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

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

Official Title
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A Multicenter, Double-Blind, 58 Week Rollover Study to Assess the Safety and Tolerability of BMS-820836 in Patients With Treatment Resistant Major Depression

Conditions
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Depression

Intervention / Treatment
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* Drug: Placebo matching with BMS-820836
* Drug: BMS-820836
* Drug: BMS-820836
* Drug: BMS-820836


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Placebo + BMS-820836 (0.5 mg/day)<br> | Drug: Placebo matching with BMS-820836<br>* Tablet, Oral, 0.0 mg, Once daily, 54 weeks<br>Drug: BMS-820836<br>* Tablet, Oral, 0.5 mg, Once daily, 54 weeks<br>|
| Experimental: Arm 2: Placebo + BMS-820836 (1 mg/day)<br> | Drug: Placebo matching with BMS-820836<br>* Tablet, Oral, 0.0 mg, Once daily, 54 weeks<br>Drug: BMS-820836<br>* Tablet, Oral, 1.0 mg, Once daily, 54 weeks<br>|
| Experimental: Arm 3: Placebo + BMS-820836 (2 mg/day)<br> | Drug: Placebo matching with BMS-820836<br>* Tablet, Oral, 0.0 mg, Once daily, 54 weeks<br>Drug: BMS-820836<br>* Tablet, Oral, 2.0 mg, Once daily, 54 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term effects of BMS-820836 on blood pressure in patients with depression |  | Baseline through Week 54 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Adverse Events (AEs), Serious Adverse Events, and Discontinuations Due to AEs |  | Baseline through Week 54 |