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
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 schizophrenia
Started Jul 2003
Typical duration for phase_4 schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedJanuary 15, 2008
January 1, 2008
3.5 years
September 13, 2005
January 8, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PANSS total score (clinical state)
Secondary Outcomes (8)
Safety
Positive Symptoms
Negative Symptoms
Depressive Symptoms
Cognitive Functions
- +3 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pittsburghlead
- Stanley Medical Research Institutecollaborator
Study Sites (1)
Western Psychiatric Institute & Clinic
Pittsburgh, Pennsylvania, 15213, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jaspreet S Brar, MD, MPH
University of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 15, 2005
Study Start
July 1, 2003
Primary Completion
January 1, 2007
Study Completion
July 1, 2007
Last Updated
January 15, 2008
Record last verified: 2008-01