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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Depression

In brief

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

Key facts

Study ID

NCT01361555

Run by

Bristol-Myers Squibb

People needed

789

Starts

2011-08-01

Expected to finish

2013-10-01

Last updated by the study team

2015-10-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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 — Arcadia, California, United States
• Catalina Research Institute, Llc — Chino, California, United States
• Pharmacology Research Institute — Encino, California, United States
• Collaborative Neuroscience Network, Inc. — Garden Grove, California, United States
• Behavioral Research Specialists, Llc — Glendale, California, United States
• Pharmacology Research Institute — Los Alamitos, California, United States
• Pharmacology Research Institute — Newport Beach, California, United States
• Neuropsychiatric Research Center Of Orange County — Orange, California, United States
• Pacific Clinical Research Medical Group — Orange, California, United States
• Anderson Clinical Research — Redlands, California, United States
• California Neuropsychopharmacology Clinical — San Diego, California, United States
• Pacific Research Network — San Diego, California, United States
• Affiliated Research Institute — San Diego, California, United States
• Artemis Institute For Clinical Research — San Diego, California, United States
• Sharp Mesa Vista Hospital — San Diego, California, United States
• California Neuroscience Research Medical Group, Inc. — Sherman Oaks, California, United States
• Schuster Medical Research Institute — Sherman Oaks, California, United States
• Pacific Clinical Research Medical Group — Upland, California, United States
• Western Affiliated Research Institute — Denver, Colorado, United States
• Radiant Research, Inc. — Denver, Colorado, United States
• Connecticut Clinical Research — Cromwell, Connecticut, United States
• Meridien Research — Brooksville, Florida, United States
• Birmingham Psychiatry Pharmaceutical Studies, Inc. — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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