NCT01082588

Effects of Pravastatin on Cholesterol, Inflammation and Cognition in Schizophrenia

Phase 4 Study of the Effects of Pravastatin on Cholesterol Levels, Inflammation and Cognition in Schizophrenia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 68 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Schizophrenia
• Schizoaffective Disorders
• Schizophreniform Disorders

Interventions

Type	Name	Description
DRUG	Pravastatin	pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
DRUG	Placebo	pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2010-03-08
• Last updated: 2014-04-28
• Results posted: 2014-04-28

Locations

1 site across 1 country: United States