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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00177580
• Other study ID #: 0308022
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: January 8, 2008
• Start date: July 2003
• Est. completion date: July 2007

Study information

• Verified date: January 2008
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• Pravastatin

Locations

Country	Name	City	State
United States	Western Psychiatric Institute & Clinic	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Stanley Medical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PANSS total score (clinical state)
Secondary	Safety
Secondary	Positive Symptoms
Secondary	Negative Symptoms
Secondary	Depressive Symptoms
Secondary	Cognitive Functions
Secondary	Social Functioning
Secondary	C-Reactive Protein changes
Secondary	Lipid Enzyme changes