Clinical trial NCT00177580: Improving Symptoms of Schizophrenia and Schizoaffective Disorder by Supplementing Medications With Pravastatin
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: schizophrenia
schizoaffective disorder
positive symptoms
negative symptoms
cognitive functioning
pravastatin
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Stanley Medical Research Institute
First posted: 2005-09-15
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: PANSS total score (clinical state)
Secondary outcomes:
measure: Safety
measure: Positive Symptoms
measure: Negative Symptoms
measure: Depressive Symptoms
measure: Cognitive Functions
measure: Social Functioning
measure: C-Reactive Protein changes
measure: Lipid Enzyme changes
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Western Psychiatric Institute & Clinic
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Jaspreet S Brar, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: