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

Last updated: September 23, 2015
Sponsor: Bristol-Myers Squibb
Overall Status: Terminated

Phase

2

Condition

Depression

Treatment

N/A

Clinical Study ID

NCT01361555
CN162-010
2010-024371-12
  • Ages 18-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 consentto enter the rollover study.

  • Patient not randomized in parent study that meet inadequate response criteria

Exclusion

Exclusion Criteria:

  • Patients who represent a significant risk of committing suicide based on the clinicaljudgment of the investigator, history or routine psychiatric status exam.

  • Patients with a Cardiovascular System Organ Class adverse event(s) occurring in parentstudy (CN162-006 or CN162-007), that in the investigators judgment is clinicallysignificant and would impact safety of the subject in the current study [including butnot 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 isclinically significantly abnormal and could impact the safety of the patient or theinterpretation of study assessments in the current study.

Study Design

Total Participants: 789
Study Start date:
August 01, 2011
Estimated Completion Date:
October 31, 2013

Connect with a study center

  • Local Institution

    Caba, Buenos Aires 1405
    Argentina

    Site Not Available

  • Local Institution

    La Plata, Buenos Aires 1900
    Argentina

    Site Not Available

  • Local Institution

    Cordoba, 5003
    Argentina

    Site Not Available

  • Local Institution

    Mendoza, 5500
    Argentina

    Site Not Available

  • Local Institution

    Brisbane, Queensland 4000
    Australia

    Site Not Available

  • Local Institution

    Adelaide, South Australia 5112
    Australia

    Site Not Available

  • Local Institution

    Heidelberg, Victoria 3084
    Australia

    Site Not Available

  • Local Institution

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Local Institution

    Wien, 1090
    Austria

    Site Not Available

  • Local Institution

    Belo Horizonte, Minas Gerais 30150
    Brazil

    Site Not Available

  • Local Institution

    Curitiba, Parana 80240
    Brazil

    Site Not Available

  • Local Institution

    Botucatu, Sao Paulo 18618
    Brazil

    Site Not Available

  • Local Institution

    Itapira, Sao Paulo 13970
    Brazil

    Site Not Available

  • Local Institution

    Rio De Janeiro, Sao Paulo 22270
    Brazil

    Site Not Available

  • Local Institution

    Sao Paulo, 05403
    Brazil

    Site Not Available

  • Local Institution

    Helsinki, 00100
    Finland

    Site Not Available

  • Local Institution

    Jarvenpaa, 04400
    Finland

    Site Not Available

  • Local Institution

    Oulu, 90100
    Finland

    Site Not Available

  • Local Institution

    Seinajoki, 60100
    Finland

    Site Not Available

  • Local Institution

    Tampere, 33200
    Finland

    Site Not Available

  • Local Institution

    Turku, 20100
    Finland

    Site Not Available

  • Local Institution

    Dole, 39108
    France

    Site Not Available

  • Local Institution

    Douai, 59500
    France

    Site Not Available

  • Local Institution

    Elancourt, 78990
    France

    Site Not Available

  • Local Institution

    Jonzac, 17503
    France

    Site Not Available

  • Local Institution

    Limoges Cedex, 87025
    France

    Site Not Available

  • Local Institution

    Montpellier, 34295
    France

    Site Not Available

  • Local Institution

    Montpellier Cedex 5, 34295
    France

    Site Not Available

  • Local Institution

    Nimes, 30900
    France

    Site Not Available

  • Local Institution

    Paris, 75012
    France

    Site Not Available

  • Local Institution

    Strasbourg, 67100
    France

    Site Not Available

  • Local Institution

    Berlin, 10117
    Germany

    Site Not Available

  • Local Institution

    Ellwangen, 73479
    Germany

    Site Not Available

  • Local Institution

    Mittweida, 09648
    Germany

    Site Not Available

  • Local Institution

    Muenster, 48149
    Germany

    Site Not Available

  • Local Institution

    Ostfildern, 73760
    Germany

    Site Not Available

  • Local Institution

    Wuerzburg, 97070
