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 |
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.
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.
We found this trial at
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Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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5601 Corporate Way
West Palm Beach, Florida 33407
West Palm Beach, Florida 33407
561-238-3036
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McLean Hospital McLean Hospital is a comprehensive psychiatric hospital committed to providing easy access to...
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Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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