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

This study has been completed.

Sponsor:

Collaborator:

Stanley Medical Research Institute

Information provided by:

University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT00177580

First received: September 13, 2005

Last updated: January 8, 2008

Last verified: January 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

January 8, 2008

Start Date ^ICMJE

July 2003

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

PANSS total score (clinical state)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00177580 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Schizophrenia
Schizoaffective Disorder

Intervention ^ICMJE

Drug: Pravastatin

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

July 2007

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00177580

Other Study ID Numbers ^ICMJE

0308022

Has Data Monitoring Committee

Responsible Party

Study Sponsor ^ICMJE

University of Pittsburgh

Collaborators ^ICMJE

Stanley Medical Research Institute

Investigators ^ICMJE

Principal Investigator:

Jaspreet S Brar, MD, MPH

University of Pittsburgh

Information Provided By

University of Pittsburgh

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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