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

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pravastatin
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, schizoaffective disorder, positive symptoms, negative symptoms, cognitive functioning, pravastatin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Western Psychiatric Institute & Clinic

Outcomes

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

Full Information

First Posted
September 13, 2005
Last Updated
January 8, 2008
Sponsor
University of Pittsburgh
Collaborators
Stanley Medical Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00177580
Brief Title
Improving Symptoms of Schizophrenia and Schizoaffective Disorder by Supplementing Medications With Pravastatin
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial of Adjunctive Treatment With Pravastatin in Partially Remitted Patients With Schizophrenia or Schizoaffective Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pittsburgh
Collaborators
Stanley Medical Research Institute

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
schizophrenia, schizoaffective disorder, positive symptoms, negative symptoms, cognitive functioning, pravastatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pravastatin
Primary Outcome Measure Information:
Title
PANSS total score (clinical state)
Secondary Outcome Measure Information:
Title
Safety
Title
Positive Symptoms
Title
Negative Symptoms
Title
Depressive Symptoms
Title
Cognitive Functions
Title
Social Functioning
Title
C-Reactive Protein changes
Title
Lipid Enzyme changes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaspreet S Brar, MD, MPH
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Psychiatric Institute & Clinic
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.wpic.pitt.edu/research/SWRP/
Description
This website describes the pravastatin research study, and describes the purpose of our research program.

Learn more about this trial

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

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