Improving Symptoms of Schizophrenia and Schizoaffective Disorder by Supplementing Medications With Pravastatin

Phase 4

Completed

• Conditions: Schizophrenia; Schizoaffective Disorder

• Registration Number: NCT00177580
• Lead Sponsor: University of Pittsburgh

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 functioning.

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 15 total study visits over a 28-week period of time, one visit every 2 weeks.

Blood draws will be done once every 4 weeks throughout the study to monitor lipid levels, C-Reactive protein, AST, ALT, and CPK Total. Cognitive testing will be completed at the beginning of the study and at the end of the study. During the study visits, the staff will be monitoring vitals signs (weight, height, blood pressure, pulse, waist/hip ratio), possible side effects, positive and negative symptoms, mood symptoms, and overall functioning.

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Primary Completion: 2007-01
• Study Completion: 2007-07
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-08
• Last Update Posted: 2008-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
PANSS total score (clinical state)

Secondary Outcome Measures

Name	Time	Method
Safety
Positive Symptoms
Negative Symptoms
Depressive Symptoms
Cognitive Functions
Social Functioning
C-Reactive Protein changes
Lipid Enzyme changes

Trial Locations

Locations (1)

Western Psychiatric Institute & Clinic; 🇺🇸 Pittsburgh, Pennsylvania, United States