psychiatry #2 (m) &amp; Psychiatry #4 (f) Ternopil I.Ya. Gorbachevskyi SMU</name>
      <address>
        <city>Ternopil</city>
        <zip>46020</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CI O.I. Yuschenko VRPsH Depts #7 &amp; #10 M.I. Pyrogov VNMU</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21005</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CNCE 'Vinnytsya RC Psychoneurological Hospital n.a. O.I. Yushchenko Vinnytsya RC'</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21005</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <country>Finland</country>
    <country>France</country>
    <country>Germany</country>
    <country>Japan</country>
    <country>Russian Federation</country>
    <country>Ukraine</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <results_first_submitted>December 24, 2021</results_first_submitted>
  <results_first_submitted_qc>February 4, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">February 7, 2022</results_first_posted>
  <disposition_first_submitted>January 8, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>February 4, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">February 7, 2022</disposition_first_posted>
  <last_update_submitted>June 30, 2023</last_update_submitted>
  <last_update_submitted_qc>June 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 24, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT03227224/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 6, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT03227224/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
        </group>
        <group group_id="P2">
          <title>Seltorexant 10 mg</title>
          <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
        </group>
        <group group_id="P3">
          <title>Seltorexant 20 mg</title>
          <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
        </group>
        <group group_id="P4">
          <title>Seltorexant 40 mg</title>
          <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Double-blind Treatment Period (6 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="138"/>
                <participants group_id="P2" count="33"/>
                <participants group_id="P3" count="63"/>
                <participants group_id="P4" count="53"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="137"/>
                <participants group_id="P2" count="33"/>
                <participants group_id="P3" count="61"/>
                <participants group_id="P4" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="123"/>
                <participants group_id="P2" count="27"/>
                <participants group_id="P3" count="55"/>
                <participants group_id="P4" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Received a Disallowed Concomitant Treatment</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-Compliance with Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Follow-up Phase (2 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="138">All participants that started the double-blind period were followed-up for follow-up phase.</participants>
                <participants group_id="P2" count="33">All participants that started the double-blind period were followed-up for follow-up phase.</participants>
                <participants group_id="P3" count="63">All participants that started the double-blind period were followed-up for follow-up phase.</participants>
                <participants group_id="P4" count="53">All participants that started the double-blind period were followed-up for follow-up phase.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="134"/>
                <participants group_id="P2" count="29"/>
                <participants group_id="P3" count="57"/>
                <participants group_id="P4" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
        </group>
        <group group_id="B2">
          <title>Seltorexant 10 mg</title>
          <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
        </group>
        <group group_id="B3">
          <title>Seltorexant 20 mg</title>
          <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
        </group>
        <group group_id="B4">
          <title>Seltorexant 40 mg</title>
          <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="137"/>
            <count group_id="B2" value="33"/>
            <count group_id="B3" value="61"/>
            <count group_id="B4" value="52"/>
            <count group_id="B5" value="283"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49.6" spread="11.71"/>
                    <measurement group_id="B2" value="49.4" spread="15.31"/>
                    <measurement group_id="B3" value="48.5" spread="13.56"/>
                    <measurement group_id="B4" value="48.3" spread="10.52"/>
                    <measurement group_id="B5" value="49.1" spread="12.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Adults (18-64 years)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="131"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="59"/>
                    <measurement group_id="B4" value="51"/>
                    <measurement group_id="B5" value="270"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>From 65 to 84 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>85 years and over</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="74"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="30"/>
                    <measurement group_id="B4" value="28"/>
                    <measurement group_id="B5" value="152"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="31"/>
                    <measurement group_id="B4" value="24"/>
                    <measurement group_id="B5" value="131"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Other Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="105"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="50"/>
                    <measurement group_id="B4" value="39"/>
                    <measurement group_id="B5" value="223"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="120"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="53"/>
                    <measurement group_id="B4" value="42"/>
                    <measurement group_id="B5" value="246"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown or Not Reported</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>BULGARIA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FINLAND</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GERMANY</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>JAPAN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RUSSIAN FEDERATION</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>UKRAINE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>UNITED STATES</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="18"/>
                    <measurement group_id="B5" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score</title>
        <description>MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score range of 0-60 which is calculated by adding the scores of all 10 items. Higher scores represent a more severe condition.</description>
        <time_frame>Baseline to Week 6</time_frame>
        <population>Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score</title>
          <description>MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score range of 0-60 which is calculated by adding the scores of all 10 items. Higher scores represent a more severe condition.</description>
          <population>Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="55"/>
                <count group_id="O4" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.3" spread="10.95"/>
                    <measurement group_id="O2" value="-12.2" spread="8.33"/>
                    <measurement group_id="O3" value="-15.0" spread="12.13"/>
                    <measurement group_id="O4" value="-14.7" spread="13.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.724</p_value>
            <method>Mixed model for repeated measures (MMRM)</method>
            <param_type>Difference of Least Square Means</param_type>
            <param_value>0.9</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.12</ci_lower_limit>
            <ci_upper_limit>4.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.083</p_value>
            <method>MMRM</method>
            <param_type>Difference of Least Square Means</param_type>
            <param_value>-3.1</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.13</ci_lower_limit>
            <ci_upper_limit>-0.16</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.424</p_value>
            <method>MMRM</method>
            <param_type>Difference of Least Square Means</param_type>
            <param_value>-1.5</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.70</ci_lower_limit>
            <ci_upper_limit>1.63</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability</title>
        <description>An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between the initial administration of study drug and 2 days after the last administration of study drug.</description>
        <time_frame>Up to Week 8</time_frame>
        <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability</title>
          <description>An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between the initial administration of study drug and 2 days after the last administration of study drug.</description>
          <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="137"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="61"/>
                <count group_id="O4" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.9"/>
                    <measurement group_id="O2" value="33.3"/>
                    <measurement group_id="O3" value="41.0"/>
                    <measurement group_id="O4" value="36.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Clinically Significant Laboratory Abnormalities</title>
        <description>Percentage of participants with clinically significant laboratory abnormalities were reported which included Gamma-glutamyl transferase (GGT), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Creatine Kinase (CK), Lactate Dehydrogenase (LDH), Albumin , bicarbonate, bilirubin, calcium, chloride, cholesterol, creatinine, direct bilirubin, glucose, high density lipoprotein (HDL) cholesterol, hemoglobin A1C, low density lipoprotein (LDL) cholesterol, phosphate, potassium, protein, sodium, triglycerides, urate, and urea nitrogen.</description>
        <time_frame>Up to Week 8</time_frame>
        <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure; n (number analyzed) signifies those participants who were evaluable for specified categories.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Clinically Significant Laboratory Abnormalities</title>
          <description>Percentage of participants with clinically significant laboratory abnormalities were reported which included Gamma-glutamyl transferase (GGT), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Creatine Kinase (CK), Lactate Dehydrogenase (LDH), Albumin , bicarbonate, bilirubin, calcium, chloride, cholesterol, creatinine, direct bilirubin, glucose, high density lipoprotein (HDL) cholesterol, hemoglobin A1C, low density lipoprotein (LDL) cholesterol, phosphate, potassium, protein, sodium, triglycerides, urate, and urea nitrogen.</description>
          <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure; n (number analyzed) signifies those participants who were evaluable for specified categories.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="137"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="61"/>
                <count group_id="O4" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ALT: Abnormally high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="60"/>
                    <count group_id="O4" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin: Abnormally low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="60"/>
                    <count group_id="O4" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin: Abnormally high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="60"/>
                    <count group_id="O4" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALP: Abnormally high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="60"/>
                    <count group_id="O4" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST: Abnormally high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="60"/>
                    <count group_id="O4" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bicarbonate: Abnormally low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="60"/>
                    <count group_id="O4" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bicarbonate: Abnormally high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="60"/>
                    <count group_id="O4" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin: Abnormally high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="137"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="61"/>
                    <count group_id="O4" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium: Abnormally low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="137"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="61"/>
                    <count group_id="O4" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium: Abnormally high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="137"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="61"/>
                    <count group_id="O4" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride: Abnormally low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="60"/>
                    <count group_id="O4" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride: Abnormally high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="60"/>
                    <count group_id="O4" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cholesterol: Abnormally high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="131"/>
                    <count group_id="O2" value="29"/>
                    <count group_id="O3" value="56"/>
                    <count group_id="O4" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CK: Abnormally high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="60"/>
                    <count group_id="O4" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1.7"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine: Abnormally high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="60"/>
                    <count group_id="O4" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Direct Bilirubin: Abnormally high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="60"/>
                    <count group_id="O4" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GGT: Abnormally high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="60"/>
                    <count group_id="O4" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose: Abnormally low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="60"/>
                    <count group_id="O4" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose: Abnormally high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="60"/>
                    <count group_id="O4" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HDL Cholesterol: Abnormally low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="131"/>
                    <count group_id="O2" value="29"/>
                    <count group_id="O3" value="55"/>
                    <count group_id="O4" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3"/>
                    <measurement group_id="O2" value="6.9"/>
                    <measurement group_id="O3" value="1.8"/>
                    <measurement group_id="O4" value="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin A1C: Abnormally low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="132"/>
                    <count group_id="O2" value="28"/>
                    <count group_id="O3" value="57"/>
                    <count group_id="O4" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin A1C: Abnormally high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="132"/>
                    <count group_id="O2" value="28"/>
