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

This study has been terminated.
(Failure to meet primary endpoint)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01361555
First Posted: May 27, 2011
Last Update Posted: October 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
  Purpose
The purpose of this study it to evaluate the long-term safety and tolerability of BMS-820836 in patients with depression.

Condition Intervention Phase
Depression Drug: Placebo matching with BMS-820836 Drug: BMS-820836 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, 58 Week Rollover Study to Assess the Safety and Tolerability of BMS-820836 in Patients With Treatment Resistant Major Depression

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Long-term effects of BMS-820836 on blood pressure in patients with depression [ Time Frame: Baseline through Week 54 ]

Secondary Outcome Measures:
  • • Adverse Events (AEs), Serious Adverse Events, and Discontinuations Due to AEs [ Time Frame: Baseline through Week 54 ]

Enrollment: 789
Study Start Date: August 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Placebo + BMS-820836 (0.5 mg/day) 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
Experimental: Arm 2: Placebo + BMS-820836 (1 mg/day) Drug: Placebo matching with BMS-820836
Tablet, Oral, 0.0 mg, Once daily, 54 weeks
Drug: BMS-820836
Tablet, Oral, 1.0 mg, Once daily, 54 weeks
Experimental: Arm 3: Placebo + BMS-820836 (2 mg/day) Drug: Placebo matching with BMS-820836
Tablet, Oral, 0.0 mg, Once daily, 54 weeks
Drug: BMS-820836
Tablet, Oral, 2.0 mg, Once daily, 54 weeks

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01361555


  Show 144 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01361555     History of Changes
Other Study ID Numbers: CN162-010
2010-024371-12 ( EudraCT Number )
First Submitted: May 25, 2011
First Posted: May 27, 2011
Last Update Posted: October 12, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders