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Long-term Safety and Tolerabi...

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

Last Updated: 2015-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

789 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-10-31

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.

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Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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

Group Type EXPERIMENTAL

Placebo matching with BMS-820836

Intervention Type DRUG

Tablet, Oral, 0.0 mg, Once daily, 54 weeks

BMS-820836

Intervention Type DRUG

Tablet, Oral, 0.5 mg, Once daily, 54 weeks

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

Group Type EXPERIMENTAL

Placebo matching with BMS-820836

Intervention Type DRUG

Tablet, Oral, 0.0 mg, Once daily, 54 weeks

BMS-820836

Intervention Type DRUG

Tablet, Oral, 1.0 mg, Once daily, 54 weeks

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

Group Type EXPERIMENTAL

Placebo matching with BMS-820836

Intervention Type DRUG

Tablet, Oral, 0.0 mg, Once daily, 54 weeks

BMS-820836

Intervention Type DRUG

Tablet, Oral, 2.0 mg, Once daily, 54 weeks

Interventions

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Placebo matching with BMS-820836

Tablet, Oral, 0.0 mg, Once daily, 54 weeks

Intervention Type DRUG

BMS-820836

Tablet, Oral, 0.5 mg, Once daily, 54 weeks

Intervention Type DRUG

BMS-820836

Tablet, Oral, 1.0 mg, Once daily, 54 weeks

Intervention Type DRUG

BMS-820836

Tablet, Oral, 2.0 mg, Once daily, 54 weeks

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Birmingham Psychiatry Pharmaceutical Studies, Inc.

Birmingham, Alabama, United States

Site Status

K & S Professional Research Services, Llc

Little Rock, Arkansas, United States

Site Status

Arkansas Psychiatric Clinic Clinical Research Trials, P.A.

Little Rock, Arkansas, United States

Site Status

Pacific Clinical Research Medical Group

Arcadia, California, United States

Site Status

Catalina Research Institute, Llc

Chino, California, United States

Site Status

Pharmacology Research Institute

Encino, California, United States

Site Status

Collaborative Neuroscience Network, Inc.

Garden Grove, California, United States

Site Status

Behavioral Research Specialists, Llc

Glendale, California, United States

Site Status

Pharmacology Research Institute

Los Alamitos, California, United States

Site Status

Pharmacology Research Institute

Newport Beach, California, United States

Site Status

Neuropsychiatric Research Center Of Orange County

Orange, California, United States

Site Status

Pacific Clinical Research Medical Group

Orange, California, United States

Site Status