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

University of Pittsburgh

Status and phase

Completed

Phase 4

Conditions

Schizophrenia

Schizoaffective Disorder

Treatments

Drug: Pravastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00177580

0308022

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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