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Study of the Efficacy and Safety of LY2940094 in Participants With Major Depressive Disorder (MDD)

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ClinicalTrials.gov Identifier: NCT01724112
Recruitment Status : Completed
First Posted : November 9, 2012
Last Update Posted : February 3, 2017
Sponsor:
Information provided by (Responsible Party):
BlackThorn Therapeutics, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: LY2940094 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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)
Study Start Date : November 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: LY2940094
40 mg administered orally as 1 capsule QD for 8 weeks.
 Drug: LY2940094
Administered orally
Placebo Comparator: Placebo
Administered orally as 1 capsule QD for 8 weeks.
 Drug: Placebo
Administered orally


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Proportion of Participants Responding to Treatment [ Time Frame: Baseline through Week 8 ]
  2. Proportion of Participants who Achieved Remission [ Time Frame: Week 8 ]
  3. Change from Baseline to Week 8 in Maier-Philipp Subscale (MPS) Score [ Time Frame: Baseline,Week 8 ]
  4. Clinical Global Impression - Improvement (CGI-I) Score at Week 8 [ Time Frame: Week 8 ]
  5. Change from Baseline to Week 8 in the Clinical Global Impression - Severity (CGI-S) Score [ Time Frame: Baseline, Week 8 ]
  6. Change from Baseline to Week 4 in the Hamilton Anxiety Rating Scale (HAM-A) Total Score [ Time Frame: Baseline, Week 4 ]
  7. Change from Baseline to Week 8 in the Hospital Anxiety and Depression Scale (HADS) Score [ Time Frame: Baseline, Week 8 ]
  8. Population Pharmacokinetic (PK) Model: Estimate of LY2940094 Area Under the Curve (AUC) [ Time Frame: Baseline through 8 Weeks of Treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a diagnosis of MDD without psychotic features as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
  • Have clinically significant depressive symptoms defined by a GRID Hamilton Depression Rating Scale 17 (HAMD17) Total Score ≥20 at screening
  • Body mass index (BMI) between 18 and 35 kilogram per square meter (kg/m²)

Exclusion Criteria:

  • Have a current or previous diagnosis of bipolar I or II disorder, MDD with psychotic features, schizoaffective disorder, schizophrenia, or other psychotic disorder
  • Currently meeting the criteria of treatment-resistant depression defined as ≥2 documented, failed treatment trials of adequate dose and duration with a registered antidepressant during the current depressive episode
  • Had electroconvulsive treatment, transcranial magnetic stimulation, vagal nerve stimulation for symptoms of depression in the 6 months prior to screening
  • Have any clinically significant medical or uncontrolled condition or circumstance prior to randomization that could affect participant safety
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01724112


Locations
United States, Florida
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.
North Miami, Florida, United States, 33161
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.
Oakland Park, Florida, United States, 33334
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.
University Park, Florida, United States, 34201
United States, Kansas
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.
Prairie Village, Kansas, United States, 66206
United States, New Mexico
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.
Albuquerque, New Mexico, United States, 87109
United States, New York
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.
New York, New York, United States, 10021
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.
Staten Island, New York, United States, 10312
United States, Oregon
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.
Portland, Oregon, United States, 97210
United States, Utah
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.
Clinton, Utah, United States, 84015
United States, Washington
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.
Bellevue, Washington, United States, 98007
Sponsors and Collaborators
BlackThorn Therapeutics, Inc.
Investigators
Study Director: 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) Eli Lilly and Company
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: BlackThorn Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01724112     History of Changes
Other Study ID Numbers: 14791
I5J-MC-NOAC ( Other Identifier: Eli Lilly and Company )
First Posted: November 9, 2012    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
 Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms