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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE October 31, 2012
First Posted Date  ICMJE November 9, 2012
Last Update Posted Date February 3, 2017
Study Start Date  ICMJE November 2012
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2012)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2012)
  • Proportion of Participants Responding to Treatment [ Time Frame: Baseline through Week 8 ]
  • Proportion of Participants who Achieved Remission [ Time Frame: Week 8 ]
  • Change from Baseline to Week 8 in Maier-Philipp Subscale (MPS) Score [ Time Frame: Baseline,Week 8 ]
  • Clinical Global Impression - Improvement (CGI-I) Score at Week 8 [ Time Frame: Week 8 ]
  • Change from Baseline to Week 8 in the Clinical Global Impression - Severity (CGI-S) Score [ Time Frame: Baseline, Week 8 ]
  • Change from Baseline to Week 4 in the Hamilton Anxiety Rating Scale (HAM-A) Total Score [ Time Frame: Baseline, Week 4 ]
  • Change from Baseline to Week 8 in the Hospital Anxiety and Depression Scale (HADS) Score [ Time Frame: Baseline, Week 8 ]
  • Population Pharmacokinetic (PK) Model: Estimate of LY2940094 Area Under the Curve (AUC) [ Time Frame: Baseline through 8 Weeks of Treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Efficacy and Safety of LY2940094 in Participants With Major Depressive Disorder (MDD)
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: LY2940094
    Administered orally
  • Drug: Placebo
    Administered orally
Study Arms  ICMJE
  • Experimental: LY2940094
    40 mg administered orally as 1 capsule QD for 8 weeks.
    Intervention: Drug: LY2940094
  • Placebo Comparator: Placebo
    Administered orally as 1 capsule QD for 8 weeks.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 1, 2017)
136
Original Estimated Enrollment  ICMJE
 (submitted: November 6, 2012)
120
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01724112
Other Study ID Numbers  ICMJE 14791
I5J-MC-NOAC ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party BlackThorn Therapeutics, Inc.
Study Sponsor  ICMJE BlackThorn Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account BlackThorn Therapeutics, Inc.
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP