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 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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 Eli Lilly and Company:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of Participants Responding to Treatment [ Time Frame: Baseline through Week 8 ] [ Designated as safety issue: No ]
Proportion of Participants who Achieved Remission [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Change from Baseline to Week 8 in Maier-Philipp Subscale (MPS) Score [ Time Frame: Baseline,Week 8 ] [ Designated as safety issue: No ]
Clinical Global Impression - Improvement (CGI-I) Score at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Change from Baseline to Week 8 in the Clinical Global Impression - Severity (CGI-S) Score [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
Change from Baseline to Week 4 in the Hamilton Anxiety Rating Scale (HAM-A) Total Score [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
Change from Baseline to Week 8 in the Hospital Anxiety and Depression Scale (HADS) Score [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
Population Pharmacokinetic (PK) Model: Estimate of LY2940094 Area Under the Curve (AUC) [ Time Frame: Baseline through 8 Weeks of Treatment ] [ Designated as safety issue: No ]


Estimated Enrollment:	120
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 milligram (mg) administered orally by capsule once daily for 8 weeks.	Drug: LY2940094 Administered orally
Placebo Comparator: Placebo Administered orally by one capsule once daily for 8 weeks.	Drug: Placebo Administered orally

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Have a diagnosis of Major Depressive Disorder (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 HAMD17 Total score ≥20 at screening
Body mass index (BMI) between 18 and 35 kilogram per square meter (kg/m^2)

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

Eli Lilly and Company

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:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01724112 History of Changes
Other Study ID Numbers:	14791 I5J-MC-NOAC
Study First Received:	October 31, 2012
Last Updated:	April 14, 2014
Health Authority:	United States: Food and Drug Administration

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 September 26, 2016