Efficacy and Safety of Flexibly Dosed BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression

Phase 2

Completed

Interventions: Drug: Placebo matching with Duloxetine
Drug: Duloxetine
Drug: Placebo matching with BMS-820836
Drug: BMS-820836

Brief Summary: 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).

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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).

Arm && Interventions

Group	Intervention	Description
Arm 5: Duloxetine placebo	Placebo matching with Duloxetine	-
Arm 4: Duloxetine 30mg	Duloxetine	-
Arm 1: Duloxetine 30mg	Duloxetine	-
Arm 2: BMS-820836 placebo	Placebo matching with BMS-820836	-
Arm 3: BMS-820836 0.5-2.0 mg/day	BMS-820836	-

Primary Outcome Measures

Name	Time	Method
Change in Montgomery Asberg Depression Rating Scale (MADRS) total score	End of phase B and End of phase C

Secondary Outcome Measures

Name	Time	Method
Change in Sheehan Disability Scale (SDS) Total score	End of Phase B and End of Phase C
Change in the Montgomery Asberg Depression Rating Scale (MADRS) anhedonia factor score	End of Phase B and End of Phase C

Locations (48): K & S Professional Research Services, Llc
🇺🇸
Little Rock, Arkansas, United States
Pacific Clinical Research Medical Group
🇺🇸
Upland, California, United States
Pharmacology Research Institute
🇺🇸
Newport Beach, California, United States
Collaborative Neuroscience Network, Inc.
🇺🇸
Garden Grove, 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
Radiant Research, Inc.
🇺🇸
Murray, Utah, United States
Comprehensive Psychiatric Care
🇺🇸
Norwich, Connecticut, United States
Scroll for more (38 remaining)
K & S Professional Research Services, Llc
🇺🇸Little Rock, Arkansas, United States