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

February 1, 2017 updated by: BlackThorn Therapeutics, Inc.

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • 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
        • 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.
    • Kansas
      • Prairie Village, Kansas, United States, 66206
        • 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 Mexico
      • Albuquerque, New Mexico, United States, 87109
        • 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, 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
        • 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.
    • Oregon
      • Portland, Oregon, United States, 97210
        • 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.
    • Utah
      • Clinton, Utah, United States, 84015
        • 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.
    • Washington
      • Bellevue, Washington, United States, 98007
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline, Week 8

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BlackThorn Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ACTUAL)

March 1, 2014

Study Registration Dates

First Submitted

October 31, 2012

First Submitted That Met QC Criteria

November 6, 2012

First Posted (ESTIMATE)

November 9, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 3, 2017

Last Update Submitted That Met QC Criteria

February 1, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14791
  • I5J-MC-NOAC (OTHER: Eli Lilly and Company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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