Efficacy and Safety of Fixed Doses of BMS 820836 in the Treatment of Patients With Treatment Resistant Major Depression
- Conditions
- Depression
- Interventions
- Registration Number
- NCT01369095
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of the study is to evaluate the efficacy of study drug (BMS-820836) as compared with continued Duloxetine/Escitalopram in the treatment of patients with treatment resistant depression (TRD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 976
- Men and women of age 18-65 years (Argentina minimum age will be 24 years of age)
- Patients must be able to understand the nature of the study, agree to comply with the prescribed dosage regimens, report for regularly scheduled office visits, and communicate to study personnel about adverse events and concomitant medication use.
- Patients with a diagnosis of Major Depressive Disorder, currently experiencing a Major Depressive Episode, as defined by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (Text Revision)[DSM IV TR] criteria. The current depressive episode must be > 8 weeks in duration and < 3 years duration.
- In the current Major depressive disorder (MDD) episode, patients should report a history of inadequate response to 1-3 adequate trials of antidepressant treatment.
- Patients must have a 17-item Hamilton Depression Rating Scale (HAM-D17) total score ≥ 18 at Screening and Baseline.
- Patients who report an inadequate response (less than 50% reduction in depressive symptom severity) to more than three adequate trials of antidepressant treatments during the current depressive episode.
- Patients who have failed Duloxetine and Escitalopram at an adequate dose and for an adequate duration in their current episode.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 5: BMS-820836 (2.0 mg) + BMS-820836 placebo BMS-820836 - Arm 1: Duloxetine / Escitalopram + BMS-820836 placebo Duloxetine - Arm 1: Duloxetine / Escitalopram + BMS-820836 placebo Escitalopram - Arm 1: Duloxetine / Escitalopram + BMS-820836 placebo BMS-820836 Placebo - Arm 2: BMS-820836 (0.25 mg) + BMS-820836 placebo BMS-820836 Placebo - Arm 2: BMS-820836 (0.25 mg) + BMS-820836 placebo BMS-820836 - Arm 3: BMS-820836 (0.50 mg) + BMS-820836 placebo BMS-820836 - Arm 4: BMS-820836 (1.0 mg) + BMS-820836 placebo BMS-820836 - Arm 5: BMS-820836 (2.0 mg) + BMS-820836 placebo BMS-820836 Placebo - Arm 3: BMS-820836 (0.50 mg) + BMS-820836 placebo BMS-820836 Placebo - Arm 4: BMS-820836 (1.0 mg) + BMS-820836 placebo BMS-820836 Placebo -
- Primary Outcome Measures
Name Time Method Change from baseline to endpoint in the Montgomery Asberg Depression Rating Scale (MADRS) total score Week 13
- Secondary Outcome Measures
Name Time Method Change from baseline to endpoint in mean Sheehan Disability Scale (SDS) score. Week 13
Trial Locations
- Locations (48)
Mclean Hospital
🇺🇸Belmont, Massachusetts, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Pacific Clinical Research Medical Group
🇺🇸Orange, California, United States
Insite Clinical Research
🇺🇸Desoto, Texas, United States
Keystone Clinical Studies, Llc
🇺🇸Norristown, Pennsylvania, United States
Amit Vijapura
🇺🇸Jacksonville, Florida, United States
Local Institution
🇬🇧Birmingham, West Midlands, United Kingdom
Behavioral Research Specialists, Llc
🇺🇸Glendale, California, United States
Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
🇺🇸Little Rock, Arkansas, United States
Suburban Research Associates
🇺🇸Media, Pennsylvania, United States
Clinco
🇺🇸Terre Haute, Indiana, United States
Grayline Clinical Drug Trials
🇺🇸Wichita Falls, Texas, United States
Neuropsychiatric Associates
🇺🇸Woodstock, Vermont, United States
Future Search Trials
🇺🇸Austin, Texas, United States
Lincoln Research
🇺🇸Lincoln, Rhode Island, United States
Ericksen Research And Development
🇺🇸Clinton, Utah, United States
Northcoast Clinical Trials, Inc
🇺🇸Beachwood, Ohio, United States
Neurology & Neuroscience Center Of Ohio
🇺🇸Toledo, Ohio, United States
Village Clinical Research, Inc.
🇺🇸New York, New York, United States
Meridien Research
🇺🇸Brooksville, Florida, United States
Clinical Trials Technology, Inc
🇺🇸Prairie Village, Kansas, United States
Birmingham Psychiatry Pharmaceutical Studies, Inc.
🇺🇸Birmingham, Alabama, United States
Artemis Institute For Clinical Research
🇺🇸San Diego, California, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Sharp Mesa Vista Hospital
🇺🇸San Diego, California, United States
Connecticut Clinical Research
🇺🇸Cromwell, Connecticut, United States
Janus Center For Psychiatric Research
🇺🇸West Palm Beach, Florida, United States
Gulfcoast Clinical Research Center
🇺🇸Fort Myers, Florida, United States
Uptown Research Institute, Llc
🇺🇸Chicago, Illinois, United States
Ert
🇺🇸Pittsburgh, Pennsylvania, United States
Comprehensive Clinical Development, Inc
🇺🇸Fresh Meadows, New York, United States
Patient Priority Clinical Sites, Llc
🇺🇸Cincinnati, Ohio, United States
Neuropsychiatric Research Center Of Orange County
🇺🇸Pittsburgh, Pennsylvania, United States
Northwest Clinical Research Center
🇺🇸Pittsburgh, Pennsylvania, United States
Futuresearch Trials Of Dallas
🇺🇸Dallas, Texas, United States
Ben Taub General Hospital
🇺🇸Houston, Texas, United States
Western Affiliated Research Institute
🇺🇸Denver, Colorado, United States
Stedman Clinical Trials
🇺🇸Tampa, Florida, United States
Affiliated Research Institute
🇺🇸San Diego, California, United States
Bioscience Research, Llc
🇺🇸Mount Kisco, New York, United States
Neuroscience, Inc
🇺🇸Herndon, Virginia, United States
Dean Foundation For Health Research & Education
🇺🇸Middleton, Wisconsin, United States
Summit Research Network (Seattle) Llc
🇺🇸Seattle, Washington, United States
Albuquerque Neuroscience, Inc.
🇺🇸Albuquerque, New Mexico, United States
Catalina Research Institute, Llc
🇺🇸Chino, California, United States
Anderson Clinical Research
🇺🇸Redlands, California, United States
Clinical Methods Llc
🇺🇸Murray, Utah, United States
Bio Behavioral Health
🇺🇸Toms River, New Jersey, United States