Schizophrenia Clinical Trial
Official title:
Phase 4 Study of the Effects of Pravastatin on Cholesterol Levels, Inflammation and Cognition in Schizophrenia
This study involves people with schizophrenia or schizoaffective disorder, who are currently
taking antipsychotic medications. Some antipsychotic medications may cause an increase in
cholesterol levels, which may lead to inflammation in the body. Inflammation poses a risk in
developing heart disease, diabetes and problems with brain function. The purpose of this
study is to see if pravastatin can:
- Lower cholesterol
- Decrease inflammation
- Improve cognition in patients with schizophrenia
This study is a 12-week randomized, double-blind, placebo-controlled pilot study of pravastatin 40mg a day, administered for 12 consecutive weeks to subjects with schizophrenia to examine pravastatin's effects on lowering cholesterol levels and inflammatory markers, and improving cognition. The study will be conducted at the Freedom Trail Clinic and will use the Massachusetts General Hospital Clinical Research Center. The innovative approach of using pravastatin to not only decrease cholesterol levels, but to decrease inflammation and improve cognition in patients with schizophrenia is promising and may lead to a different approach to treatment in this population. ;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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