                    <count group_id="O3" value="57"/>
                    <count group_id="O4" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL Cholesterol: Abnormally low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="131"/>
                    <count group_id="O2" value="29"/>
                    <count group_id="O3" value="54"/>
                    <count group_id="O4" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6"/>
                    <measurement group_id="O2" value="10.3"/>
                    <measurement group_id="O3" value="9.3"/>
                    <measurement group_id="O4" value="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL Cholesterol: Abnormally high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="131"/>
                    <count group_id="O2" value="29"/>
                    <count group_id="O3" value="54"/>
                    <count group_id="O4" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.6"/>
                    <measurement group_id="O2" value="6.9"/>
                    <measurement group_id="O3" value="1.9"/>
                    <measurement group_id="O4" value="11.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDH: Abnormally high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="60"/>
                    <count group_id="O4" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phosphate: Abnormally low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="60"/>
                    <count group_id="O4" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7"/>
                    <measurement group_id="O2" value="3.2"/>
                    <measurement group_id="O3" value="3.3"/>
                    <measurement group_id="O4" value="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phosphate: Abnormally high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="60"/>
                    <count group_id="O4" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium: Abnormally low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="60"/>
                    <count group_id="O4" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium: Abnormally high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="60"/>
                    <count group_id="O4" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7"/>
                    <measurement group_id="O2" value="3.2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein:Abnormally low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="60"/>
                    <count group_id="O4" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium: Abnormally low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="60"/>
                    <count group_id="O4" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium: Abnormally high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="60"/>
                    <count group_id="O4" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Triglycerides: Abnormally high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="131"/>
                    <count group_id="O2" value="29"/>
                    <count group_id="O3" value="55"/>
                    <count group_id="O4" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urate: Abnormally low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="60"/>
                    <count group_id="O4" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urate: Abnormally high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="60"/>
                    <count group_id="O4" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="5.0"/>
                    <measurement group_id="O4" value="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urea Nitrogen: Abnormally high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="60"/>
                    <count group_id="O4" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) at Day 8</title>
        <description>Change from baseline in vital signs (SBP and DBP) at Day 8 was reported.</description>
        <time_frame>Baseline and Day 8</time_frame>
        <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) at Day 8</title>
          <description>Change from baseline in vital signs (SBP and DBP) at Day 8 was reported.</description>
          <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure.</population>
          <units>millimeters of mercury (mmHg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="136"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="60"/>
                <count group_id="O4" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Standing DBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="6.29"/>
                    <measurement group_id="O2" value="-0.5" spread="5.22"/>
                    <measurement group_id="O3" value="0.7" spread="5.86"/>
                    <measurement group_id="O4" value="0.9" spread="6.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Standing SBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="8.16"/>
                    <measurement group_id="O2" value="-0.8" spread="7.19"/>
                    <measurement group_id="O3" value="0.2" spread="8.17"/>
                    <measurement group_id="O4" value="0.3" spread="9.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine DBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="6.32"/>
                    <measurement group_id="O2" value="-0.9" spread="6.19"/>
                    <measurement group_id="O3" value="2.3" spread="6.14"/>
                    <measurement group_id="O4" value="1.2" spread="6.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine SBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="8.19"/>
                    <measurement group_id="O2" value="1.6" spread="6.56"/>
                    <measurement group_id="O3" value="1.5" spread="9.57"/>
                    <measurement group_id="O4" value="0.5" spread="10.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Vital Signs (SBP and DBP) at Day 22</title>
        <description>Change from baseline in vital signs (SBP and DBP) at Day 22 was reported.</description>
        <time_frame>Baseline and Day 22</time_frame>
        <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Vital Signs (SBP and DBP) at Day 22</title>
          <description>Change from baseline in vital signs (SBP and DBP) at Day 22 was reported.</description>
          <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="132"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="58"/>
                <count group_id="O4" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Standing DBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="6.67"/>
                    <measurement group_id="O2" value="-1.2" spread="5.92"/>
                    <measurement group_id="O3" value="-0.4" spread="6.90"/>
                    <measurement group_id="O4" value="2.4" spread="7.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Standing SBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="7.01"/>
                    <measurement group_id="O2" value="-1.2" spread="6.55"/>
                    <measurement group_id="O3" value="-2.7" spread="9.62"/>
                    <measurement group_id="O4" value="1.6" spread="11.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine DBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="6.81"/>
                    <measurement group_id="O2" value="-1.8" spread="6.7"/>
                    <measurement group_id="O3" value="-0.2" spread="7.41"/>
                    <measurement group_id="O4" value="2.6" spread="6.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine SBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="8.14"/>
                    <measurement group_id="O2" value="0.3" spread="4.76"/>
                    <measurement group_id="O3" value="-0.9" spread="10.78"/>
                    <measurement group_id="O4" value="2.2" spread="10.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Vital Signs (SBP and DBP) at Day 42</title>
        <description>Change from baseline in vital signs (SBP and DBP) at Day 42 was reported.</description>
        <time_frame>Baseline and Day 42</time_frame>
        <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Vital Signs (SBP and DBP) at Day 42</title>
          <description>Change from baseline in vital signs (SBP and DBP) at Day 42 was reported.</description>
          <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="126"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="56"/>
                <count group_id="O4" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Standing DBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="6.22"/>
                    <measurement group_id="O2" value="0.3" spread="9.16"/>
                    <measurement group_id="O3" value="-0.8" spread="6.75"/>
                    <measurement group_id="O4" value="2.9" spread="7.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Standing SBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="7.99"/>
                    <measurement group_id="O2" value="1.1" spread="7.92"/>
                    <measurement group_id="O3" value="-3.2" spread="10.57"/>
                    <measurement group_id="O4" value="2.0" spread="9.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine DBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="7.1"/>
                    <measurement group_id="O2" value="-1.6" spread="9.23"/>
                    <measurement group_id="O3" value="0.0" spread="8.31"/>
                    <measurement group_id="O4" value="2.1" spread="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine SBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="8.88"/>
                    <measurement group_id="O2" value="-0.5" spread="10.00"/>
                    <measurement group_id="O3" value="-1.3" spread="10.85"/>
                    <measurement group_id="O4" value="1.9" spread="8.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Vital Signs (SBP and DBP) at Endpoint (Week 6)</title>
        <description>Change from baseline in vital signs (SBP and DBP) at endpoint was reported.</description>
        <time_frame>Baseline and Endpoint (Week 6)</time_frame>
        <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure. Endpoint (double-blind [DB]) values are from the last measurement within the double-blind period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Vital Signs (SBP and DBP) at Endpoint (Week 6)</title>
          <description>Change from baseline in vital signs (SBP and DBP) at endpoint was reported.</description>
          <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure. Endpoint (double-blind [DB]) values are from the last measurement within the double-blind period.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="136"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="60"/>
                <count group_id="O4" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Standing DBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="6.29"/>
                    <measurement group_id="O2" value="0.6" spread="8.98"/>
                    <measurement group_id="O3" value="-0.6" spread="6.78"/>
                    <measurement group_id="O4" value="2.8" spread="7.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Standing SBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="8.33"/>
                    <measurement group_id="O2" value="1.0" spread="7.42"/>
                    <measurement group_id="O3" value="-3.1" spread="10.29"/>
                    <measurement group_id="O4" value="1.8" spread="9.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine DBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="7.08"/>
                    <measurement group_id="O2" value="-1.4" spread="9.34"/>
                    <measurement group_id="O3" value="0.2" spread="8.35"/>
                    <measurement group_id="O4" value="2.3" spread="7.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine SBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="8.81"/>
                    <measurement group_id="O2" value="-0.3" spread="9.38"/>
                    <measurement group_id="O3" value="-1.4" spread="10.52"/>
                    <measurement group_id="O4" value="1.6" spread="8.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Vital Sign (Pulse Rate [PR]) at Day 8</title>
        <description>Change from baseline in vital sign (PR) at Day 8 was reported.</description>
        <time_frame>Baseline and Day 8</time_frame>
        <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Vital Sign (Pulse Rate [PR]) at Day 8</title>
          <description>Change from baseline in vital sign (PR) at Day 8 was reported.</description>
          <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure.</population>
          <units>Beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="136"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="60"/>
                <count group_id="O4" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Standing PR</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="7.95"/>
                    <measurement group_id="O2" value="-0.7" spread="7.07"/>
                    <measurement group_id="O3" value="0.9" spread="9.17"/>
                    <measurement group_id="O4" value="1.3" spread="9.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine PR</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="7.15"/>
                    <measurement group_id="O2" value="-1.2" spread="7.16"/>
                    <measurement group_id="O3" value="0.5" spread="6.23"/>
                    <measurement group_id="O4" value="1.7" spread="9.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Vital Sign (PR) at Day 22</title>
        <description>Change from baseline in vital sign (PR) at Day 22 was reported.</description>
        <time_frame>Baseline and Day 22</time_frame>
        <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Vital Sign (PR) at Day 22</title>
          <description>Change from baseline in vital sign (PR) at Day 22 was reported.</description>
          <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure.</population>
          <units>Beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="132"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="58"/>
                <count group_id="O4" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Standing PR</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="7.57"/>
                    <measurement group_id="O2" value="0.7" spread="7.36"/>
                    <measurement group_id="O3" value="1.5" spread="8.27"/>
                    <measurement group_id="O4" value="0.3" spread="9.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine PR</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="7.61"/>
                    <measurement group_id="O2" value="-0.7" spread="7.31"/>
                    <measurement group_id="O3" value="2.8" spread="7.94"/>
                    <measurement group_id="O4" value="0.9" spread="10.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Vital Sign (PR) at Day 42</title>
        <description>Change from baseline in vital sign (PR) at Day 42 was reported.</description>
        <time_frame>Baseline and Day 42</time_frame>
        <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Vital Sign (PR) at Day 42</title>
          <description>Change from baseline in vital sign (PR) at Day 42 was reported.</description>
          <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure.</population>
          <units>Beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="126"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="56"/>
                <count group_id="O4" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Standing PR</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="7.99"/>
                    <measurement group_id="O2" value="-1.4" spread="9.35"/>
                    <measurement group_id="O3" value="1.5" spread="8.99"/>
                    <measurement group_id="O4" value="-0.6" spread="9.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine PR</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="8.16"/>
                    <measurement group_id="O2" value="-2.8" spread="8.67"/>
                    <measurement group_id="O3" value="2.4" spread="9.01"/>
                    <measurement group_id="O4" value="-0.6" spread="9.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Vital Sign (PR) at Endpoint (Week 6)</title>
