Status:
COMPLETED
Improving Symptoms of Schizophrenia and Schizoaffective Disorder by Supplementing Medications With Pravastatin
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Stanley Medical Research Institute
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This study supplements patients' current medications with Pravastatin, a cholesterol-lowering medication, to try to improve residual symptoms of schizophrenia, and also to improve cognitive functionin...
Detailed Description
This study supplements patients' current medications with Pravastatin, a cholesterol-lowering medication, to try to improve residual symptoms and also to improve cognitive functioning. It consists of ...
Eligibility Criteria
Inclusion
- Diagnosis of schizophrenia or schizoaffective disorder
- Male and female subjects; age 18-65 years inclusive
- Ability to provide informed consent
- No psychiatric hospitalization in the last 30 days prior to randomization
- PANSS score at study entry between 80 and 120 inclusive, OR those who continue to experience some residual positive and/or negative symptoms and are not at their baseline level of functioning.
- Current psychiatric medications stable for at least 30 days
- Currently receiving only one antipsychotic medication
- Female subjects of child-bearing age must use an acceptable method of birth control
Exclusion
- Active, uncontrolled, or chronic liver disease
- Heart failure
- Current alcohol abuse or dependence
- Female subjects who are pregnant, lactating or plan to become pregnant during the study period
- History of allergic reaction with any statin in the past
- Kidney disorder or other evidence of renal dysfunction
- Uncontrolled diabetes
- Untreated hyperlipidemia
- Concurrently receiving treatment with cyclosporine, gemfibrozil, clofibrate, fenofibrate, niacin, macrolide antibiotics, erythromycin, HIV protease inhibitors, nefazodone, or verapamil
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2007
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00177580
Start Date
July 1 2003
End Date
July 1 2007
Last Update
January 15 2008
Active Locations (1)
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1
Western Psychiatric Institute & Clinic
Pittsburgh, Pennsylvania, United States, 15213