Improving Symptoms of Schizophrenia and Schizoaffective Disorder by Supplementing Medications With Pravastatin
This study has been completed.
Sponsor:
University of Pittsburgh
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
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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) |
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
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 May 23, 2013