        <description>Change from baseline in vital sign (PR) at endpoint (Week 6) was reported.</description>
        <time_frame>Baseline and Endpoint (Week 6)</time_frame>
        <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure. Endpoint (DB) values are from the last measurement within the double-blind period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Vital Sign (PR) at Endpoint (Week 6)</title>
          <description>Change from baseline in vital sign (PR) at endpoint (Week 6) was reported.</description>
          <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure. Endpoint (DB) values are from the last measurement within the double-blind period.</population>
          <units>Beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="136"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="60"/>
                <count group_id="O4" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Standing PR</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="8.4"/>
                    <measurement group_id="O2" value="-1.6" spread="9.27"/>
                    <measurement group_id="O3" value="2.1" spread="9.34"/>
                    <measurement group_id="O4" value="-0.5" spread="9.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine PR</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="8.16"/>
                    <measurement group_id="O2" value="-2.4" spread="8.97"/>
                    <measurement group_id="O3" value="2.4" spread="8.78"/>
                    <measurement group_id="O4" value="-0.5" spread="9.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Vital Sign (Temperature) at Day 8</title>
        <description>Change from baseline in vital Sign (temperature) at Day 8 was reported.</description>
        <time_frame>Baseline and Day 8</time_frame>
        <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Vital Sign (Temperature) at Day 8</title>
          <description>Change from baseline in vital Sign (temperature) at Day 8 was reported.</description>
          <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure.</population>
          <units>Celsius</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="136"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="60"/>
                <count group_id="O4" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" spread="0.324"/>
                    <measurement group_id="O2" value="-0.05" spread="0.274"/>
                    <measurement group_id="O3" value="0.02" spread="0.278"/>
                    <measurement group_id="O4" value="0.06" spread="0.300"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Vital Sign (Temperature) at Day 22</title>
        <description>Change from baseline in vital Sign (temperature) at Day 22 was reported.</description>
        <time_frame>Baseline and Day 22</time_frame>
        <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Vital Sign (Temperature) at Day 22</title>
          <description>Change from baseline in vital Sign (temperature) at Day 22 was reported.</description>
          <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure.</population>
          <units>Celsius</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="132"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="58"/>
                <count group_id="O4" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.299"/>
                    <measurement group_id="O2" value="-0.01" spread="0.242"/>
                    <measurement group_id="O3" value="-0.02" spread="0.332"/>
                    <measurement group_id="O4" value="0.02" spread="0.392"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Vital Sign (Temperature) at Day 42</title>
        <description>Change from baseline in vital Sign (temperature) at Day 42 was reported.</description>
        <time_frame>Baseline and Day 42</time_frame>
        <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Vital Sign (Temperature) at Day 42</title>
          <description>Change from baseline in vital Sign (temperature) at Day 42 was reported.</description>
          <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure.</population>
          <units>Celsius</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="126"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="56"/>
                <count group_id="O4" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.326"/>
                    <measurement group_id="O2" value="-0.04" spread="0.291"/>
                    <measurement group_id="O3" value="-0.05" spread="0.223"/>
                    <measurement group_id="O4" value="0.05" spread="0.445"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Vital Sign (Temperature) at Endpoint (Week 6)</title>
        <description>Change from baseline in vital Sign (temperature) at endpoint (Week 6) was reported.</description>
        <time_frame>Baseline and Endpoint (Week 6)</time_frame>
        <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure. Endpoint (DB) values are from the last measurement within the double-blind period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Vital Sign (Temperature) at Endpoint (Week 6)</title>
          <description>Change from baseline in vital Sign (temperature) at endpoint (Week 6) was reported.</description>
          <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure. Endpoint (DB) values are from the last measurement within the double-blind period.</population>
          <units>Celsius</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="136"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="60"/>
                <count group_id="O4" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.317"/>
                    <measurement group_id="O2" value="-0.03" spread="0.276"/>
                    <measurement group_id="O3" value="-0.06" spread="0.242"/>
                    <measurement group_id="O4" value="0.06" spread="0.437"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Physical Examination (Waist Circumference) at Day 42</title>
        <description>Change from baseline in physical examination (waist circumference) was reported.</description>
        <time_frame>Baseline and Day 42</time_frame>
        <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Physical Examination (Waist Circumference) at Day 42</title>
          <description>Change from baseline in physical examination (waist circumference) was reported.</description>
          <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.</population>
          <units>centimeters (cm)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="134"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="58"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.31" spread="2.778"/>
                    <measurement group_id="O2" value="-0.50" spread="1.972"/>
                    <measurement group_id="O3" value="0.00" spread="3.523"/>
                    <measurement group_id="O4" value="-0.48" spread="9.498"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Physical Examination (Body Weight) at Day 42</title>
        <description>Change from baseline in physical examination (body weight) was reported.</description>
        <time_frame>Baseline and Day 42</time_frame>
        <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Physical Examination (Body Weight) at Day 42</title>
          <description>Change from baseline in physical examination (body weight) was reported.</description>
          <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.</population>
          <units>Kilograms (kg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="134"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="58"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.19" spread="2.373"/>
                    <measurement group_id="O2" value="0.01" spread="1.889"/>
                    <measurement group_id="O3" value="0.05" spread="1.563"/>
                    <measurement group_id="O4" value="0.61" spread="1.946"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Physical Examination (Body Mass Index [BMI]) at Day 42</title>
        <description>Change from baseline in physical examination (BMI) was reported.</description>
        <time_frame>Baseline and Day 42</time_frame>
        <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Physical Examination (Body Mass Index [BMI]) at Day 42</title>
          <description>Change from baseline in physical examination (BMI) was reported.</description>
          <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.</population>
          <units>kilograms per meter square (kg/m^2)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="134"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="58"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" spread="0.850"/>
                    <measurement group_id="O2" value="0.01" spread="0.662"/>
                    <measurement group_id="O3" value="0.02" spread="0.553"/>
                    <measurement group_id="O4" value="0.22" spread="0.715"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values Outside Pre-defined Limits</title>
        <description>Percentage of participants with treatment-emergent abnormal ECG values (Heart rate less than or equal to [&lt;=] 50 or greater than or equal to [&gt;=] 100 beats per minute [bpm], PR interval &lt;=120 or &gt;=200 milliseconds [msec], QRS interval &lt;=60 or &gt;=120 msec, and QT interval &lt;=200 or &gt;=500 msec) outside pre-defined limits were reported.</description>
        <time_frame>Up to Week 6</time_frame>
        <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure; n (number analyzed) signifies those participants who were evaluable for specified categories.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values Outside Pre-defined Limits</title>
          <description>Percentage of participants with treatment-emergent abnormal ECG values (Heart rate less than or equal to [&lt;=] 50 or greater than or equal to [&gt;=] 100 beats per minute [bpm], PR interval &lt;=120 or &gt;=200 milliseconds [msec], QRS interval &lt;=60 or &gt;=120 msec, and QT interval &lt;=200 or &gt;=500 msec) outside pre-defined limits were reported.</description>
          <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure; n (number analyzed) signifies those participants who were evaluable for specified categories.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="134"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="58"/>
                <count group_id="O4" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Heart rate (&lt;=50)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="58"/>
                    <count group_id="O4" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3.4"/>
                    <measurement group_id="O4" value="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heart rate (&gt;=100)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="58"/>
                    <count group_id="O4" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1.7"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PR interval (&lt;=120)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="58"/>
                    <count group_id="O4" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PR interval (&gt;=200)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="58"/>
                    <count group_id="O4" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1.7"/>
                    <measurement group_id="O4" value="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS interval (&lt;=60)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="58"/>
                    <count group_id="O4" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS interval (&gt;=120)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="58"/>
                    <count group_id="O4" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3.3"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QT interval (&lt;=200)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="58"/>
                    <count group_id="O4" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QT interval (&gt;=500)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="58"/>
                    <count group_id="O4" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3.3"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Most Severe Post-baseline Potentially Suicide-Related Category Using Columbia Suicide Severity Rating Scale (C-SSRS)</title>
        <description>C-SSRS is a clinician-rated instrument that reports severity of both suicidal ideation and behavior. Suicidal ideation was classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods [not plan] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. Minimum total score 0, maximum total score 5; higher total scores indicate more suicidal ideation and/or suicidal behavior. If no events qualify for score of 1 to 10, score of 0 was assigned (0= &quot;no event that can be assessed on the basis of C-SSRS&quot;). Higher scores indicate greater severity.</description>
        <time_frame>Up to Week 8</time_frame>
        <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Most Severe Post-baseline Potentially Suicide-Related Category Using Columbia Suicide Severity Rating Scale (C-SSRS)</title>
          <description>C-SSRS is a clinician-rated instrument that reports severity of both suicidal ideation and behavior. Suicidal ideation was classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods [not plan] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. Minimum total score 0, maximum total score 5; higher total scores indicate more suicidal ideation and/or suicidal behavior. If no events qualify for score of 1 to 10, score of 0 was assigned (0= &quot;no event that can be assessed on the basis of C-SSRS&quot;). Higher scores indicate greater severity.</description>
          <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="136"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="60"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No Event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.9"/>
                    <measurement group_id="O2" value="96.9"/>
                    <measurement group_id="O3" value="96.7"/>
                    <measurement group_id="O4" value="94.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Suicidal ideation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1"/>
                    <measurement group_id="O2" value="3.1"/>
                    <measurement group_id="O3" value="3.3"/>
                    <measurement group_id="O4" value="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Suicidal behavior</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Sexual Functioning as Measured by Arizona Sexual Experiences Scale (ASEX) Score at Day 42</title>
        <description>Effect on sexual functioning was assessed using the ASEX score. The ASEX is a five-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Each of the 5 items is rated on a 6-point scale, ranging from 1 to 6. The 5 items are summed to create a total score, ranging from 5 to 30, with the higher scores indicating more sexual dysfunction.</description>
        <time_frame>Baseline and Day 42</time_frame>
        <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Sexual Functioning as Measured by Arizona Sexual Experiences Scale (ASEX) Score at Day 42</title>
          <description>Effect on sexual functioning was assessed using the ASEX score. The ASEX is a five-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Each of the 5 items is rated on a 6-point scale, ranging from 1 to 6. The 5 items are summed to create a total score, ranging from 5 to 30, with the higher scores indicating more sexual dysfunction.</description>
          <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="133"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="58"/>
                <count group_id="O4" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.4" spread="4.55"/>
                    <measurement group_id="O2" value="-2.2" spread="3.62"/>
                    <measurement group_id="O3" value="-2.4" spread="4.55"/>
                    <measurement group_id="O4" value="-2.5" spread="4.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Physician Withdrawal Checklist-20 (PWC-20) Total Score at Day 43</title>
