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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00177580
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : January 15, 2008
Stanley Medical Research Institute
Information provided by:
University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: Pravastatin Phase 4

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : July 2003
Actual Primary Completion Date : January 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Primary Outcome Measures :
  1. PANSS total score (clinical state)

Secondary Outcome Measures :
  1. Safety
  2. Positive Symptoms
  3. Negative Symptoms
  4. Depressive Symptoms
  5. Cognitive Functions
  6. Social Functioning
  7. C-Reactive Protein changes
  8. Lipid Enzyme changes

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00177580

United States, Pennsylvania
Western Psychiatric Institute & Clinic
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Stanley Medical Research Institute
Principal Investigator: Jaspreet S Brar, MD, MPH University of Pittsburgh Identifier: NCT00177580     History of Changes
Other Study ID Numbers: 0308022
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: January 15, 2008
Last Verified: January 2008

Keywords provided by University of Pittsburgh:
schizoaffective disorder
positive symptoms
negative symptoms
cognitive functioning

Additional relevant MeSH terms:
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors