Long-term Safety and Tolerability of BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2

Conditions: Depression

Treatments: Drug: Placebo matching with BMS-820836; Drug: BMS-820836

Study type: Interventional

Funder types: Industry

Identifiers

NCT01361555

2010-024371-12 (EudraCT Number)

CN162-010

Details and patient eligibility

About

The purpose of this study it to evaluate the long-term safety and tolerability of BMS-820836 in patients with depression.

Enrollment: 789 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women of age 18-65 years (Argentina the minimum age will be 24 years of age)
• Patients randomized in parent study who complete CN162-006 and CN162-007 who consent to enter the rollover study.
• Patient not randomized in parent study that meet inadequate response criteria

Exclusion criteria

• Patients who represent a significant risk of committing suicide based on the clinical judgment of the investigator, history or routine psychiatric status exam.
• Patients with a Cardiovascular System Organ Class adverse event(s) occurring in parent study (CN162-006 or CN162-007), that in the investigators judgment is clinically significant and would impact safety of the subject in the current study [including but not limited to left bundle branch block, or prolonged QT interval corrected (QTc)].
• In addition, patients should be excluded if they have any laboratory test, vital sign, electrocardiogram (ECG) or clinical findings that in the investigator's judgment is clinically significantly abnormal and could impact the safety of the patient or the interpretation of study assessments in the current study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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789 participants in 3 patient groups

Arm 1: Placebo + BMS-820836 (0.5 mg/day)

Experimental group

Treatment:

Drug: Placebo matching with BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Arm 2: Placebo + BMS-820836 (1 mg/day)

Experimental group

Treatment:

Drug: Placebo matching with BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Arm 3: Placebo + BMS-820836 (2 mg/day)

Experimental group

Treatment:

Drug: Placebo matching with BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836