Official Title: “A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial of Adjunctive Treatment With Pravastatin in Partially Remitted Patients With Schizophrenia or Schizoaffective Disorder”

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.

Study Type: Interventional

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

Study Primary Completion Date: January 2007

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.

Intervention(s) in this Clinical Trial

• Drug: Pravastatin

Primary Measures

• PANSS total score (clinical state)

Secondary Measures

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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Pittsburgh

Overall Clinical Trial Officials and Contacts

Jaspreet S Brar, MD, MPH Principal Investigator University of Pittsburgh  

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00177580

Study ID Number: 0308022

ClinicalTrials.gov Identifier: NCT00177580

Health Authority: United States: Food and Drug Administration

This website describes the pravastatin research study, and describes the purpose of our research program.