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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01361555
Other study ID # CN162-010
Secondary ID 2010-024371-12
Status Terminated
Phase Phase 2
First received May 25, 2011
Last updated September 23, 2015
Start date August 2011
Est. completion date October 2013

Study information

Verified date September 2015
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review BoardSweden: Medical Products AgencyFinland: Finnish Medicines AgencyCanada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of PersonnesSouth Africa: Medicines Control CouncilSouth Africa: Department of HealthGermany: Federal Institute for Drugs and Medical DevicesAustralia: Department of Health and Ageing Therapeutic Goods AdministrationAustria: Federal Office for Safety in Health CareSpain: Spanish Agency of MedicinesArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaBrazil: National Health Surveillance AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Terminated
Enrollment 789
Est. completion date October 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

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


Intervention

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

Locations

Country Name City State
Argentina Local Institution Caba Buenos Aires
Argentina Local Institution Caba Buenos Aires
Argentina Local Institution Cordoba
Argentina Local Institution Cordoba
Argentina Local Institution La Plata Buenos Aires
Argentina Local Institution Mendoza
Australia Local Institution Adelaide South Australia
Australia Local Institution Brisbane Queensland
Australia Local Institution Heidelberg Victoria
Australia Local Institution Nedlands Western Australia
Austria Local Institution Wien
Austria Local Institution Wien
Finland Local Institution Helsinki
Finland Local Institution Helsinki
Finland Local Institution Jarvenpaa
Finland Local Institution Oulu
Finland Local Institution Seinajoki
Finland Local Institution Tampere
Finland Local Institution Turku
France Local Institution Dole
France Local Institution Douai
France Local Institution Elancourt
France Local Institution Jonzac
France Local Institution Limoges Cedex
France Local Institution Montpellier Cedex 5
France Local Institution Paris
India Local Institution Ahmedabad Gujarat
India Local Institution Chennai
India Local Institution Mumbai Maharashtra
India Local Institution Pune Maharashtra
India Local Institution Pune
India Local Institution Varanasi
India Local Institution Vishakapattanam
Italy Local Institution Pisa
Italy Local Institution Siena
Puerto Rico Local Institution Ponce
South Africa Local Institution Cape Town Western Cape
South Africa Local Institution Durban Kwa Zulu Natal
South Africa Local Institution Johannesburg Gauteng
South Africa Local Institution Pretoria Gauteng
South Africa Local Institution Pretoria Gauteng
South Africa Local Institution Pretoria Gauteng
Spain Local Institution Arganda Del Rey
Spain Local Institution Barcelona
Spain Local Institution Barcelona
Spain Local Institution Madrid
Sweden Local Institution Halmstad
Sweden Local Institution Kungens Kurva
Sweden Local Institution Lund
Sweden Local Institution Uppsala
United States Albuquerque Neuroscience, Inc. Albuquerque New Mexico
United States Lehigh Center For Clinical Research Allentown Pennsylvania
United States Pacific Clinical Research Medical Group Arcadia California
United States Atlanta Institute Of Medicine & Research Atlanta Georgia
United States Comprehensive Clinical Development, Inc Atlanta Georgia
United States Emory University Atlanta Georgia
United States Community Clinical Research, Inc. Austin Texas
United States Futuresearch Trials Austin Texas
United States Northcoast Clinical Trials, Inc Beachwood Ohio
United States Northwest Clinical Research Center Bellevue Washington
United States Mclean Hospital Belmont Massachusetts
United States Birmingham Psychiatry Pharmaceutical Studies, Inc. Birmingham Alabama
United States Spri Clinical Trials, Llc Brooklyn New York
United States Meridien Research Brooksville Florida
United States Northbrooke Research Center Brown Deer Wisconsin
United States Neurobehavioral Research, Inc. Cedarhurst New York
United States Carolinas Healthcare System Charlotte North Carolina
United States Catalina Research Institute, Llc Chino California
United States Patient Priority Clinical Sites, Llc Cincinnati Ohio
United States Ericksen Research And Development Clinton Utah
United States Carolina Clinical Research Services Columbia South Carolina
United States Connecticut Clinical Research Cromwell Connecticut
United States Futuresearch Trials Of Dallas Dallas Texas
United States Midwest Clinical Research Center Dayton Ohio
United States Radiant Research, Inc. Denver Colorado
United States Western Affiliated Research Institute Denver Colorado
United States Pharmacology Research Institute Encino California
