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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Depression

Treatments: Drug: Duloxetine; Drug: BMS-820836; Drug: BMS-820836 Placebo; Drug: Escitalopram

Study type: Interventional

Funder types: Industry

Identifiers

NCT01369095

2011-000778-71 (EudraCT Number)

CN162-007

Details and patient eligibility

About

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).

Enrollment: 976 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

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 and Escitalopram at an adequate dose and for an adequate duration in their current episode.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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976 participants in 5 patient groups

Arm 1: Duloxetine / Escitalopram + BMS-820836 placebo

Active Comparator group

Treatment:

Drug: Duloxetine

Drug: Escitalopram

Drug: BMS-820836 Placebo

Arm 2: BMS-820836 (0.25 mg) + BMS-820836 placebo

Experimental group

Treatment:

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836 Placebo

Drug: BMS-820836

Drug: BMS-820836

Arm 3: BMS-820836 (0.50 mg) + BMS-820836 placebo

Experimental group

Treatment:

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836 Placebo

Drug: BMS-820836

Drug: BMS-820836

Arm 4: BMS-820836 (1.0 mg) + BMS-820836 placebo

Experimental group

Treatment:

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836 Placebo

Drug: BMS-820836

Drug: BMS-820836

Arm 5: BMS-820836 (2.0 mg) + BMS-820836 placebo

Experimental group

Treatment:

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836 Placebo

Drug: BMS-820836

Drug: BMS-820836