    Germany

    Site Not Available

  • Local Institution

    Tirupati, Andhra Pradesh 517 507
    India

    Site Not Available

  • Local Institution

    Visakhapatnam, Andhra Pradesh 530002
    India

    Site Not Available

  • Local Institution

    Ahmedabad, Gujarat 380 006
    India

    Site Not Available

  • Local Institution

    Mumbai, Maharashtra 400012
    India

    Site Not Available

  • Local Institution

    Lucknow, Uttar Pradesh 226006
    India

    Site Not Available

  • Local Institution

    Chennai, 600116
    India

    Site Not Available

  • Local Institution

    Madurai, 625020
    India

    Site Not Available

  • Local Institution

    Pune, 411030
    India

    Site Not Available

  • Local Institution

    Varanasi, 211 005
    India

    Site Not Available

  • Local Institution

    Vishakapattanam, 530002
    India

    Site Not Available

  • Local Institution

    Bologna, 40133
    Italy

    Site Not Available

  • Local Institution

    Pisa, 56100
    Italy

    Site Not Available

  • Local Institution

    Roma, 00168
    Italy

    Site Not Available

  • Local Institution

    Siena, 53100
    Italy

    Site Not Available

  • Local Institution

    Ponce, 00730
    Puerto Rico

    Site Not Available

  • Local Institution

    Bloemfontein, Free State 9301
    South Africa

    Site Not Available

  • Local Institution

    Johannesburg, Gauteng 2195
    South Africa

    Site Not Available

  • Local Institution

    Pretoria, Gauteng 0187
    South Africa

    Site Not Available

  • Local Institution

    Vereeniging, Gauteng 1939
    South Africa

    Site Not Available

  • Local Institution

    Durban, Kwa Zulu Natal 3630
    South Africa

    Site Not Available

  • Local Institution

    Bellville, Western Cape 7535
    South Africa

    Site Not Available

  • Local Institution

    Cape Town, Western Cape 7530
    South Africa

    Site Not Available

  • Local Institution

    Somerset West, Western Cape 7130
    South Africa

    Site Not Available

  • Local Institution

    Arganda Del Rey, 28500
    Spain

    Site Not Available

  • Local Institution

    Barcelona, 08003
    Spain

    Site Not Available

  • Local Institution

    Madrid, 28006
    Spain

    Site Not Available

  • Local Institution

    Halmstad, 302 48
    Sweden

    Site Not Available

  • Local Institution

    Kungens Kurva, 14175
    Sweden

    Site Not Available

  • Local Institution

    Lund, 22222
    Sweden

    Site Not Available

  • Local Institution

    Malmo, 211 52
    Sweden

    Site Not Available

  • Local Institution

    Stockholm, 111 64
    Sweden

    Site Not Available

  • Local Institution

    Uppsala, 751 85
    Sweden

    Site Not Available

  • Local Institution

    London, Greater London W6 8RP
    United Kingdom

    Site Not Available

  • Local Institution

    Barnet, Hertfordshire EN5 3DJ
    United Kingdom

    Site Not Available

  • Local Institution

    Aberdare, Mid Glamorgan CF44 7AA
    United Kingdom

    Site Not Available

  • Local Institution

    Edgware, Middlesex HA8 0AD
    United Kingdom

    Site Not Available

  • Local Institution

    Oxford, Oxfordshire OX3 7JX
    United Kingdom

    Site Not Available

  • Local Institution

    Trowbridge, Wiltshire BA14 9AR
    United Kingdom

    Site Not Available

  • Birmingham Psychiatry Pharmaceutical Studies, Inc.

    Birmingham, Alabama 35226
    United States

    Site Not Available

  • Arkansas Psychiatric Clinic Clinical Research Trials, P.A.

    Little Rock, Arkansas 72223
    United States

    Site Not Available

  • K & S Professional Research Services, Llc

    Little Rock, Arkansas 72201
    United States

    Site Not Available

  • Pacific Clinical Research Medical Group

    Arcadia, California 91007
    United States

    Site Not Available

  • Local Institution

    Beverly Hills, California 90210
    United States

    Site Not Available

  • Catalina Research Institute, Llc

    Chino, California 91710
    United States

    Site Not Available

  • Pharmacology Research Institute

    Encino, California 91316
    United States

    Site Not Available

  • Collaborative Neuroscience Network, Inc.

