xml: <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/NCT06029426</url>
    </required_header>
    <id_info>
      <org_study_id>NMRA-335140-301</org_study_id>
      <secondary_id>KOASTAL-1</secondary_id>
      <nct_id>NCT06029426</nct_id>
    </id_info>
    <brief_title>Study to Evaluate the Effects of Oral NMRA 335140 Versus Placebo in Participants With Major Depressive Disorder</brief_title>
    <official_title>A Phase 3, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Effects of Oral NMRA 335140 Versus Placebo in Participants With Major Depressive Disorder</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Neumora Therapeutics, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Neumora Therapeutics, Inc.</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>
        This is a randomized, double blind, placebo controlled, multicenter study to evaluate the&#xD;
        effects of NMRA 335140 (formerly BTRX 335140) on symptoms of depression in participants with&#xD;
        Major Depressive Disorder (MDD). The study design consists of a Screening Period (up to 28&#xD;
        days), and a 6-week Treatment Period (during which participants will receive either NMRA&#xD;
        335140 or placebo). At the completion of the 6-week Treatment Period, participants who&#xD;
        complete the study, provide informed consent, and meet the eligibility criteria may enter an&#xD;
        extension study (NMRA 335140 501).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">July 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
    <phase>Phase 3</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>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change from Baseline to Week 6 in the Montgomery Asberg Depression Rating Scale (MADRS) total score</measure>
      <time_frame>Baseline and up to Week 6</time_frame>
      <description>The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants are rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item will be scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. Thus, scores in the MADRS range from 0 to 60, with increasing scores indicating increasing severity.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline to Week 6 assessed in the Snaith-Hamilton Pleasure Scale (SHAPS) total score</measure>
      <time_frame>Baseline and up to Week 6</time_frame>
      <description>The SHAPS is a 14 item participant-reported instrument which measures anhedonia. It has been shown to be valid and reliable in normal and clinical samples, with adequate construct validity, satisfactory test-retest reliability and high internal consistency. The scale will be completed by the participant and reviewed by site personnel qualified to oversee completeness. Each of the 14 items has a set of 4 responses, 2 of which endorse agreement (Definitely Agree, Agree) and 2 of which endorse disagreement (Disagree, Strongly Disagree). A total score can be derived by summing the response items, where those answered with &quot;strongly agree&quot; will be coded as a 1, while a &quot;strongly disagree&quot; response will be coded as 4. Therefore, scores on the SHAPS can range from 14 to 56, with higher scores corresponding to higher levels of anhedonia.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">332</enrollment>
    <condition>Major Depressive Disorder</condition>
    <arm_group>
      <arm_group_label>NMRA-335140 80 milligrams (mg) once daily (QD)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive a NMRA- 335140 tablet at a dose of 80 mg once daily (QD)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo participants will receive matching placebo tablet orally, once daily. Participants who complete the study may be eligible to participate in a separate 52-week open-label long term study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>NMRA 335140</intervention_name>
      <description>Participants will receive NMRA-335140 at a dose of 80 mg QD, orally</description>
      <arm_group_label>NMRA-335140 80 milligrams (mg) once daily (QD)</arm_group_label>
      <other_name>BTRX 335140</other_name>
      <other_name>CYM-53093</other_name>
      <other_name>Navacaprant</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo will be administered orally</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Key inclusion criteria:&#xD;
  &#xD;
            -  Have a primary Diagnostic and Statistical Manual of Mental Disorders Fifth Edition&#xD;
               Text Revised (DSM-5-TR) diagnosis of MDD without psychotic features confirmed by&#xD;
               Structured Clinical Interview for DSM 5 Disorders, Clinical Trials Version (SCID 5 CT)&#xD;
               at screening (this may be a first or recurrent episode).&#xD;
  &#xD;
            -  Participant's current major depressive episode must be confirmed by independent&#xD;
               assessment.&#xD;
  &#xD;
            -  The symptoms of the current MDD episode have been present for more than 4 weeks prior&#xD;
               to the Screening Visit, but no longer than 12 months prior to the Screening Visit.&#xD;
  &#xD;
            -  Have a MADRS total score of 25 or higher at Screening and Baseline.&#xD;
  &#xD;
            -  A change in MADRS total score between Screening and Baseline of ≤20%.&#xD;
  &#xD;
          Key exclusion criteria:&#xD;
