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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
976
Capsule, Oral, 30-60mg/day, once daily, 7 weeks (Phase B), 7weeks (Phase C\&D)
Capsule, Oral, 10-20 mg/day, once daily, 7 weeks (Phase B), 7 weeks (Phase C\&D)
Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B\&C)
Change from baseline to endpoint in the Montgomery Asberg Depression Rating Scale (MADRS) total score
Time frame: Week 13
Change from baseline to endpoint in mean Sheehan Disability Scale (SDS) score.
Time frame: Week 13
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Tablet, Oral, 0.25mg, once daily, 6 weeks (Phase C)
Tablet, Oral, 0.5 mg, once daily, 6 weeks (Phase C)
Tablet, Oral, 1.0 mg, once daily, 6 weeks (Phase C)
Tablet, Oral, 2.0 mg, once daily, 6 weeks (Phase C)
Birmingham Psychiatry Pharmaceutical Studies, Inc.
Birmingham, Alabama, United States
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
...and 83 more locations