Overview

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

Status:
Completed
Trial end date:
2007-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Pittsburgh
Collaborator:
Stanley Medical Research Institute
Treatments:
Pravastatin
Criteria
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