        <description>Intensity of discontinuation symptoms was assessed (for example: underlying depression; anxiety-nervousness; dysphoric mood/depression; difficulty concentrating; weakness; fatigue-lethargy-lack of energy; irritability), using the Physician Withdrawal Checklist (PWC-20) administered by a trained clinician/rater. Symptoms are rated on a scale 0 (No symptom present) and 3 (severe symptoms). Total scores range from 0 to 24 calculated by adding the scores of following 8 items: Nausea-Vomiting, Diarrhea, Poor Coordination, Diaphoresis, Tremor-Tremulousness, Dizziness-Lightheadedness, Increased Acuity Sound Smell Touch, Paresthesias. Higher scores indicating more severe symptoms.</description>
        <time_frame>Day 43</time_frame>
        <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Physician Withdrawal Checklist-20 (PWC-20) Total Score at Day 43</title>
          <description>Intensity of discontinuation symptoms was assessed (for example: underlying depression; anxiety-nervousness; dysphoric mood/depression; difficulty concentrating; weakness; fatigue-lethargy-lack of energy; irritability), using the Physician Withdrawal Checklist (PWC-20) administered by a trained clinician/rater. Symptoms are rated on a scale 0 (No symptom present) and 3 (severe symptoms). Total scores range from 0 to 24 calculated by adding the scores of following 8 items: Nausea-Vomiting, Diarrhea, Poor Coordination, Diaphoresis, Tremor-Tremulousness, Dizziness-Lightheadedness, Increased Acuity Sound Smell Touch, Paresthesias. Higher scores indicating more severe symptoms.</description>
          <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="134"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="58"/>
                <count group_id="O4" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="1.68"/>
                    <measurement group_id="O2" value="0.2" spread="0.6"/>
                    <measurement group_id="O3" value="0.7" spread="1.6"/>
                    <measurement group_id="O4" value="0.5" spread="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the MADRS Total Score by Baseline Insomnia Severity Index (ISI) Score at Day 42</title>
        <description>MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score range of 0-60 which is calculated by adding the scores of all 10 items. Higher scores represent a more severe condition. The ISI has 7 questions, each rated on a 5-point Likert scale ranging from 0 to 4. The total score is calculated as the sum of the 7 items ranging from 0 to 28. Higher scores represent a more severe condition.</description>
        <time_frame>Baseline and Day 42</time_frame>
        <population>Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure; 'n' (number analyzed) signifies those participants who were evaluable for specific category.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the MADRS Total Score by Baseline Insomnia Severity Index (ISI) Score at Day 42</title>
          <description>MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score range of 0-60 which is calculated by adding the scores of all 10 items. Higher scores represent a more severe condition. The ISI has 7 questions, each rated on a 5-point Likert scale ranging from 0 to 4. The total score is calculated as the sum of the 7 items ranging from 0 to 28. Higher scores represent a more severe condition.</description>
          <population>Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure; 'n' (number analyzed) signifies those participants who were evaluable for specific category.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="55"/>
                <count group_id="O4" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 42: Baseline ISI score per IWRS less than (&lt;)15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="23"/>
                    <count group_id="O4" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.3" spread="10.83"/>
                    <measurement group_id="O2" value="-12.6" spread="8.01"/>
                    <measurement group_id="O3" value="-13.0" spread="11.38"/>
                    <measurement group_id="O4" value="-14.9" spread="12.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 42: Baseline ISI score per IWRS&gt;=15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="32"/>
                    <count group_id="O4" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.6" spread="11.06"/>
                    <measurement group_id="O2" value="-10.4" spread="10.41"/>
                    <measurement group_id="O3" value="-16.5" spread="12.62"/>
                    <measurement group_id="O4" value="-14.6" spread="13.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in ISI Total Score at DB Endpoint (Up to Week 6)</title>
        <description>The ISI is a commonly used, 7-item psychometrically validated measure used to rate insomnia. Each item is scored 0 (no problem) to 4 (very big problem) with total between 0-28 which is calculated by adding the scores of all 7 items (absence of insomnia [0-7]; sub-threshold insomnia [8-14]; moderate insomnia [15-21]; and severe insomnia [22-28]). The change in ISI total score from baseline at DB endpoint was evaluated. Negative change in score indicates improvement.</description>
        <time_frame>Baseline and DB Endpoint (Up to Week 6)</time_frame>
        <population>Full analysis set included participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here 'N' (number of participants analyzed) signifies the evaluable participants for this outcome measure. Endpoint (DB) values are from the last measurement within the double-blind period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in ISI Total Score at DB Endpoint (Up to Week 6)</title>
          <description>The ISI is a commonly used, 7-item psychometrically validated measure used to rate insomnia. Each item is scored 0 (no problem) to 4 (very big problem) with total between 0-28 which is calculated by adding the scores of all 7 items (absence of insomnia [0-7]; sub-threshold insomnia [8-14]; moderate insomnia [15-21]; and severe insomnia [22-28]). The change in ISI total score from baseline at DB endpoint was evaluated. Negative change in score indicates improvement.</description>
          <population>Full analysis set included participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here 'N' (number of participants analyzed) signifies the evaluable participants for this outcome measure. Endpoint (DB) values are from the last measurement within the double-blind period.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="134"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="58"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.3" spread="6.73"/>
                    <measurement group_id="O2" value="-4.9" spread="6.22"/>
                    <measurement group_id="O3" value="-8.7" spread="6.91"/>
                    <measurement group_id="O4" value="-8.5" spread="8.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Response on Depressive Symptoms Scale Based on MADRS Total Score</title>
        <description>Responders are defined as participants with a &gt;=50 percent (%) improvement in the MADRS total score from baseline to a given timepoint. MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score range of 0-60 which is calculated by adding the scores of all 10 items. Higher scores represent a more severe condition. Participants with missing values at a given time point were imputed as non-responders.</description>
        <time_frame>Day 42</time_frame>
        <population>Full analysis set included participants who were randomly assigned to study drug and received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Response on Depressive Symptoms Scale Based on MADRS Total Score</title>
          <description>Responders are defined as participants with a &gt;=50 percent (%) improvement in the MADRS total score from baseline to a given timepoint. MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score range of 0-60 which is calculated by adding the scores of all 10 items. Higher scores represent a more severe condition. Participants with missing values at a given time point were imputed as non-responders.</description>
          <population>Full analysis set included participants who were randomly assigned to study drug and received at least 1 dose of study drug.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="137"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="61"/>
                <count group_id="O4" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.5"/>
                    <measurement group_id="O2" value="24.2"/>
                    <measurement group_id="O3" value="41.0"/>
                    <measurement group_id="O4" value="38.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Remission of Depressive Symptoms Based on MADRS Total Score</title>
        <description>Participants with a MADRS total score of less than or equal to (&lt;=) 8, &lt;=10, and &lt;=12 at a given time point were considered as remitters. MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score range of 0-60 which is calculated by adding the scores of all 10 items. Higher scores represent a more severe condition. Participants with missing values at a given time point were imputed as non-responders.</description>
        <time_frame>Day 42</time_frame>
        <population>Full analysis set included participants who were randomly assigned to study drug and received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Remission of Depressive Symptoms Based on MADRS Total Score</title>
          <description>Participants with a MADRS total score of less than or equal to (&lt;=) 8, &lt;=10, and &lt;=12 at a given time point were considered as remitters. MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score range of 0-60 which is calculated by adding the scores of all 10 items. Higher scores represent a more severe condition. Participants with missing values at a given time point were imputed as non-responders.</description>
          <population>Full analysis set included participants who were randomly assigned to study drug and received at least 1 dose of study drug.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="137"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="61"/>
                <count group_id="O4" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MADRS (&lt;=12)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.0"/>
                    <measurement group_id="O2" value="15.2"/>
                    <measurement group_id="O3" value="29.5"/>
                    <measurement group_id="O4" value="26.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MADRS (&lt;=10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.5"/>
                    <measurement group_id="O2" value="9.1"/>
                    <measurement group_id="O3" value="26.2"/>
                    <measurement group_id="O4" value="26.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MADRS (&lt;=8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.1"/>
                    <measurement group_id="O2" value="6.1"/>
                    <measurement group_id="O3" value="23.0"/>
                    <measurement group_id="O4" value="19.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Structured Interview Guide for the Hamilton Anxiety Rating Scale (HAM-A) Total Score at Day 42</title>
        <description>HAM-A is a 14-item scale designed to measure anxiety in individuals. Each question reflects a symptom of anxiety and physical as well as mental symptoms are represented. Each of the 14-items in the scale is scored on a 5-point scale, ranging from 0 (a complete lack of that symptom) to 4 (a very severe show of anxiety with that symptom). The total score ranges from 0 to 56 which is calculated by adding the scores of all 14 items, where 0-13 indicates normal range, 14-17 indicates mild severity, 18 -24: mild to moderate severity, 25 -30: moderate to severe, and &gt;=31: severe. Higher score indicates worsening. Negative change in score indicates improvement.</description>
        <time_frame>Baseline and Day 42</time_frame>
        <population>Full analysis set included participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here 'N' (number of participants analyzed) signifies the evaluable participants for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Structured Interview Guide for the Hamilton Anxiety Rating Scale (HAM-A) Total Score at Day 42</title>
          <description>HAM-A is a 14-item scale designed to measure anxiety in individuals. Each question reflects a symptom of anxiety and physical as well as mental symptoms are represented. Each of the 14-items in the scale is scored on a 5-point scale, ranging from 0 (a complete lack of that symptom) to 4 (a very severe show of anxiety with that symptom). The total score ranges from 0 to 56 which is calculated by adding the scores of all 14 items, where 0-13 indicates normal range, 14-17 indicates mild severity, 18 -24: mild to moderate severity, 25 -30: moderate to severe, and &gt;=31: severe. Higher score indicates worsening. Negative change in score indicates improvement.</description>
          <population>Full analysis set included participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here 'N' (number of participants analyzed) signifies the evaluable participants for this outcome measure.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="126"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="56"/>
                <count group_id="O4" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.7" spread="7.92"/>
                    <measurement group_id="O2" value="-9.9" spread="5.57"/>
                    <measurement group_id="O3" value="-9.6" spread="9.31"/>
                    <measurement group_id="O4" value="-9.9" spread="10.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Response on Anxiety Symptoms Scale Based on HAM-A Total Score</title>
        <description>Participants with a &gt;=50 percent improvement in the HAM-A total score from baseline at a given timepoint were considered as responders. HAM-A is a 14-item scale designed to measure anxiety in individuals. Each question reflects a symptom of anxiety and physical as well as mental symptoms are represented. Each of the 14-items in the scale is scored on a 5-point scale, ranging from 0 (a complete lack of that symptom) to 4 (a very severe show of anxiety with that symptom). The total score ranges from 0 to 56 which is calculated by adding the scores of all 14 items, where 0-13 indicates normal range, 14-17 indicates mild severity, 18 -24: mild to moderate severity, 25 -30: moderate to severe, and &gt;=31: severe. Higher score indicates worsening. Participants with missing values at a given time point were imputed as non-responders.</description>
        <time_frame>Day 42</time_frame>
        <population>Full analysis set included participants who were randomly assigned to study drug and received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Response on Anxiety Symptoms Scale Based on HAM-A Total Score</title>
          <description>Participants with a &gt;=50 percent improvement in the HAM-A total score from baseline at a given timepoint were considered as responders. HAM-A is a 14-item scale designed to measure anxiety in individuals. Each question reflects a symptom of anxiety and physical as well as mental symptoms are represented. Each of the 14-items in the scale is scored on a 5-point scale, ranging from 0 (a complete lack of that symptom) to 4 (a very severe show of anxiety with that symptom). The total score ranges from 0 to 56 which is calculated by adding the scores of all 14 items, where 0-13 indicates normal range, 14-17 indicates mild severity, 18 -24: mild to moderate severity, 25 -30: moderate to severe, and &gt;=31: severe. Higher score indicates worsening. Participants with missing values at a given time point were imputed as non-responders.</description>
          <population>Full analysis set included participants who were randomly assigned to study drug and received at least 1 dose of study drug.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="137"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="61"/>
                <count group_id="O4" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.2"/>
                    <measurement group_id="O2" value="57.6"/>
                    <measurement group_id="O3" value="50.8"/>
                    <measurement group_id="O4" value="46.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at DB Endpoint (Up to Week 6)</title>
        <description>The CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes into account all available information, including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S is a 7-point global assessment scale that measures the clinician's impression of the severity of illness exhibited by a participant, rating according to: 1=normal (not at all ill); 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7=among the most extremely ill participants. Higher scores indicate worsening. Negative change in score indicates improvement.</description>
        <time_frame>Baseline and DB Endpoint (Up to Week 6)</time_frame>
        <population>Full analysis set included participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies participants evaluable for this outcome measure. Endpoint (DB) values are from the last measurement within the double-blind period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at DB Endpoint (Up to Week 6)</title>
          <description>The CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes into account all available information, including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S is a 7-point global assessment scale that measures the clinician's impression of the severity of illness exhibited by a participant, rating according to: 1=normal (not at all ill); 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7=among the most extremely ill participants. Higher scores indicate worsening. Negative change in score indicates improvement.</description>
          <population>Full analysis set included participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies participants evaluable for this outcome measure. Endpoint (DB) values are from the last measurement within the double-blind period.</population>
          <units>Units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="135"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="60"/>
                <count group_id="O4" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" lower_limit="-5" upper_limit="2"/>
                    <measurement group_id="O2" value="-1.0" lower_limit="-3" upper_limit="1"/>
                    <measurement group_id="O3" value="-1.0" lower_limit="-5" upper_limit="1"/>
                    <measurement group_id="O4" value="-1.0" lower_limit="-5" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Sheehan Disability Scale (SDS) Score at Day 42</title>
        <description>The SDS is a 5-item questionnaire which has been widely used and accepted for assessment of functional impairment and associated disability. The first 3 items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a 0-10 rating scale. The scores for the first 3 items are summed to create a total score of 0-30, where a higher score indicates greater impairment. It also has 1 item on days lost from school or work and 1 item on days when underproductive. Negative change in score indicates improvement.</description>
        <time_frame>Baseline and Day 42</time_frame>
        <population>Full analysis set included participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Sheehan Disability Scale (SDS) Score at Day 42</title>
          <description>The SDS is a 5-item questionnaire which has been widely used and accepted for assessment of functional impairment and associated disability. The first 3 items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a 0-10 rating scale. The scores for the first 3 items are summed to create a total score of 0-30, where a higher score indicates greater impairment. It also has 1 item on days lost from school or work and 1 item on days when underproductive. Negative change in score indicates improvement.</description>
          <population>Full analysis set included participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.9" spread="6.99"/>
                    <measurement group_id="O2" value="-7.5" spread="5.19"/>
                    <measurement group_id="O3" value="-7.9" spread="7.46"/>
                    <measurement group_id="O4" value="-5.9" spread="9.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the MADRS Total Score at Day 42 in Participants With Major Depressive Disorder (MDD) With Anxious Distress Versus Participants With MDD Without Anxious Distress</title>
        <description>MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score range of 0-60 which is calculated by adding the scores of all 10 items. Higher scores represent a more severe condition. Negative change in score indicates improvement.</description>
        <time_frame>Baseline and Day 42</time_frame>
        <population>Full analysis set included participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure; 'n' (number analyzed) signifies those participants who were evaluable for specific category.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the MADRS Total Score at Day 42 in Participants With Major Depressive Disorder (MDD) With Anxious Distress Versus Participants With MDD Without Anxious Distress</title>
          <description>MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score range of 0-60 which is calculated by adding the scores of all 10 items. Higher scores represent a more severe condition. Negative change in score indicates improvement.</description>
          <population>Full analysis set included participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure; 'n' (number analyzed) signifies those participants who were evaluable for specific category.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="55"/>
                <count group_id="O4" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MDD with Anxious Distress</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.9" spread="11.50"/>
                    <measurement group_id="O2" value="-11.0" spread="8.67"/>
                    <measurement group_id="O3" value="-16.9" spread="12.31"/>
                    <measurement group_id="O4" value="-15.3" spread="13.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MDD without Anxious distress</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="24"/>
                    <count group_id="O4" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.7" spread="9.59"/>
                    <measurement group_id="O2" value="-13.4" spread="8.15"/>
                    <measurement group_id="O3" value="-12.5" spread="11.70"/>
                    <measurement group_id="O4" value="-13.8" spread="14.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Salivary Cortisol Levels, Measured Upon Awakening at Days 8, 22 and 42</title>
        <description>Exposure on the hypothalamic-pituitary-adrenal (HPA) axis in participants with MDD was evaluated by assessing change in salivary cortisol levels.</description>
        <time_frame>Baseline, Days 8, 22 and 42</time_frame>
        <population>Biomarker analysis set included all randomized participants who received at least 1 dose of study drug during the double-blind phase and had biomarker data at baseline. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure; 'n' (number analyzed) signifies those participants who were evaluable for specific timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Salivary Cortisol Levels, Measured Upon Awakening at Days 8, 22 and 42</title>
          <description>Exposure on the hypothalamic-pituitary-adrenal (HPA) axis in participants with MDD was evaluated by assessing change in salivary cortisol levels.</description>
          <population>Biomarker analysis set included all randomized participants who received at least 1 dose of study drug during the double-blind phase and had biomarker data at baseline. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure; 'n' (number analyzed) signifies those participants who were evaluable for specific timepoints.</population>
          <units>nanomoles per Liter (nmol/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="117"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="48"/>
                <count group_id="O4" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="116"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="48"/>
                    <count group_id="O4" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="8.41"/>
                    <measurement group_id="O2" value="0.7" spread="7.24"/>
                    <measurement group_id="O3" value="0.0" spread="8.64"/>
                    <measurement group_id="O4" value="-0.4" spread="6.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="45"/>
                    <count group_id="O4" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="8.65"/>
                    <measurement group_id="O2" value="2.1" spread="6.39"/>
                    <measurement group_id="O3" value="0.7" spread="6.75"/>
                    <measurement group_id="O4" value="1.0" spread="10.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 42</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="45"/>
                    <count group_id="O4" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="10.85"/>
                    <measurement group_id="O2" value="1.5" spread="6.15"/>
                    <measurement group_id="O3" value="-1.2" spread="6.67"/>
                    <measurement group_id="O4" value="-0.5" spread="6.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Concentrations of Seltorexant and Its Metabolites (M12 and M16)</title>
        <description>Plasma concentrations of Seltorexant and its metabolites (M12 and M16) over time were reported.</description>
        <time_frame>Day 1: Between 0.25 hours (h) to 1.5 hour, 2 to 4 hours, and 6 to 8 hours post-dose; Day 8 (morning): 6 to 12 hours post evening dose of Day 7</time_frame>
        <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure; 'n' (number analyzed) signifies those participants who were evaluable for specific timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentrations of Seltorexant and Its Metabolites (M12 and M16)</title>
          <description>Plasma concentrations of Seltorexant and its metabolites (M12 and M16) over time were reported.</description>
          <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure; 'n' (number analyzed) signifies those participants who were evaluable for specific timepoints.</population>
          <units>nanograms per milliliter (ng/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Seltorexant: Day 1, 0.25h-1.5h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="46"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="181" spread="165"/>
                    <measurement group_id="O2" value="277" spread="291"/>
                    <measurement group_id="O3" value="535" spread="500"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Seltorexant: Day 1, 2-4h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="46"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="199" spread="113"/>
                    <measurement group_id="O2" value="374" spread="232"/>
                    <measurement group_id="O3" value="647" spread="325"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Seltorexant: Day 1, 6-8h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="46"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117" spread="99.3"/>
                    <measurement group_id="O2" value="167" spread="179"/>
                    <measurement group_id="O3" value="207" spread="169"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Seltorexant: Day 8, Morning (6 to 12 hours post evening dose of Day 7)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="59"/>
                    <count group_id="O3" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.8" spread="65.8"/>
                    <measurement group_id="O2" value="69.4" spread="119"/>
                    <measurement group_id="O3" value="104" spread="203"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M12: Day 1,0.25h-1.5h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="46"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="118" spread="107"/>
                    <measurement group_id="O2" value="194" spread="223"/>
                    <measurement group_id="O3" value="357" spread="367"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M12: Day 1, 2-4h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="46"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="146" spread="58.8"/>
                    <measurement group_id="O2" value="283" spread="185"/>
                    <measurement group_id="O3" value="513" spread="284"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M12: Day 1, 6-8h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="46"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105" spread="73.5"/>
                    <measurement group_id="O2" value="187" spread="189"/>
                    <measurement group_id="O3" value="279" spread="278"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M12: Day 8, Morning (6 to 12 hours post evening dose of Day 7)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="59"/>
                    <count group_id="O3" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.2" spread="79"/>
                    <measurement group_id="O2" value="99" spread="133"/>
                    <measurement group_id="O3" value="169" spread="251"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M16: Day 1, 0.25h-1.5h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="46"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.1" spread="30.2"/>
                    <measurement group_id="O2" value="47" spread="53.4"/>
                    <measurement group_id="O3" value="71.4" spread="78.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M16: Day 1, 2-4h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="46"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3" spread="15.7"/>
                    <measurement group_id="O2" value="61.4" spread="35.7"/>
                    <measurement group_id="O3" value="101" spread="49.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M16: Day 1, 6-8h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="46"/>
                    <count group_id="O3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.5" spread="16.6"/>
                    <measurement group_id="O2" value="40.1" spread="31.4"/>
                    <measurement group_id="O3" value="70.6" spread="33.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M16: Day 8, Morning (6 to 12 hours post evening dose of Day 7)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="59"/>
                    <count group_id="O3" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.7" spread="14.9"/>
                    <measurement group_id="O2" value="37.6" spread="36.1"/>
                    <measurement group_id="O3" value="61.7" spread="43.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Depressive Symptoms Using the Patient Health Questionnaire 9-Item (PHQ-9) at DB Endpoint (Up to Week 6)</title>
        <description>The PHQ-9 is a 9-item, Patient Reported Outcome (PRO) measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) major depressive disorder (MDD) criteria. Each item is rated on a 4 point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participants item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 is categorized as follows: None-minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19) and Severe (20-27).</description>
        <time_frame>Baseline and DB Endpoint (Up to Week 6)</time_frame>
        <population>Full analysis set included participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Depressive Symptoms Using the Patient Health Questionnaire 9-Item (PHQ-9) at DB Endpoint (Up to Week 6)</title>
          <description>The PHQ-9 is a 9-item, Patient Reported Outcome (PRO) measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) major depressive disorder (MDD) criteria. Each item is rated on a 4 point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participants item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 is categorized as follows: None-minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19) and Severe (20-27).</description>
          <population>Full analysis set included participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="136"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="60"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.3" spread="6.14"/>
