Safety and Efficacy of Study Drug Versus Placebo for Negative Symptoms of Schizophrenia
NCT ID: NCT00063297
Last Updated: 2009-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
180 participants
INTERVENTIONAL
2003-05-31
2003-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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R209130
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
60 Years
ALL
No
Sponsors
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
INDUSTRY
Locations
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Birmingham Psychiatry Pharmaceutical Studies, Inc.
Birmingham, Alabama, United States
IPR
Cerritos, California, United States
Synergy Clinical Research
Chula Vista, California, United States
Optimum Health Services
La Mesa, California, United States
Sierra Vista Hospital
Sacramento, California, United States
Clinical Innovations
Santa Ana, California, United States
Research Strategies
Torrance, California, United States
University of Colorado
Denver, Colorado, United States
Psychiatric Institute of Washington
Washington D.C., District of Columbia, United States
Berma Research Group
Hialeah, Florida, United States
Segal Institute for Clinical Research
North Miami, Florida, United States
Quantum Laboratories
Pompano Beach, Florida, United States
Med Psych Specialists, LLC
Atlanta, Georgia, United States
Alexian Brothers Behavioral Health Hospital
Hoffman Estates, Illinois, United States
Midwest Center for Neurobehavioral Medicine
Oakbrook Terrace, Illinois, United States
Shreveport, Louisiana, United States
University of Mississippi Medical Center-Dept. of Psychiatry
Jackson, Mississippi, United States
CNS Research Institute
Clementon, New Jersey, United States
Neurobehavioral Research
Lawrence, New York, United States
Global Research & Consulting
Olean, New York, United States
Bayley Seton Campus-Psychiatric Research Division
Staten Island, New York, United States
Behavioral Medical Research of Staten Island, P.C.
Staten Island, New York, United States
NorthCoast Clinical Trials
Beachwood, Ohio, United States
IPS Research
Oklahoma City, Oklahoma, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Community Clinical Research
Austin, Texas, United States
MedLabs Research of Houston
Houston, Texas, United States
University Hills Clinical Research
Irving, Texas, United States
Milwaukee VA Medical Center
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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CR004342
Identifier Type: -
Identifier Source: org_study_id