United States Gulfcoast Clinical Research Center Fort Myers Florida
United States Psychiatric Consultants, Pc Franklin Tennessee
United States Collaborative Neuroscience Network, Inc. Garden Grove California
United States Behavioral Research Specialists, Llc Glendale California
United States Baylor College Of Medicine Houston Texas
United States Red Oak Psychiatry Associates, Pa Houston Texas
United States Ut Health-Houston Houston Texas
United States Amit Vijapura Jacksonville Florida
United States Clinical Neuroscience Solutions, Inc. Jacksonville Florida
United States Comprehensive Clinical Development, Inc Jamaica New York
United States Alpine Clinic Lafayette Indiana
United States Lincoln Research Lincoln Rhode Island
United States Arkansas Psychiatric Clinic Clinical Research Trials, P.A. Little Rock Arkansas
United States K & S Professional Research Services, Llc Little Rock Arkansas
United States Pharmacology Research Institute Los Alamitos California
United States Loyola University Medical Center Maywood Illinois
United States Suburban Research Associates Media Pennsylvania
United States Clinical Neuroscience Solutions, Inc. Memphis Tennessee
United States Dean Foundation For Health Research & Education Middleton Wisconsin
United States Radiant Research, Inc. Murray Utah
United States James G. Barbee, Md, Llc New Orleans Louisiana
United States Village Clinical Research, Inc. New York New York
United States Pharmacology Research Institute Newport Beach California
United States Keystone Clinical Studies, Llc Norristown Pennsylvania
United States Ips Research Company Oklahoma City Oklahoma
United States Neuropsychiatric Research Center Of Orange County Orange California
United States Pacific Clinical Research Medical Group Orange California
United States Clinical Neuroscience Solutions, Inc. Orlando Florida
United States Compass Research, Llc Orlando Florida
United States Thomas Jefferson University Philadelphia Pennsylvania
United States Univ Of Penn Philadelphia Pennsylvania
United States University Of Pennsylvania Philadelphia Pennsylvania
United States University Of Pennsylvania Philadelphia Pennsylvania
United States Bioscience Research, Llc Pittsburgh Pennsylvania
United States Comprehensive Psychiatric Care Pittsburgh Pennsylvania
United States Insite Clinical Research Pittsburgh Pennsylvania
United States Oregon Center For Clinical Investigations, Inc. (Occi, Inc) Portland Oregon
United States Summit Research Network (Oregon) Inc Portland Oregon
United States Clinical Trials Technology, Inc Prairie Village Kansas
United States Richard H. Weisler, Md, Pa & Assoc. Raleigh North Carolina
United States Anderson Clinical Research Redlands California
United States Finger Lakes Clinical Research Rochester New York
United States Comprehensive Clinical Development, Inc. Saint Petersburg Florida
United States Oregon Center For Clinical Investigations, Inc (Occi, Inc) Salem Oregon
United States Lifetree Clinical Research Salt Lake City Utah
United States Psychiatric And Behavioral Solutions Salt Lake City Utah
United States San Antonio Psychiatric Research Center San Antonio Texas
United States Affiliated Research Institute San Diego California
United States Artemis Institute For Clinical Research San Diego California
United States California Neuropsychopharmacology Clinical San Diego California
United States Pacific Research Network San Diego California
United States Sharp Mesa Vista Hospital San Diego California
United States Summit Research Network (Seattle) Llc Seattle Washington
United States California Neuroscience Research Medical Group, Inc. Sherman Oaks California
United States Schuster Medical Research Institute Sherman Oaks California
United States J. Gary Booker, Md, Apmc Shreveport Louisiana
United States Carman Research Smyrna Georgia
United States Stedman Clinical Trials Tampa Florida
United States Clinco Terre Haute Indiana
United States Neurology & Neuroscience Center Of Ohio Toledo Ohio
United States Bio Behavioral Health Toms River New Jersey
United States Tulsa Clinical Research, Llc Tulsa Oklahoma
United States Pacific Clinical Research Medical Group Upland California
United States Independent Psychiatric Consultants, Sc, Dba, Ipc Research Waukesha Wisconsin
United States Janus Center For Psychiatric Research West Palm Beach Florida
United States Grayline Clinical Drug Trials Wichita Falls Texas
United States Neuropsychiatric Associates Woodstock Vermont

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Finland,  France,  India,  Italy,  Puerto Rico,  South Africa,  Spain,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Long-term effects of BMS-820836 on blood pressure in patients with depression Baseline through Week 54 No
Secondary • Adverse Events (AEs), Serious Adverse Events, and Discontinuations Due to AEs Baseline through Week 54 Yes
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