A Phase 2 interventional study of Duloxetine and Placebo matching with BMS-820836 in Depression, sponsored by Bristol-Myers Squibb. Completed at 84 sites in 6 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-10-12.
Sponsored by Bristol-Myers Squibb · Phase 2, Interventional, and Treatment
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).
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 889 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Duloxetine
Drug: Placebo matching with BMS-820836
Drug: BMS-820836
Drug: Duloxetine
Drug: Placebo matching with Duloxetine
Capsule, Oral, 30-60 mg/day, once daily (QD), 8 weeks
Also known as: Cymbalta
Tablet, Oral, 0.0 mg, once daily (QD), 14 weeks
Tablet, Oral, 0.5-2.0 mg, once daily (QD), 6 weeks
Capsule, Oral, 30-60 mg/day, once daily (QD), 6 weeks
Also known as: Cymbalta
Tablet, Oral, 0.0 mg, once daily (QD), 8 weeks
Change in Montgomery Asberg Depression Rating Scale (MADRS) total score
Time frame: End of phase B and End of phase C
Change in Sheehan Disability Scale (SDS) Total score
Time frame: End of Phase B and End of Phase C
Change in the Montgomery Asberg Depression Rating Scale (MADRS) anhedonia factor score
Time frame: End of Phase B and End of Phase C
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Bristol-Myers Squibb