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
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

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

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Pravastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 23, 2014