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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01361555
First received: May 25, 2011
Last updated: November 4, 2013
Last verified: November 2013
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01361555

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

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01361555     History of Changes
Other Study ID Numbers: CN162-010, 2010-024371-12
Study First Received: May 25, 2011
Last Updated: November 4, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Sweden: Medical Products Agency
Finland: Finnish Medicines Agency
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes
South Africa: Medicines Control Council
South Africa: Department of Health
Germany: Federal Institute for Drugs and Medical Devices
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Office for Safety in Health Care
Spain: Spanish Agency of Medicines
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on October 23, 2014