                    <measurement group_id="O2" value="-6.2" spread="5.48"/>
                    <measurement group_id="O3" value="-8.6" spread="6.66"/>
                    <measurement group_id="O4" value="-7.0" spread="7.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Anhedonia Using the Snaith-Hamilton Pleasure Scale (SHAPS) Score at DB Endpoint (Up to Week 6)</title>
        <description>The SHAPS is a 14-item, self-report instrument to assess hedonic capacity in adults with MDD. Each of the items has a set of 4 response categories-Definitely Agree (=1), Agree (=2), Disagree (=3), and Definitely Disagree (=4). A total score is created with either of the Disagree responses receiving a score of 1 and either of the Agree responses receiving a score of 0. The participants item responses are summed to provide a total score ranging from 0 to 14. A higher total SHAPS score indicates higher levels of current anhedonia.</description>
        <time_frame>Baseline and DB Endpoint (Up to Week 6)</time_frame>
        <population>Full analysis set included participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. Endpoint (DB) values are from the last measurement within the double-blind period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Anhedonia Using the Snaith-Hamilton Pleasure Scale (SHAPS) Score at DB Endpoint (Up to Week 6)</title>
          <description>The SHAPS is a 14-item, self-report instrument to assess hedonic capacity in adults with MDD. Each of the items has a set of 4 response categories-Definitely Agree (=1), Agree (=2), Disagree (=3), and Definitely Disagree (=4). A total score is created with either of the Disagree responses receiving a score of 1 and either of the Agree responses receiving a score of 0. The participants item responses are summed to provide a total score ranging from 0 to 14. A higher total SHAPS score indicates higher levels of current anhedonia.</description>
          <population>Full analysis set included participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. Endpoint (DB) values are from the last measurement within the double-blind period.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="136"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="60"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.6" spread="4.44"/>
                    <measurement group_id="O2" value="-2.3" spread="4.09"/>
                    <measurement group_id="O3" value="-4.2" spread="4.50"/>
                    <measurement group_id="O4" value="-3.2" spread="5.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form at DB Endpoint (Up to Week 6)</title>
        <description>The PROMIS-SD Short Form subscale consists of a static 8 item questionnaire. It assesses the concepts of sleep initiation (2 items), quality of sleep (3 items), early morning feelings (2 items) and worrying about sleep (1 item). Responses to each of the 8 items range from 1 to 5, and the range of possible summed raw scores is 8 to 40. Higher scores on the PROMIS-SD indicate more of the concept measured (disturbed sleep). Negative change in score indicates improvement.</description>
        <time_frame>Baseline and DB Endpoint (Up to Week 6)</time_frame>
        <population>Full analysis set included participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form at DB Endpoint (Up to Week 6)</title>
          <description>The PROMIS-SD Short Form subscale consists of a static 8 item questionnaire. It assesses the concepts of sleep initiation (2 items), quality of sleep (3 items), early morning feelings (2 items) and worrying about sleep (1 item). Responses to each of the 8 items range from 1 to 5, and the range of possible summed raw scores is 8 to 40. Higher scores on the PROMIS-SD indicate more of the concept measured (disturbed sleep). Negative change in score indicates improvement.</description>
          <population>Full analysis set included participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="136"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="60"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.4" spread="8.53"/>
                    <measurement group_id="O2" value="-5.1" spread="8.39"/>
                    <measurement group_id="O3" value="-10.2" spread="9.21"/>
                    <measurement group_id="O4" value="-10.9" spread="9.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Fatigue Using the Patient Reported Outcome Measurement Information System-Fatigue (PROMIS-F) Short Form Subscale Score at DB Endpoint (Up to Week 6)</title>
        <description>The PROMIS-Fatigue Short Form subscale consists of a static 8 item questionnaire. It assesses a range of symptoms from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Ratings are done on a 5-item Likert scale ranging from 0 (not at all) to 5 (very much) or 0 (never) to 5(always) depending upon the question answered. Higher scores on the PROMIS-F indicate more of the concept measured (fatigue). Negative change in score indicates improvement.</description>
        <time_frame>Baseline and DB Endpoint (Up to Week 6)</time_frame>
        <population>Full analysis set included participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. Endpoint (DB) values are from the last measurement within the double-blind period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fatigue Using the Patient Reported Outcome Measurement Information System-Fatigue (PROMIS-F) Short Form Subscale Score at DB Endpoint (Up to Week 6)</title>
          <description>The PROMIS-Fatigue Short Form subscale consists of a static 8 item questionnaire. It assesses a range of symptoms from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Ratings are done on a 5-item Likert scale ranging from 0 (not at all) to 5 (very much) or 0 (never) to 5(always) depending upon the question answered. Higher scores on the PROMIS-F indicate more of the concept measured (fatigue). Negative change in score indicates improvement.</description>
          <population>Full analysis set included participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. Endpoint (DB) values are from the last measurement within the double-blind period.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="136"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="60"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.7" spread="8.45"/>
                    <measurement group_id="O2" value="-7.4" spread="8.25"/>
                    <measurement group_id="O3" value="-9.4" spread="8.62"/>
                    <measurement group_id="O4" value="-8.0" spread="10.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Severity of Depression Using the Patient Global Impression-Severity (PGI-S) Score at DB Endpoint (Up to Week 6)</title>
        <description>The PGI-S is a self-report scale to measure severity of illness (1=none, 2=mild, 3=moderate, 4=severe). Higher score indicates more illness severity. Negative change in score indicates improvement.</description>
        <time_frame>Baseline and DB Endpoint (Up to Week 6)</time_frame>
        <population>Full analysis set included participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. Endpoint (DB) values are from the last measurement within the double-blind period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Severity of Depression Using the Patient Global Impression-Severity (PGI-S) Score at DB Endpoint (Up to Week 6)</title>
          <description>The PGI-S is a self-report scale to measure severity of illness (1=none, 2=mild, 3=moderate, 4=severe). Higher score indicates more illness severity. Negative change in score indicates improvement.</description>
          <population>Full analysis set included participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. Endpoint (DB) values are from the last measurement within the double-blind period.</population>
          <units>Units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="136"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="60"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" lower_limit="-3" upper_limit="2"/>
                    <measurement group_id="O2" value="0.0" lower_limit="-2" upper_limit="1"/>
                    <measurement group_id="O3" value="-1.0" lower_limit="-3" upper_limit="1"/>
                    <measurement group_id="O4" value="-1.0" lower_limit="-3" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Heath State Index Total Score at DB Endpoint (Up to Week 6)</title>
        <description>EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses to 5 EQ-5D-5L dimensions were scored using a utility-weighted algorithm to derive an EQ-5D-5L health status index score between 0 (death) to 100 (full health).</description>
        <time_frame>Baseline and DB Endpoint (Up to Week 6)</time_frame>
        <population>Full analysis set included participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure. Endpoint (DB) values are from the last measurement within the double-blind period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Heath State Index Total Score at DB Endpoint (Up to Week 6)</title>
          <description>EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses to 5 EQ-5D-5L dimensions were scored using a utility-weighted algorithm to derive an EQ-5D-5L health status index score between 0 (death) to 100 (full health).</description>
          <population>Full analysis set included participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure. Endpoint (DB) values are from the last measurement within the double-blind period.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="136"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="60"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.188" spread="0.2201"/>
                    <measurement group_id="O2" value="0.143" spread="0.1856"/>
                    <measurement group_id="O3" value="0.229" spread="0.2084"/>
                    <measurement group_id="O4" value="0.158" spread="0.2841"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in EQ-5D-5L Visual Analog Scale (VAS) Total Score at Endpoint (Up to Week 6)</title>
        <description>The EQ-5D-5L is a standardized instrument for use as a measure of health outcome, primarily designed for self-completion by respondents. It consists of the EQ-5D-5L descriptive system and the EQ visual analogue scale (EQ-VAS). EQ-5D-5L (describing and valuing health-related quality of life) descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the participant's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. Higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. EQ-VAS self-rating records respondent's own assessment of his/her overall health status at time of completion, on scale of 0 (worst health you can imagine) to 100 (best health you can imagine).</description>
        <time_frame>Baseline and Endpoint (up to Week 6)</time_frame>
        <population>Full analysis set included participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure. Endpoint (DB) values: last measurement within double-blind period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in EQ-5D-5L Visual Analog Scale (VAS) Total Score at Endpoint (Up to Week 6)</title>
          <description>The EQ-5D-5L is a standardized instrument for use as a measure of health outcome, primarily designed for self-completion by respondents. It consists of the EQ-5D-5L descriptive system and the EQ visual analogue scale (EQ-VAS). EQ-5D-5L (describing and valuing health-related quality of life) descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the participant's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. Higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. EQ-VAS self-rating records respondent's own assessment of his/her overall health status at time of completion, on scale of 0 (worst health you can imagine) to 100 (best health you can imagine).</description>
          <population>Full analysis set included participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure. Endpoint (DB) values: last measurement within double-blind period.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="136"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="60"/>
                <count group_id="O4" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.4" spread="20.55"/>
                    <measurement group_id="O2" value="8.9" spread="19.34"/>
                    <measurement group_id="O3" value="23.4" spread="21.18"/>
                    <measurement group_id="O4" value="20.1" spread="23.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Work Productivity and Limitations Using the Work Limitations Questionnaire (WLQ) Short Form Score at DB Endpoint (Up to Week 6)</title>
        <description>The WLQ is to assess the on-the-job impact of chronic health problems and/or treatment (&quot;work limitations&quot;) in adults. It is a 8-item questionnaire self-report rating scale developed to measure the on-the-job impact of chronic health problems and/or treatment (&quot;work limitations&quot;). It comprises five dimensions of limitations: handling time, physical, mental-interpersonal, productivity loss and output demands. Participants respond to each item with options ranging from 'Almost all of the time' to 'none of the time', or 'Does not apply to my job'. Each dimension of limitations have a scale score ranging from 0 to 100 with lower score indicating low level of work limitations.</description>
        <time_frame>Baseline and DB Endpoint (Up to Week 6)</time_frame>
        <population>Full analysis set included participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure; 'n' (number analyzed) signifies those participants who were evaluable for specific categories. Endpoint (DB) values are from the last measurement within the double-blind period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Work Productivity and Limitations Using the Work Limitations Questionnaire (WLQ) Short Form Score at DB Endpoint (Up to Week 6)</title>
          <description>The WLQ is to assess the on-the-job impact of chronic health problems and/or treatment (&quot;work limitations&quot;) in adults. It is a 8-item questionnaire self-report rating scale developed to measure the on-the-job impact of chronic health problems and/or treatment (&quot;work limitations&quot;). It comprises five dimensions of limitations: handling time, physical, mental-interpersonal, productivity loss and output demands. Participants respond to each item with options ranging from 'Almost all of the time' to 'none of the time', or 'Does not apply to my job'. Each dimension of limitations have a scale score ranging from 0 to 100 with lower score indicating low level of work limitations.</description>
          <population>Full analysis set included participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure; 'n' (number analyzed) signifies those participants who were evaluable for specific categories. Endpoint (DB) values are from the last measurement within the double-blind period.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="34"/>
                <count group_id="O4" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Time management</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="104"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21.3" spread="30.41"/>
                    <measurement group_id="O2" value="-18.2" spread="28.28"/>
                    <measurement group_id="O3" value="-21.8" spread="34.46"/>
                    <measurement group_id="O4" value="-20.8" spread="37.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical demands</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="33"/>
                    <count group_id="O4" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.2" spread="23.64"/>
                    <measurement group_id="O2" value="-23.5" spread="26.10"/>
                    <measurement group_id="O3" value="-11.7" spread="31.4"/>
                    <measurement group_id="O4" value="-14.3" spread="35.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental interpersonal scale</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="109"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="34"/>
                    <count group_id="O4" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21.2" spread="27.61"/>
                    <measurement group_id="O2" value="-19.5" spread="25.28"/>
