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

September 13, 2005
January 8, 2008
July 2003
January 2007   (final data collection date for primary outcome measure)
PANSS total score (clinical state)
Same as current
Complete list of historical versions of study NCT00177580 on ClinicalTrials.gov Archive Site
  • Safety
  • Positive Symptoms
  • Negative Symptoms
  • Depressive Symptoms
  • Cognitive Functions
  • Social Functioning
  • C-Reactive Protein changes
  • Lipid Enzyme changes
Same as current
Not Provided
Not Provided
 
Improving Symptoms of Schizophrenia and Schizoaffective Disorder by Supplementing Medications With Pravastatin
A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial of Adjunctive Treatment With Pravastatin in Partially Remitted Patients With Schizophrenia or Schizoaffective Disorder

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Schizophrenia
  • Schizoaffective Disorder
Drug: Pravastatin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
July 2007
January 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00177580
0308022
Not Provided
Not Provided
University of Pittsburgh
Stanley Medical Research Institute
Principal Investigator: Jaspreet S Brar, MD, MPH University of Pittsburgh
University of Pittsburgh
January 2008

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