Safety and Efficacy of Study Drug Versus Placebo for Negative Symptoms of Schizophrenia
1 other identifier
interventional
180
1 country
29
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 schizophrenia
Started May 2003
Shorter than P25 for phase_2 schizophrenia
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
June 25, 2003
CompletedFirst Posted
Study publicly available on registry
June 26, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2003
CompletedAugust 28, 2009
December 1, 2003
June 25, 2003
August 27, 2009
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Birmingham Psychiatry Pharmaceutical Studies, Inc.
Birmingham, Alabama, 35209, United States
IPR
Cerritos, California, 90703, United States
Synergy Clinical Research
Chula Vista, California, 91910, United States
Optimum Health Services
La Mesa, California, 91942, United States
Sierra Vista Hospital
Sacramento, California, 95823, United States
Clinical Innovations
Santa Ana, California, 92705, United States
Research Strategies
Torrance, California, 90503, United States
University of Colorado
Denver, Colorado, 80262, United States
Psychiatric Institute of Washington
Washington D.C., District of Columbia, 20016, United States
Berma Research Group
Hialeah, Florida, 33016, United States
Segal Institute for Clinical Research
North Miami, Florida, 33161, United States
Quantum Laboratories
Pompano Beach, Florida, 33064, United States
Med Psych Specialists, LLC
Atlanta, Georgia, 30340, United States
Alexian Brothers Behavioral Health Hospital
Hoffman Estates, Illinois, 60194, United States
Midwest Center for Neurobehavioral Medicine
Oakbrook Terrace, Illinois, 60181, United States
Unknown Facility
Shreveport, Louisiana, 71101, United States
University of Mississippi Medical Center-Dept. of Psychiatry
Jackson, Mississippi, 39216, United States
CNS Research Institute
Clementon, New Jersey, 14760, United States
Neurobehavioral Research
Lawrence, New York, 11559, United States
Global Research & Consulting
Olean, New York, 14760, United States
Bayley Seton Campus-Psychiatric Research Division
Staten Island, New York, 10304, United States
Behavioral Medical Research of Staten Island, P.C.
Staten Island, New York, 10305, United States
NorthCoast Clinical Trials
Beachwood, Ohio, 44122, United States
IPS Research
Oklahoma City, Oklahoma, 73103, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
Community Clinical Research
Austin, Texas, 78756, United States
MedLabs Research of Houston
Houston, Texas, 77057, United States
University Hills Clinical Research
Irving, Texas, 75062, United States
Milwaukee VA Medical Center
Milwaukee, Wisconsin, 53295, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 25, 2003
First Posted
June 26, 2003
Study Start
May 1, 2003
Study Completion
October 1, 2003
Last Updated
August 28, 2009
Record last verified: 2003-12