  &#xD;
            -  Have failed 2 or more courses of antidepressant treatment for the current MDD episode.&#xD;
  &#xD;
            -  Have currently or in the past year any of the following DSM-5-TR disorders:&#xD;
               personality disorder, anorexia nervosa, bulimia nervosa, or binge eating disorder.&#xD;
               Participants with comorbid generalized anxiety disorder, social anxiety disorder,&#xD;
               simple phobias, or panic disorder for whom MDD is considered the primary diagnosis are&#xD;
               not excluded.&#xD;
  &#xD;
            -  Have a lifetime diagnosis of bipolar 1 or 2, schizophrenia, obsessive compulsive&#xD;
               disorder, or post traumatic stress disorder (PTSD).&#xD;
  &#xD;
            -  Have moderate to severe substance or alcohol use disorder, per DSM-5-TR criteria,&#xD;
               within the 12 months prior to screening (excluding nicotine).&#xD;
  &#xD;
            -  Are actively suicidal (e.g., any suicide attempts within the past 12 months) or are at&#xD;
               serious suicidal risk as indicated by any current suicidal intent, including a plan,&#xD;
               as assessed by the Columbia Suicide Severity Rating Scale (C SSRS) (score of &quot;YES&quot; on&#xD;
               suicidal ideation Item 4 or 5 within 3 months prior to Visit 1 [screening]) and/or&#xD;
               based on clinical evaluation by the Investigator; or are homicidal, in the opinion of&#xD;
               the Investigator.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Study Contact</last_name>
      <email>Clinicaltrials@neumoratx.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Major Depressive Disorder</keyword>
    <keyword>NMRA-335140</keyword>
    <keyword>Placebo-controlled</keyword>
    <keyword>Double-blind</keyword>
    <keyword>Navacaprant</keyword>
    <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>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06029426
  org study id: NMRA-335140-301
  secondary id: KOASTAL-1
  nct id: NCT06029426
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  This is a randomized, double blind, placebo controlled, multicenter study to evaluate the
        effects of NMRA 335140 (formerly BTRX 335140) on symptoms of depression in participants with
        Major Depressive Disorder (MDD). The study design consists of a Screening Period (up to 28
        days), and a 6-week Treatment Period (during which participants will receive either NMRA
        335140 or placebo). At the completion of the 6-week Treatment Period, participants who
        complete the study, provide informed consent, and meet the eligibility criteria may enter an
        extension study (NMRA 335140 501).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Change from Baseline to Week 6 in the Montgomery Asberg Depression Rating Scale (MADRS) total score
  time frame: Baseline and up to Week 6
  description: The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants are rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item will be scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. Thus, scores in the MADRS range from 0 to 60, with increasing scores indicating increasing severity.
  measure: Change from Baseline to Week 6 assessed in the Snaith-Hamilton Pleasure Scale (SHAPS) total score
  time frame: Baseline and up to Week 6
  description: The SHAPS is a 14 item participant-reported instrument which measures anhedonia. It has been shown to be valid and reliable in normal and clinical samples, with adequate construct validity, satisfactory test-retest reliability and high internal consistency. The scale will be completed by the participant and reviewed by site personnel qualified to oversee completeness. Each of the 14 items has a set of 4 responses, 2 of which endorse agreement (Definitely Agree, Agree) and 2 of which endorse disagreement (Disagree, Strongly Disagree). A total score can be derived by summing the response items, where those answered with "strongly agree" will be coded as a 1, while a "strongly disagree" response will be coded as 4. Therefore, scores on the SHAPS can range from 14 to 56, with higher scores corresponding to higher levels of anhedonia.
  arm group label: NMRA-335140 80 milligrams (mg) once daily (QD)
  arm group type: Experimental
  description: Participants will receive a NMRA- 335140 tablet at a dose of 80 mg once daily (QD)
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Placebo participants will receive matching placebo tablet orally, once daily. Participants who complete the study may be eligible to participate in a separate 52-week open-label long term study.
  intervention type: Drug
  intervention name: NMRA 335140
  description: Participants will receive NMRA-335140 at a dose of 80 mg QD, orally
  arm group label: NMRA-335140 80 milligrams (mg) once daily (QD)
  other name: BTRX 335140
  other name: CYM-53093
  other name: Navacaprant
  intervention type: Drug
  intervention name: Placebo
  description: Placebo will be administered orally
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Study Contact
  email: Clinicaltrials@neumoratx.com
  responsible party type: Sponsor
  mesh term: Depressive Disorder
  mesh term: Depression
  mesh term: Depressive Disorder, Major
  sharing ipd: No