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

Phase 2

Terminated

• Conditions: Depression
• Interventions: Drug: Placebo matching with BMS-820836; Drug: BMS-820836

• Registration Number: NCT01361555
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-25
• Study First Submitted QC: 2011-05-25
• Study First Posted: 2011-05-27
• Study Start: 2011-08
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2015-09
• Disposition First Submitted: 2015-09-23
• Disposition First Submitted QC: 2015-09-23
• Last Update Submitted: 2015-09-23
• Disposition First Posted: 2015-10-12
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 789

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 3: Placebo + BMS-820836 (2 mg/day)	BMS-820836	-
Arm 1: Placebo + BMS-820836 (0.5 mg/day)	Placebo matching with BMS-820836	-
Arm 2: Placebo + BMS-820836 (1 mg/day)	Placebo matching with BMS-820836	-
Arm 2: Placebo + BMS-820836 (1 mg/day)	BMS-820836	-
Arm 3: Placebo + BMS-820836 (2 mg/day)	Placebo matching with BMS-820836	-
Arm 1: Placebo + BMS-820836 (0.5 mg/day)	BMS-820836	-

Primary Outcome Measures

Name	Time	Method
Long-term effects of BMS-820836 on blood pressure in patients with depression	Baseline through Week 54

Secondary Outcome Measures

Name	Time	Method
• Adverse Events (AEs), Serious Adverse Events, and Discontinuations Due to AEs	Baseline through Week 54

Trial Locations

Locations (86)

Birmingham Psychiatry Pharmaceutical Studies, Inc.; 🇺🇸 Birmingham, Alabama, United States

K & S Professional Research Services, Llc; 🇺🇸 Little Rock, Arkansas, United States

Arkansas Psychiatric Clinic Clinical Research Trials, P.A.; 🇺🇸 Little Rock, Arkansas, United States

Pacific Clinical Research Medical Group; 🇺🇸 Upland, California, United States

Catalina Research Institute, Llc; 🇺🇸 Chino, California, United States

Pharmacology Research Institute; 🇺🇸 Newport Beach, California, United States

Collaborative Neuroscience Network, Inc.; 🇺🇸 Garden Grove, California, United States

Behavioral Research Specialists, Llc; 🇺🇸 Glendale, California, United States

Neuropsychiatric Research Center Of Orange County; 🇺🇸 Orange, California, United States

Anderson Clinical Research; 🇺🇸 Redlands, California, United States

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