Safety and Efficacy of Study Drug Versus Placebo for Negative Symptoms of Schizophrenia - Full Text View

Sponsor:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00063297

Purpose

This study is to determine the efficacy (how well the drug works), safety, and side effects of the study medication compared to placebo in the treatment of the negative symptoms of schizophrenia in adults.

Condition	Intervention	Phase
Schizophrenia	Drug: R209130	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Estimated Enrollment:	180
Study Start Date:	May 2003
Estimated Study Completion Date:	October 2003

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion:

Adults aged 18-60
Current diagnosis of schizophrenia
Significant negative symptoms with few positive symptoms (e.g. hallucinations, delusions) and no evidence of major depression.
Female subjects of childbearing potential must test negative for pregnancy at the time of enrollment.
Subjects must be able to provide consent
Must be healthy based on medical exam, laboratory tests and electrocardiogram

Exclusion:

Female subjects who are either pregnant or nursing.
Acute or unstable medical conditions
Diseases of the central nervous system
Subjects who are judged clinically to be at serious risk for suicide or violence
Subjects with delusional disorder, psychotic disorder NOS, schizophreniform, schizoaffective disorder, bipolar disorder, attention deficit/hyperactivity disorder, major depressive disorder,alcohol or drug dependence

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00063297

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Locations

United States, Alabama
Birmingham Psychiatry Pharmaceutical Studies, Inc.
Birmingham, Alabama, United States, 35209
United States, California
Synergy Clinical Research
Chula Vista, California, United States, 91910
Clinical Innovations
Santa Ana, California, United States, 92705
IPR
Cerritos, California, United States, 90703
Optimum Health Services
La Mesa, California, United States, 91942
Sierra Vista Hospital
Sacramento, California, United States, 95823
Research Strategies
Torrance, California, United States, 90503
Research Strategies
Torrance, California, United States, 90503
United States, Colorado
University of Colorado
Denver, Colorado, United States, 80262
United States, District of Columbia
Psychiatric Institute of Washington
Washington, DC, District of Columbia, United States, 20016
United States, Florida
Quantum Laboratories
Pompano Beach, Florida, United States, 33064
Berma Research Group
Hialeah, Florida, United States, 33016
Segal Institute for Clinical Research
North Miami, Florida, United States, 33161
United States, Georgia
Med Psych Specialists, LLC
Atlanta, Georgia, United States, 30340
United States, Illinois
Midwest Center for Neurobehavioral Medicine
Oakbrook Terrace, Illinois, United States, 60181
Alexian Brothers Behavioral Health Hospital
Hoffman Estates, Illinois, United States, 60194
United States, Louisiana

Shreveport, Louisiana, United States, 71101
United States, Mississippi
University of Mississippi Medical Center-Dept. of Psychiatry
Jackson, Mississippi, United States, 39216
United States, New Jersey
CNS Research Institute
Clementon, New Jersey, United States, 14760
United States, New York
Bayley Seton Campus-Psychiatric Research Division
Staten Island, New York, United States, 10304
Global Research & Consulting
Olean, New York, United States, 14760
Behavioral Medical Research of Staten Island, P.C.
Staten Island, New York, United States, 10305
Neurobehavioral Research
Lawrence, New York, United States, 11559
United States, Ohio
NorthCoast Clinical Trials
Beachwood, Ohio, United States, 44122
United States, Oklahoma
IPS Research
Oklahoma City, Oklahoma, United States, 73103
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
United States, Texas
MedLabs Research of Houston
Houston, Texas, United States, 77057
Community Clinical Research
Austin, Texas, United States, 78756
University Hills Clinical Research
Irving, Texas, United States, 75062
United States, Wisconsin
Milwaukee VA Medical Center
Milwaukee, Wisconsin, United States, 53295

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More Information

No publications provided

Study ID Numbers:	CR004342
Study First Received:	June 25, 2003
Last Updated:	August 27, 2009
ClinicalTrials.gov Identifier:	NCT00063297 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

schizophrenia with negative symptoms

Additional relevant MeSH terms:

Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 30, 2009