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

Purpose

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	Intervention	Phase
Major Depressive Disorder	Drug: LY2940094 Drug: Placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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)

Further study details as provided by BlackThorn Therapeutics, Inc.:

Primary Outcome Measures:

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:

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 ]


Enrollment:	136
Study Start Date:	November 2012
Study Completion Date:	March 2014
Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


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 )
Study First Received:	October 31, 2012
Last Updated:	February 1, 2017

Additional relevant MeSH terms:


Disease Depressive Disorder Depression Depressive Disorder, Major	Pathologic Processes Mood Disorders Mental Disorders Behavioral Symptoms

ClinicalTrials.gov processed this record on May 25, 2017