    Garden Grove, California 92845
    United States

    Site Not Available

  • Behavioral Research Specialists, Llc

    Glendale, California 91206
    United States

    Site Not Available

  • Pharmacology Research Institute

    Los Alamitos, California 90720
    United States

    Site Not Available

  • Pharmacology Research Institute

    Newport Beach, California 92660
    United States

    Site Not Available

  • Neuropsychiatric Research Center Of Orange County

    Orange, California 92868
    United States

    Site Not Available

  • Pacific Clinical Research Medical Group

    Orange, California 92868
    United States

    Site Not Available

  • Anderson Clinical Research

    Redlands, California 92374
    United States

    Site Not Available

  • Affiliated Research Institute

    San Diego, California 92108
    United States

    Site Not Available

  • Artemis Institute For Clinical Research

    San Diego, California 92123
    United States

    Site Not Available

  • California Neuropsychopharmacology Clinical

    San Diego, California 92102
    United States

    Site Not Available

  • Pacific Research Network

    San Diego, California 92103
    United States

    Site Not Available

  • Sharp Mesa Vista Hospital

    San Diego, California 92123
    United States

    Site Not Available

  • Neuropsychiatric Research Center Of Orange County

    Santa Ana, California 92701
    United States

    Site Not Available

  • California Neuroscience Research Medical Group, Inc.

    Sherman Oaks, California 91403
    United States

    Site Not Available

  • Schuster Medical Research Institute

    Sherman Oaks, California 91403
    United States

    Site Not Available

  • Pacific Clinical Research Medical Group

    Upland, California 91786
    United States

    Site Not Available

  • Radiant Research, Inc.

    Denver, Colorado 80239
    United States

    Site Not Available

  • Western Affiliated Research Institute

    Denver, Colorado 80209
    United States

    Site Not Available

  • Connecticut Clinical Research

    Cromwell, Connecticut 06416
    United States

    Site Not Available

  • Comprehensive Psychiatric Care

    Norwich, Connecticut 06360
    United States

    Site Not Available

  • Meridien Research

    Brooksville, Florida 34601
    United States

    Site Not Available

  • Gulfcoast Clinical Research Center

    Fort Myers, Florida 33912
    United States

    Site Not Available

  • Amit Vijapura

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida 32806
    United States

    Site Not Available

  • Compass Research, Llc

    Orlando, Florida 32806
    United States

    Site Not Available

  • Comprehensive Clinical Development, Inc.

    Saint Petersburg, Florida 33716
    United States

    Site Not Available

  • Comprehensive Clinical Development, Inc.

    St Petersburg, Florida 33716
    United States

    Site Not Available

  • Comprehensive Neuroscience, Inc.

    St. Petersburg, Florida 33716
    United States

    Site Not Available

  • Stedman Clinical Trials

    Tampa, Florida 33613
    United States

    Site Not Available

  • Janus Center For Psychiatric Research

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Atlanta Institute Of Medicine & Research

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • Comprehensive Clinical Development, Inc

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30306
    United States

    Site Not Available

  • Carman Research

    Smyrna, Georgia 30080
    United States

    Site Not Available

  • Local Institution

    Chicago, Illinois 60640
    United States

    Site Not Available

  • Loyola University Medical Center

    Maywood, Illinois 60153
    United States

    Site Not Available

  • Alpine Clinic

    Lafayette, Indiana 47905
    United States

    Site Not Available

  • Clinco

    Terre Haute, Indiana 47802
    United States

    Site Not Available

  • Clinical Trials Technology, Inc

    Prairie Village, Kansas 66206
    United States

    Site Not Available

  • James G. Barbee, Md, Llc

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • J. Gary Booker, Md, Apmc

    Shreveport, Louisiana 71104
    United States

    Site Not Available

  • Mclean Hospital

    Belmont, Massachusetts 02478
    United States

    Site Not Available

  • Bio Behavioral Health

    Toms River, New Jersey 08755
    United States

    Site Not Available

  • Albuquerque Neuroscience, Inc.

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Spri Clinical Trials, Llc

    Brooklyn, New York 11235
    United States

    Site Not Available

  • Neurobehavioral Research, Inc.

    Cedarhurst, New York 11516
    United States

    Site Not Available

  • Comprehensive Clinical Development, Inc

    Fresh Meadows, New York 11366
    United States

    Site Not Available

  • Comprehensive Clinical Development, Inc

    Jamaica, New York 11432
    United States

    Site Not Available

  • Bioscience Research, Llc

    Mount Kisco, New York 10549
    United States

    Site Not Available

  • Village Clinical Research, Inc.

    New York, New York 10003
    United States

    Site Not Available

  • Finger Lakes Clinical Research

    Rochester, New York 14618
    United States

    Site Not Available

  • Local Institution

    Syracuse, New York 13210
    United States

    Site Not Available

  • Carolinas Healthcare System

    Charlotte, North Carolina 28203
    United States

    Site Not Available

  • Richard H. Weisler, Md, Pa & Assoc.

