Improving Symptoms of Schizophrenia and Schizoaffective Disorder by Supplementing Medications With Pravastatin - Full Text View

Sponsors and Collaborators:	University of Pittsburgh Stanley Medical Research Institute
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00177580

Purpose

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.

Condition	Intervention	Phase
Schizophrenia Schizoaffective Disorder	Drug: Pravastatin	Phase IV

MedlinePlus related topics: Schizophrenia

Drug Information available for: Pravastatin Pravastatin sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial of Adjunctive Treatment With Pravastatin in Partially Remitted Patients With Schizophrenia or Schizoaffective Disorder

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

PANSS total score (clinical state)

Secondary Outcome Measures:

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

Estimated Enrollment:	72
Study Start Date:	July 2003
Study Completion Date:	July 2007
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00177580

Locations

United States, Pennsylvania
Western Psychiatric Institute & Clinic
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

Stanley Medical Research Institute

Investigators

Principal Investigator:

Jaspreet S Brar, MD, MPH

University of Pittsburgh

More Information

This website describes the pravastatin research study, and describes the purpose of our research program. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Study ID Numbers:	0308022
Study First Received:	September 13, 2005
Last Updated:	January 8, 2008
ClinicalTrials.gov Identifier:	NCT00177580
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:

schizophrenia
schizoaffective disorder
positive symptoms

negative symptoms
cognitive functioning
pravastatin

Study placed in the following topic categories:

Schizophrenia
Pravastatin
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Antimetabolites
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009