Efficacy and Safety of Flexibly Dosed 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 in the treatment of patients with treatment resistant depression (TRD).

Key facts

Study ID

NCT01309945

Run by

Bristol-Myers Squibb

People needed

889

Starts

2011-04-01

Expected to finish

2013-01-01

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…

• 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.

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 at an adequate dose and for an adequate duration in their current episode unless in the judgment of the investigator, the patient could benefit from the treatment with this medication.
• Patients whose only inadequate response to an antidepressant in the current Major Depressive Episode (MDE) is to an Serotonin norepinephrine reuptake inhibitors (SNRI) (duloxetine, venlafaxine, desvenlafaxine or milnacipran).

Where it is running

• Pacific Clinical Research Medical Group — Arcadia, California, United States
• Pharmacology Research Institute — Encino, California, United States
• Collaborative Neuroscience Network, Inc. — Garden Grove, California, United States
• Pharmacology Research Institute — Los Alamitos, California, United States
• Pharmacology Research Institute — Newport Beach, California, United States
• California Neuropsychopharmacology Clinical Research Inst. — San Diego, California, United States
• Pacific Research Network, Inc — San Diego, California, United States
• California Neuroscience Research Medical Group, Inc. — Sherman Oaks, California, United States
• Schuster Medical Research Institute — Sherman Oaks, California, United States
• Pacific Clinical Research Medical Group — Upland, California, United States
• Radiant Research, Inc. — Denver, Colorado, United States
• Comprehensive Psychiatric Care — Norwich, Connecticut, United States
• Clinical Neuroscience Solutions, Inc. — Jacksonville, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Orlando, Florida, United States
• Compass Research, Llc — Orlando, Florida, United States
• Comprehensive Clinical Development, Inc. — St. Petersburg, Florida, United States
• Atlanta Institute Of Medicine & Research — Atlanta, Georgia, United States
• Comprehensive Clinical Development, Inc. — Atlanta, Georgia, United States
• Carman Research — Smyrna, Georgia, United States
• Loyola University Health System — Maywood, Illinois, United States
• Alpine Clinic — Lafayette, Indiana, United States
• Clinical Trials Technology, Inc — Prairie Village, Kansas, United States
• James G. Barbee, Md, Llc — New Orleans, Louisiana, United States
• SPRI Clinical Trials, LLC — Brooklyn, New York, United States
• K & S Professional Research Services, Llc — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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