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

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ClinicalTrials.gov Identifier: NCT01361555
Recruitment Status : Terminated (Failure to meet primary endpoint)
First Posted : May 27, 2011
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE May 25, 2011
First Posted Date  ICMJE May 27, 2011
Last Update Posted Date October 12, 2015
Study Start Date  ICMJE August 2011
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2015)
Long-term effects of BMS-820836 on blood pressure in patients with depression [ Time Frame: Baseline through Week 54 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 25, 2011)
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 ]
Change History Complete list of historical versions of study NCT01361555 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2015)
• Adverse Events (AEs), Serious Adverse Events, and Discontinuations Due to AEs [ Time Frame: Baseline through Week 54 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2011)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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 Arms  ICMJE
  • 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 Terminated
Actual Enrollment  ICMJE
 (submitted: November 4, 2013)
789
Original Estimated Enrollment  ICMJE
 (submitted: May 25, 2011)
900
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Finland,   France,   India,   Italy,   Puerto Rico,   South Africa,   Spain,   Sweden,   United States
Removed Location Countries Brazil,   Canada,   Germany,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT01361555
Other Study ID Numbers  ICMJE CN162-010
2010-024371-12 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date September 2015

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