Efficacy and Safety of Fixed Doses of BMS 820836 in the Treatment of Patients With Treatment Resistant Major Depression

Completed · Phase 2 · Has a placebo group

Conditions studied: Depression

In brief

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).

Key facts

Study ID

NCT01369095

Run by

Bristol-Myers Squibb

People needed

976

Starts

2011-07-01

Expected to finish

2013-05-01

Last updated by the study team

2015-10-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Arkansas Psychiatric Clinic Clinical Research Trials, P.A. — Little Rock, Arkansas, United States
• Catalina Research Institute, Llc — Chino, California, United States
• Behavioral Research Specialists, Llc — Glendale, California, United States
• Pacific Clinical Research Medical Group — Orange, California, United States
• Anderson Clinical Research — Redlands, California, United States
• Affiliated Research Institute — San Diego, California, United States
• Artemis Institute For Clinical Research — San Diego, California, United States
• Sharp Mesa Vista Hospital — San Diego, California, United States
• Western Affiliated Research Institute — Denver, Colorado, United States
• Connecticut Clinical Research — Cromwell, Connecticut, United States
• Meridien Research — Brooksville, Florida, United States
• Gulfcoast Clinical Research Center — Fort Myers, Florida, United States
• Amit Vijapura — Jacksonville, Florida, United States
• Stedman Clinical Trials — Tampa, Florida, United States
• Janus Center For Psychiatric Research — West Palm Beach, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Uptown Research Institute, Llc — Chicago, Illinois, United States
• Clinco — Terre Haute, Indiana, United States
• Clinical Trials Technology, Inc — Prairie Village, Kansas, United States
• Ert — Shreveport, Louisiana, United States
• Mclean Hospital — Belmont, Massachusetts, United States
• Bio Behavioral Health — Toms River, New Jersey, United States
• Albuquerque Neuroscience, Inc. — Albuquerque, New Mexico, United States
• Comprehensive Clinical Development, Inc — Fresh Meadows, New York, United States
• Birmingham Psychiatry Pharmaceutical Studies, Inc. — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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