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

This study is currently recruiting participants.

Verified July 2011 by Bristol-Myers Squibb

Sponsor:

Information provided by (Responsible Party):

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT01361555

First received: May 25, 2011

Last updated: April 30, 2012

Last verified: July 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

May 25, 2011

Last Updated Date

April 30, 2012

Start Date ^ICMJE

August 2011

Estimated Primary Completion Date

August 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary endpoint for this study is to compare the long-term effect of BMS-820836 though 54 weeks in the change from baseline in blood pressure for patients with depression [ Time Frame: 54 Weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01361555 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Frequency and severity of Adverse Events (AE), frequency of Serious Adverse Events and discontinuations due to AEs. [ Time Frame: From randomization baseline through 54 weeks of the Rollover study ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Multicenter, Double-Blind, 58 Week Rollover Study to Assess the Safety and Tolerability of BMS-820836 in Patients With Treatment Resistant Major Depression

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Depression

Intervention ^ICMJE

Drug: Placebo matching with BMS-820836
Tablet, Oral, 0.0 mg, Once daily, 54 weeks
Drug: BMS-820836
Tablet, Oral, 0.5 mg, Once daily, 54 weeks
Drug: BMS-820836
Tablet, Oral, 1.0 mg, Once daily, 54 weeks
Drug: BMS-820836
Tablet, Oral, 2.0 mg, Once daily, 54 weeks

Study Arm (s)

Experimental: Arm 1: Placebo + BMS-820836 (0.5 mg/day)
Interventions:
- Drug: Placebo matching with BMS-820836
- Drug: BMS-820836
Experimental: Arm 2: Placebo + BMS-820836 (1 mg/day)
Interventions:
- Drug: Placebo matching with BMS-820836
- Drug: BMS-820836
Experimental: Arm 3: Placebo + BMS-820836 (2 mg/day)
Interventions:
- Drug: Placebo matching with BMS-820836
- Drug: BMS-820836

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

900

Estimated Completion Date

August 2014

Estimated Primary Completion Date

August 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Location Countries ^ICMJE

United States, Australia, Austria, Brazil, Finland, France, Germany, India, Italy, Puerto Rico, South Africa, Spain, Sweden, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01361555

Other Study ID Numbers ^ICMJE

CN162-010, 2010-024371-12

Has Data Monitoring Committee

Yes

Responsible Party

Bristol-Myers Squibb

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

July 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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