    Raleigh, North Carolina 27609
    United States

    Site Not Available

  • Northcoast Clinical Trials, Inc

    Beachwood, Ohio 44122
    United States

    Site Not Available

  • Patient Priority Clinical Sites, Llc

    Cincinnati, Ohio 45215
    United States

    Site Not Available

  • Midwest Clinical Research Center

    Dayton, Ohio 45417
    United States

    Site Not Available

  • Neurology & Neuroscience Center Of Ohio

    Toledo, Ohio 43623
    United States

    Site Not Available

  • Ips Research Company

    Oklahoma City, Oklahoma 73103
    United States

    Site Not Available

  • Tulsa Clinical Research, Llc

    Tulsa, Oklahoma 74104
    United States

    Site Not Available

  • Oregon Center For Clinical Investigations, Inc. (Occi, Inc)

    Portland, Oregon 97210
    United States

    Site Not Available

  • Summit Research Network (Oregon) Inc

    Portland, Oregon 97210
    United States

    Site Not Available

  • Oregon Center For Clinical Investigations, Inc (Occi, Inc)

    Salem, Oregon 97301
    United States

    Site Not Available

  • Lehigh Center For Clinical Research

    Allentown, Pennsylvania 18104
    United States

    Site Not Available

  • Suburban Research Associates

    Media, Pennsylvania 19063
    United States

    Site Not Available

  • Keystone Clinical Studies, Llc

    Norristown, Pennsylvania 19403
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Univ Of Penn

    Philadelphia, Pennsylvania 19104-3309
    United States

    Site Not Available

  • University Of Pennsylvania

    Philadelphia, Pennsylvania 19104-3309
    United States

    Site Not Available

  • Bioscience Research, Llc

    Pittsburgh, Pennsylvania 15219
    United States

    Site Not Available

  • Comprehensive Psychiatric Care

    Pittsburgh, Pennsylvania 06360
    United States

    Site Not Available

  • Insite Clinical Research

    Pittsburgh, Pennsylvania 15219
    United States

    Site Not Available

  • Lincoln Research

    Lincoln, Rhode Island 02865
    United States

    Site Not Available

  • Carolina Clinical Research Services

    Columbia, South Carolina 29201
    United States

    Site Not Available

  • Psychiatric Consultants, Pc

    Franklin, Tennessee 37067
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Community Clinical Research, Inc.

    Austin, Texas 78754
    United States

    Site Not Available

  • Futuresearch Trials

    Austin, Texas 78731
    United States

    Site Not Available

  • Futuresearch Trials Of Dallas

    Dallas, Texas 75231
    United States

    Site Not Available

  • Insite Clinical Research

    Desoto, Texas 75115
    United States

    Site Not Available

  • Baylor College Of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • Red Oak Psychiatry Associates, Pa

    Houston, Texas 77090
    United States

    Site Not Available

  • Ut Health-Houston

    Houston, Texas 77054
    United States

    Site Not Available

  • San Antonio Psychiatric Research Center

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Grayline Clinical Drug Trials

    Wichita Falls, Texas 76309
    United States

    Site Not Available

  • Ericksen Research And Development

    Clinton, Utah 84015
    United States

    Site Not Available

  • Radiant Research, Inc.

    Murray, Utah 84123
    United States

    Site Not Available

  • Lifetree Clinical Research

    Salt Lake City, Utah 84106
    United States

    Site Not Available

  • Psychiatric And Behavioral Solutions

    Salt Lake City, Utah 84105
    United States

    Site Not Available

  • Neuropsychiatric Associates

    Woodstock, Vermont 05091
    United States

    Site Not Available

  • Local Institution

    Herndon, Virginia 20170
    United States

    Site Not Available

  • Local Institution

    Richmond, Virginia 23219
    United States

    Site Not Available

  • Northwest Clinical Research Center

    Bellevue, Washington 98007
    United States

    Site Not Available

  • Summit Research Network (Seattle) Llc

    Seattle, Washington 98104
    United States

    Site Not Available

  • Northbrooke Research Center

    Brown Deer, Wisconsin 53223
    United States

    Site Not Available

  • Dean Foundation For Health Research & Education

    Middleton, Wisconsin 53562
    United States

    Site Not Available

  • Independent Psychiatric Consultants, Sc, Dba, Ipc Research

    Waukesha, Wisconsin 53188
    United States

    Site Not Available

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