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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00177580

Enrollment

Registered

2005-09-15

Start date

2003-07-31

Completion date

2007-07-31

Last updated

2008-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizoaffective Disorder, Schizophrenia

Keywords

schizophrenia, schizoaffective disorder, positive symptoms, negative symptoms, cognitive functioning, pravastatin

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.

Interventions

DRUGPravastatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
PANSS total score (clinical state)	—

Secondary

Measure	Time frame
Positive Symptoms	—
Negative Symptoms	—
Depressive Symptoms	—
Safety	—
Social Functioning	—
C-Reactive Protein changes	—
Lipid Enzyme changes	—
Cognitive Functions	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026