                    <measurement group_id="O3" value="-26.28" spread="27.89"/>
                    <measurement group_id="O4" value="-15.9" spread="31.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Output demand scale</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="32"/>
                    <count group_id="O4" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-23.9" spread="26.72"/>
                    <measurement group_id="O2" value="-22.2" spread="27.8"/>
                    <measurement group_id="O3" value="-20.3" spread="30.08"/>
                    <measurement group_id="O4" value="-21.7" spread="35.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Productivity loss</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="29"/>
                    <count group_id="O4" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.1" spread="5.56"/>
                    <measurement group_id="O2" value="-4.7" spread="5.30"/>
                    <measurement group_id="O3" value="-4.7" spread="6.16"/>
                    <measurement group_id="O4" value="-4.6" spread="7.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Physician Withdrawal Checklist-20 (PWC-20) Total Score From Day 49 to Day 56</title>
        <description>Intensity of discontinuation symptoms was assessed (for example: underlying depression; anxiety-nervousness; dysphoric mood/depression; difficulty concentrating; weakness; fatigue-lethargy-lack of energy; irritability), using the Physician Withdrawal Checklist (PWC-20) administered by a trained clinician/rater. Symptoms are rated on a scale 0 (No symptom present) and 3 (severe symptoms). Total scores range from 0 to 24 calculated by adding the scores of following 8 items: Nausea-Vomiting, Diarrhea, Poor Coordination, Diaphoresis, Tremor-Tremulousness, Dizziness-Lightheadedness, Increased Acuity Sound Smell Touch, Paresthesias. Higher scores indicating more severe symptoms.</description>
        <time_frame>Day 49 to Day 56</time_frame>
        <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O2">
            <title>Seltorexant 10 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O3">
            <title>Seltorexant 20 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
          <group group_id="O4">
            <title>Seltorexant 40 mg</title>
            <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
          </group>
        </group_list>
        <measure>
          <title>Physician Withdrawal Checklist-20 (PWC-20) Total Score From Day 49 to Day 56</title>
          <description>Intensity of discontinuation symptoms was assessed (for example: underlying depression; anxiety-nervousness; dysphoric mood/depression; difficulty concentrating; weakness; fatigue-lethargy-lack of energy; irritability), using the Physician Withdrawal Checklist (PWC-20) administered by a trained clinician/rater. Symptoms are rated on a scale 0 (No symptom present) and 3 (severe symptoms). Total scores range from 0 to 24 calculated by adding the scores of following 8 items: Nausea-Vomiting, Diarrhea, Poor Coordination, Diaphoresis, Tremor-Tremulousness, Dizziness-Lightheadedness, Increased Acuity Sound Smell Touch, Paresthesias. Higher scores indicating more severe symptoms.</description>
          <population>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (numbers of participants analyzed) signifies numbers of participants evaluable for this outcome measure.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="133"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="57"/>
                <count group_id="O4" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="1.91"/>
                    <measurement group_id="O2" value="0.4" spread="0.78"/>
                    <measurement group_id="O3" value="0.8" spread="1.64"/>
                    <measurement group_id="O4" value="0.7" spread="1.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to Week 8</time_frame>
      <desc>Safety analyses set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants in the double-blind treatment period received seltorexant matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
        </group>
        <group group_id="E2">
          <title>Double-blind: Seltorexant 10 mg</title>
          <description>Participants in the double-blind treatment period received Seltorexant 10 milligrams (mg) capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
        </group>
        <group group_id="E3">
          <title>Double-blind: Seltorexant 20 mg</title>
          <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
        </group>
        <group group_id="E4">
          <title>DB: Seltorexant 40 mg</title>
          <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
        </group>
        <group group_id="E5">
          <title>Follow-up: Placebo</title>
          <description>Participants in the double-blind treatment period received matching placebo capsule once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
        </group>
        <group group_id="E6">
          <title>Follow-up: Seltorexant 10 mg</title>
          <description>Participants in the double-blind treatment period received seltorexant 10 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
        </group>
        <group group_id="E7">
          <title>Follow-up: Seltorexant 20 mg</title>
          <description>Participants in the double-blind treatment period received seltorexant 20 mg capsules once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
        </group>
        <group group_id="E8">
          <title>Follow-up: Seltorexant 40 mg</title>
          <description>Participants in the double-blind treatment period received seltorexant 40 mg capsules (2*20 mg capsules) once daily orally from Day 1 to Day 41 (Week 6). Participants had a follow-up visit within 7 to 14 days after double-blind treatment period. During the follow-up phase, participants were followed-up for the safety assessments on Day 43 (Week 7).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 21.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="137"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="137"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="137"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="137"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Polycythaemia Vera</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="137"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="137"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA Version 21.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="137"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="52"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="137"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="137"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="137"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="137"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="137"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="137"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="52"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="137"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="137"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="137"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="137"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="137"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>SENIOR DIRECTOR</name_or_title>
      <organization>Janssen Research &amp; Development, LLC</organization>
      <phone>844-434-4210</phone>
      <email>ClinicalTrialDisclosure@its.jnj.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03227224
org study id: CR108281
secondary id: 42847922MDD2001
secondary id: 2015-005282-22
nct id: NCT03227224
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to assess the dose-response relationship of 2 doses of
      JNJ-42847922 before interim analysis, and potentially 3 doses based on interim analysis
      results, compared to placebo as adjunctive therapy to an antidepressant drug in improving
      depressive symptoms in participants with Major Depressive Disorder (MDD) who have had an
      inadequate response to current antidepressant therapy with a selective serotonin reuptake
      inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI); and to assess the
      safety and tolerability of JNJ-42847922 compared to placebo as adjunctive therapy to an
      antidepressant in participants with MDD.
The study will investigate the antidepressant effects of a range of doses of JNJ-42847922
      (seltorexant) (versus placebo), as adjunctive treatment to antidepressant drugs for treatment
      of MDD, and will assess the safety and tolerability of JNJ-42847922. The study will be
      conducted in 3 phases: a screening phase (up to 4 weeks), a double-blind treatment phase (6
      weeks), and a post-treatment follow-up phase (2 weeks). Efficacy, safety, pharmacokinetic,
      and biomarker evaluations will be performed in the study at defined timepoints. The duration
      of the study will be up to approximately 12 weeks (84 days).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
time frame: Baseline to Week 6
description: MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score range of 0-60 which is calculated by adding the scores of all 10 items. Higher scores represent a more severe condition.
measure: Percentage of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
time frame: Up to Week 8
description: An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between the initial administration of study drug and 2 days after the last administration of study drug.
measure: Percentage of Participants With Clinically Significant Laboratory Abnormalities
time frame: Up to Week 8
description: Percentage of participants with clinically significant laboratory abnormalities were reported which included Gamma-glutamyl transferase (GGT), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Creatine Kinase (CK), Lactate Dehydrogenase (LDH), Albumin , bicarbonate, bilirubin, calcium, chloride, cholesterol, creatinine, direct bilirubin, glucose, high density lipoprotein (HDL) cholesterol, hemoglobin A1C, low density lipoprotein (LDL) cholesterol, phosphate, potassium, protein, sodium, triglycerides, urate, and urea nitrogen.
measure: Change From Baseline in Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) at Day 8
time frame: Baseline and Day 8
description: Change from baseline in vital signs (SBP and DBP) at Day 8 was reported.
measure: Change From Baseline in Vital Signs (SBP and DBP) at Day 22
time frame: Baseline and Day 22
description: Change from baseline in vital signs (SBP and DBP) at Day 22 was reported.
measure: Change From Baseline in Vital Signs (SBP and DBP) at Day 42
time frame: Baseline and Day 42
description: Change from baseline in vital signs (SBP and DBP) at Day 42 was reported.
measure: Change From Baseline in Vital Signs (SBP and DBP) at Endpoint (Week 6)
time frame: Baseline and Endpoint (Week 6)
description: Change from baseline in vital signs (SBP and DBP) at endpoint was reported.
measure: Change From Baseline in Vital Sign (Pulse Rate [PR]) at Day 8
time frame: Baseline and Day 8
description: Change from baseline in vital sign (PR) at Day 8 was reported.
measure: Change From Baseline in Vital Sign (PR) at Day 22
time frame: Baseline and Day 22
description: Change from baseline in vital sign (PR) at Day 22 was reported.
measure: Change From Baseline in Vital Sign (PR) at Day 42
time frame: Baseline and Day 42
description: Change from baseline in vital sign (PR) at Day 42 was reported.
measure: Change From Baseline in Vital Sign (PR) at Endpoint (Week 6)
time frame: Baseline and Endpoint (Week 6)
description: Change from baseline in vital sign (PR) at endpoint (Week 6) was reported.
measure: Change From Baseline in Vital Sign (Temperature) at Day 8
time frame: Baseline and Day 8
description: Change from baseline in vital Sign (temperature) at Day 8 was reported.
measure: Change From Baseline in Vital Sign (Temperature) at Day 22
time frame: Baseline and Day 22
description: Change from baseline in vital Sign (temperature) at Day 22 was reported.
measure: Change From Baseline in Vital Sign (Temperature) at Day 42
time frame: Baseline and Day 42
description: Change from baseline in vital Sign (temperature) at Day 42 was reported.
measure: Change From Baseline in Vital Sign (Temperature) at Endpoint (Week 6)
time frame: Baseline and Endpoint (Week 6)
description: Change from baseline in vital Sign (temperature) at endpoint (Week 6) was reported.
measure: Change From Baseline in Physical Examination (Waist Circumference) at Day 42
time frame: Baseline and Day 42
description: Change from baseline in physical examination (waist circumference) was reported.
measure: Change From Baseline in Physical Examination (Body Weight) at Day 42
time frame: Baseline and Day 42
description: Change from baseline in physical examination (body weight) was reported.
measure: Change From Baseline in Physical Examination (Body Mass Index [BMI]) at Day 42
time frame: Baseline and Day 42
description: Change from baseline in physical examination (BMI) was reported.
measure: Percentage of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values Outside Pre-defined Limits
time frame: Up to Week 6
description: Percentage of participants with treatment-emergent abnormal ECG values (Heart rate less than or equal to [<=] 50 or greater than or equal to [>=] 100 beats per minute [bpm], PR interval <=120 or >=200 milliseconds [msec], QRS interval <=60 or >=120 msec, and QT interval <=200 or >=500 msec) outside pre-defined limits were reported.
measure: Percentage of Participants With Most Severe Post-baseline Potentially Suicide-Related Category Using Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: Up to Week 8
description: C-SSRS is a clinician-rated instrument that reports severity of both suicidal ideation and behavior. Suicidal ideation was classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods [not plan] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. Minimum total score 0, maximum total score 5; higher total scores indicate more suicidal ideation and/or suicidal behavior. If no events qualify for score of 1 to 10, score of 0 was assigned (0= "no event that can be assessed on the basis of C-SSRS"). Higher scores indicate greater severity.
measure: Change From Baseline in Sexual Functioning as Measured by Arizona Sexual Experiences Scale (ASEX) Score at Day 42
time frame: Baseline and Day 42
description: Effect on sexual functioning was assessed using the ASEX score. The ASEX is a five-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Each of the 5 items is rated on a 6-point scale, ranging from 1 to 6. The 5 items are summed to create a total score, ranging from 5 to 30, with the higher scores indicating more sexual dysfunction.
measure: Physician Withdrawal Checklist-20 (PWC-20) Total Score at Day 43
time frame: Day 43
description: Intensity of discontinuation symptoms was assessed (for example: underlying depression; anxiety-nervousness; dysphoric mood/depression; difficulty concentrating; weakness; fatigue-lethargy-lack of energy; irritability), using the Physician Withdrawal Checklist (PWC-20) administered by a trained clinician/rater. Symptoms are rated on a scale 0 (No symptom present) and 3 (severe symptoms). Total scores range from 0 to 24 calculated by adding the scores of following 8 items: Nausea-Vomiting, Diarrhea, Poor Coordination, Diaphoresis, Tremor-Tremulousness, Dizziness-Lightheadedness, Increased Acuity Sound Smell Touch, Paresthesias. Higher scores indicating more severe symptoms.
measure: Physician Withdrawal Checklist-20 (PWC-20) Total Score From Day 49 to Day 56
time frame: Day 49 to Day 56
description: Intensity of discontinuation symptoms was assessed (for example: underlying depression; anxiety-nervousness; dysphoric mood/depression; difficulty concentrating; weakness; fatigue-lethargy-lack of energy; irritability), using the Physician Withdrawal Checklist (PWC-20) administered by a trained clinician/rater. Symptoms are rated on a scale 0 (No symptom present) and 3 (severe symptoms). Total scores range from 0 to 24 calculated by adding the scores of following 8 items: Nausea-Vomiting, Diarrhea, Poor Coordination, Diaphoresis, Tremor-Tremulousness, Dizziness-Lightheadedness, Increased Acuity Sound Smell Touch, Paresthesias. Higher scores indicating more severe symptoms.
