<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/NCT01724112</url>
  </required_header>
  <id_info>
    <org_study_id>14791</org_study_id>
    <secondary_id>I5J-MC-NOAC</secondary_id>
    <nct_id>NCT01724112</nct_id>
  </id_info>
  <brief_title>Study of the Efficacy and Safety of LY2940094 in Participants With Major Depressive Disorder (MDD)</brief_title>
  <official_title>8-Week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy and Safety of LY2940094 Administered Once Daily in Patients With Major Depressive Disorder (MDD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BlackThorn Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BlackThorn Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will determine the efficacy, safety, and tolerability of a 40 milligrams (mg)&#xD;
      once-daily (QD) dose of LY2940094 for 8 weeks in participants with MDD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline to Week 8 on the GRID Hamilton Depression Rating Scale 17 Item Version (GRID-HAMD17) Total Score</measure>
    <time_frame>Baseline, Week 8</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants Responding to Treatment</measure>
    <time_frame>Baseline through Week 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants who Achieved Remission</measure>
    <time_frame>Week 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline to Week 8 in Maier-Philipp Subscale (MPS) Score</measure>
    <time_frame>Baseline,Week 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression - Improvement (CGI-I) Score at Week 8</measure>
    <time_frame>Week 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline to Week 8 in the Clinical Global Impression - Severity (CGI-S) Score</measure>
    <time_frame>Baseline, Week 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline to Week 4 in the Hamilton Anxiety Rating Scale (HAM-A) Total Score</measure>
    <time_frame>Baseline, Week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline to Week 8 in the Hospital Anxiety and Depression Scale (HADS) Score</measure>
    <time_frame>Baseline, Week 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Population Pharmacokinetic (PK) Model: Estimate of LY2940094 Area Under the Curve (AUC)</measure>
    <time_frame>Baseline through 8 Weeks of Treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">136</enrollment>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>LY2940094</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>40 mg administered orally as 1 capsule QD for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Administered orally as 1 capsule QD for 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY2940094</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>LY2940094</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a diagnosis of MDD without psychotic features as defined in the Diagnostic and&#xD;
             Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)&#xD;
&#xD;
          -  Have clinically significant depressive symptoms defined by a GRID Hamilton Depression&#xD;
             Rating Scale 17 (HAMD17) Total Score ≥20 at screening&#xD;
&#xD;
          -  Body mass index (BMI) between 18 and 35 kilogram per square meter (kg/m²)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have a current or previous diagnosis of bipolar I or II disorder, MDD with psychotic&#xD;
             features, schizoaffective disorder, schizophrenia, or other psychotic disorder&#xD;
&#xD;
          -  Currently meeting the criteria of treatment-resistant depression defined as ≥2&#xD;
             documented, failed treatment trials of adequate dose and duration with a registered&#xD;
             antidepressant during the current depressive episode&#xD;
&#xD;
          -  Had electroconvulsive treatment, transcranial magnetic stimulation, vagal nerve&#xD;
             stimulation for symptoms of depression in the 6 months prior to screening&#xD;
&#xD;
          -  Have any clinically significant medical or uncontrolled condition or circumstance&#xD;
             prior to randomization that could affect participant safety&#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_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>North Miami</city>
        <state>Florida</state>
        <zip>33161</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Oakland Park</city>
        <state>Florida</state>
        <zip>33334</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>University Park</city>
        <state>Florida</state>
        <zip>34201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Prairie Village</city>
        <state>Kansas</state>
        <zip>66206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Staten Island</city>
        <state>New York</state>
        <zip>10312</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Clinton</city>
        <state>Utah</state>
        <zip>84015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 9, 2012</study_first_posted>
  <disposition_first_submitted>April 14, 2014</disposition_first_submitted>
  <disposition_first_submitted_qc>April 14, 2014</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">May 7, 2014</disposition_first_posted>
  <last_update_submitted>February 1, 2017</last_update_submitted>
  <last_update_submitted_qc>February 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 3, 2017</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>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT01724112
org study id: 14791
secondary id: I5J-MC-NOAC
nct id: NCT01724112
lead sponsor: 
has dmc: No
This study will determine the efficacy, safety, and tolerability of a 40 milligrams (mg)
      once-daily (QD) dose of LY2940094 for 8 weeks in participants with MDD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Change from Baseline to Week 8 on the GRID Hamilton Depression Rating Scale 17 Item Version (GRID-HAMD17) Total Score
time frame: Baseline, Week 8
measure: Proportion of Participants Responding to Treatment
time frame: Baseline through Week 8
measure: Proportion of Participants who Achieved Remission
time frame: Week 8
measure: Change from Baseline to Week 8 in Maier-Philipp Subscale (MPS) Score
time frame: Baseline,Week 8
measure: Clinical Global Impression - Improvement (CGI-I) Score at Week 8
time frame: Week 8
measure: Change from Baseline to Week 8 in the Clinical Global Impression - Severity (CGI-S) Score
time frame: Baseline, Week 8
measure: Change from Baseline to Week 4 in the Hamilton Anxiety Rating Scale (HAM-A) Total Score
time frame: Baseline, Week 4
measure: Change from Baseline to Week 8 in the Hospital Anxiety and Depression Scale (HADS) Score
time frame: Baseline, Week 8
measure: Population Pharmacokinetic (PK) Model: Estimate of LY2940094 Area Under the Curve (AUC)
time frame: Baseline through 8 Weeks of Treatment
arm group label: LY2940094
arm group type: Experimental
description: 40 mg administered orally as 1 capsule QD for 8 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: Administered orally as 1 capsule QD for 8 weeks.
intervention type: Drug
intervention name: LY2940094
description: Administered orally
arm group label: LY2940094
intervention type: Drug
intervention name: Placebo
description: Administered orally
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Depressive Disorder
mesh term: Depression
mesh term: Depressive Disorder, Major