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



Status:Terminated
Conditions:Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:August 2011
End Date:October 2013

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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

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


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.
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Jacksonville, Florida 32216
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201 Dowman Dr
Atlanta, Georgia 30303
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100 West Gore St # 202
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3838 South 700 East
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901 Boren Avenue
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1000 Regency Court
Toledo, Ohio 43623
419-841-7369
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West Palm Beach, Florida 33407
561-238-3036
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2160 South 1st Avenue
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