measure: Change From Baseline in the MADRS Total Score by Baseline Insomnia Severity Index (ISI) Score at Day 42
time frame: Baseline and Day 42
description: MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score range of 0-60 which is calculated by adding the scores of all 10 items. Higher scores represent a more severe condition. The ISI has 7 questions, each rated on a 5-point Likert scale ranging from 0 to 4. The total score is calculated as the sum of the 7 items ranging from 0 to 28. Higher scores represent a more severe condition.
measure: Change From Baseline in ISI Total Score at DB Endpoint (Up to Week 6)
time frame: Baseline and DB Endpoint (Up to Week 6)
description: The ISI is a commonly used, 7-item psychometrically validated measure used to rate insomnia. Each item is scored 0 (no problem) to 4 (very big problem) with total between 0-28 which is calculated by adding the scores of all 7 items (absence of insomnia [0-7]; sub-threshold insomnia [8-14]; moderate insomnia [15-21]; and severe insomnia [22-28]). The change in ISI total score from baseline at DB endpoint was evaluated. Negative change in score indicates improvement.
measure: Percentage of Participants With Response on Depressive Symptoms Scale Based on MADRS Total Score
time frame: Day 42
description: Responders are defined as participants with a >=50 percent (%) improvement in the MADRS total score from baseline to a given timepoint. MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score range of 0-60 which is calculated by adding the scores of all 10 items. Higher scores represent a more severe condition. Participants with missing values at a given time point were imputed as non-responders.
measure: Percentage of Participants With Remission of Depressive Symptoms Based on MADRS Total Score
time frame: Day 42
description: Participants with a MADRS total score of less than or equal to (<=) 8, <=10, and <=12 at a given time point were considered as remitters. MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score range of 0-60 which is calculated by adding the scores of all 10 items. Higher scores represent a more severe condition. Participants with missing values at a given time point were imputed as non-responders.
measure: Change From Baseline in Structured Interview Guide for the Hamilton Anxiety Rating Scale (HAM-A) Total Score at Day 42
time frame: Baseline and Day 42
description: HAM-A is a 14-item scale designed to measure anxiety in individuals. Each question reflects a symptom of anxiety and physical as well as mental symptoms are represented. Each of the 14-items in the scale is scored on a 5-point scale, ranging from 0 (a complete lack of that symptom) to 4 (a very severe show of anxiety with that symptom). The total score ranges from 0 to 56 which is calculated by adding the scores of all 14 items, where 0-13 indicates normal range, 14-17 indicates mild severity, 18 -24: mild to moderate severity, 25 -30: moderate to severe, and >=31: severe. Higher score indicates worsening. Negative change in score indicates improvement.
measure: Percentage of Participants With Response on Anxiety Symptoms Scale Based on HAM-A Total Score
time frame: Day 42
description: Participants with a >=50 percent improvement in the HAM-A total score from baseline at a given timepoint were considered as responders. HAM-A is a 14-item scale designed to measure anxiety in individuals. Each question reflects a symptom of anxiety and physical as well as mental symptoms are represented. Each of the 14-items in the scale is scored on a 5-point scale, ranging from 0 (a complete lack of that symptom) to 4 (a very severe show of anxiety with that symptom). The total score ranges from 0 to 56 which is calculated by adding the scores of all 14 items, where 0-13 indicates normal range, 14-17 indicates mild severity, 18 -24: mild to moderate severity, 25 -30: moderate to severe, and >=31: severe. Higher score indicates worsening. Participants with missing values at a given time point were imputed as non-responders.
measure: Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at DB Endpoint (Up to Week 6)
time frame: Baseline and DB Endpoint (Up to Week 6)
description: The CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes into account all available information, including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S is a 7-point global assessment scale that measures the clinician's impression of the severity of illness exhibited by a participant, rating according to: 1=normal (not at all ill); 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7=among the most extremely ill participants. Higher scores indicate worsening. Negative change in score indicates improvement.
measure: Change From Baseline in the Sheehan Disability Scale (SDS) Score at Day 42
time frame: Baseline and Day 42
description: The SDS is a 5-item questionnaire which has been widely used and accepted for assessment of functional impairment and associated disability. The first 3 items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a 0-10 rating scale. The scores for the first 3 items are summed to create a total score of 0-30, where a higher score indicates greater impairment. It also has 1 item on days lost from school or work and 1 item on days when underproductive. Negative change in score indicates improvement.
measure: Change From Baseline in the MADRS Total Score at Day 42 in Participants With Major Depressive Disorder (MDD) With Anxious Distress Versus Participants With MDD Without Anxious Distress
time frame: Baseline and Day 42
description: MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score range of 0-60 which is calculated by adding the scores of all 10 items. Higher scores represent a more severe condition. Negative change in score indicates improvement.
measure: Change From Baseline in Salivary Cortisol Levels, Measured Upon Awakening at Days 8, 22 and 42
time frame: Baseline, Days 8, 22 and 42
description: Exposure on the hypothalamic-pituitary-adrenal (HPA) axis in participants with MDD was evaluated by assessing change in salivary cortisol levels.
measure: Plasma Concentrations of Seltorexant and Its Metabolites (M12 and M16)
time frame: Day 1: Between 0.25 hours (h) to 1.5 hour, 2 to 4 hours, and 6 to 8 hours post-dose; Day 8 (morning): 6 to 12 hours post evening dose of Day 7
description: Plasma concentrations of Seltorexant and its metabolites (M12 and M16) over time were reported.
measure: Change From Baseline in Depressive Symptoms Using the Patient Health Questionnaire 9-Item (PHQ-9) at DB Endpoint (Up to Week 6)
time frame: Baseline and DB Endpoint (Up to Week 6)
description: The PHQ-9 is a 9-item, Patient Reported Outcome (PRO) measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) major depressive disorder (MDD) criteria. Each item is rated on a 4 point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participants item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 is categorized as follows: None-minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19) and Severe (20-27).
measure: Change From Baseline in Anhedonia Using the Snaith-Hamilton Pleasure Scale (SHAPS) Score at DB Endpoint (Up to Week 6)
time frame: Baseline and DB Endpoint (Up to Week 6)
description: The SHAPS is a 14-item, self-report instrument to assess hedonic capacity in adults with MDD. Each of the items has a set of 4 response categories-Definitely Agree (=1), Agree (=2), Disagree (=3), and Definitely Disagree (=4). A total score is created with either of the Disagree responses receiving a score of 1 and either of the Agree responses receiving a score of 0. The participants item responses are summed to provide a total score ranging from 0 to 14. A higher total SHAPS score indicates higher levels of current anhedonia.
measure: Change From Baseline in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form at DB Endpoint (Up to Week 6)
time frame: Baseline and DB Endpoint (Up to Week 6)
description: The PROMIS-SD Short Form subscale consists of a static 8 item questionnaire. It assesses the concepts of sleep initiation (2 items), quality of sleep (3 items), early morning feelings (2 items) and worrying about sleep (1 item). Responses to each of the 8 items range from 1 to 5, and the range of possible summed raw scores is 8 to 40. Higher scores on the PROMIS-SD indicate more of the concept measured (disturbed sleep). Negative change in score indicates improvement.
measure: Change From Baseline in Fatigue Using the Patient Reported Outcome Measurement Information System-Fatigue (PROMIS-F) Short Form Subscale Score at DB Endpoint (Up to Week 6)
time frame: Baseline and DB Endpoint (Up to Week 6)
description: The PROMIS-Fatigue Short Form subscale consists of a static 8 item questionnaire. It assesses a range of symptoms from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Ratings are done on a 5-item Likert scale ranging from 0 (not at all) to 5 (very much) or 0 (never) to 5(always) depending upon the question answered. Higher scores on the PROMIS-F indicate more of the concept measured (fatigue). Negative change in score indicates improvement.
measure: Change From Baseline in Severity of Depression Using the Patient Global Impression-Severity (PGI-S) Score at DB Endpoint (Up to Week 6)
time frame: Baseline and DB Endpoint (Up to Week 6)
description: The PGI-S is a self-report scale to measure severity of illness (1=none, 2=mild, 3=moderate, 4=severe). Higher score indicates more illness severity. Negative change in score indicates improvement.
measure: Change From Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Heath State Index Total Score at DB Endpoint (Up to Week 6)
time frame: Baseline and DB Endpoint (Up to Week 6)
description: EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses to 5 EQ-5D-5L dimensions were scored using a utility-weighted algorithm to derive an EQ-5D-5L health status index score between 0 (death) to 100 (full health).
measure: Change From Baseline in EQ-5D-5L Visual Analog Scale (VAS) Total Score at Endpoint (Up to Week 6)
time frame: Baseline and Endpoint (up to Week 6)
description: The EQ-5D-5L is a standardized instrument for use as a measure of health outcome, primarily designed for self-completion by respondents. It consists of the EQ-5D-5L descriptive system and the EQ visual analogue scale (EQ-VAS). EQ-5D-5L (describing and valuing health-related quality of life) descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the participant's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. Higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. EQ-VAS self-rating records respondent's own assessment of his/her overall health status at time of completion, on scale of 0 (worst health you can imagine) to 100 (best health you can imagine).
measure: Change From Baseline in Work Productivity and Limitations Using the Work Limitations Questionnaire (WLQ) Short Form Score at DB Endpoint (Up to Week 6)
time frame: Baseline and DB Endpoint (Up to Week 6)
description: The WLQ is to assess the on-the-job impact of chronic health problems and/or treatment ("work limitations") in adults. It is a 8-item questionnaire self-report rating scale developed to measure the on-the-job impact of chronic health problems and/or treatment ("work limitations"). It comprises five dimensions of limitations: handling time, physical, mental-interpersonal, productivity loss and output demands. Participants respond to each item with options ranging from 'Almost all of the time' to 'none of the time', or 'Does not apply to my job'. Each dimension of limitations have a scale score ranging from 0 to 100 with lower score indicating low level of work limitations.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants will receive 2 placebo capsules matching JNJ-42847922 once daily orally from Day 1 to Day 41 (Week 6).
arm group label: JNJ-42847922
arm group type: Experimental
description: Participants will receive 2 capsules of JNJ-42847922 once daily orally from Day 1 to Day 41 (Week 6).
intervention type: Drug
intervention name: Placebo
description: Participants will receive 2 placebo capsules matching JNJ-42847922 once daily orally from Day 1 to Day 41 (Week 6).
arm group label: Placebo
intervention type: Drug
intervention name: JNJ-42847922
description: Participants will receive 2 capsules of JNJ-42847922 once daily orally from Day 1 to Day 41 (Week 6).
arm group label: JNJ-42847922
other name: MIN-202;
other name: Seltorexant
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Janssen Research & Development, LLC Clinical Trial
role: Study Director
affiliation: Janssen Research & Development, LLC
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country: Bulgaria
country: Finland
country: France
country: Germany
country: Japan
country: Russian Federation
country: Ukraine
country: United States
responsible party type: Sponsor
mesh term: Depressive Disorder
mesh term: Depression
mesh term: Depressive Disorder, Major
provided document: 
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reported events: 
certain agreements: 
point of contact: 