Effects of Pravastatin on Cholesterol, Inflammation and Cognition in Schizophrenia

Completed · Phase 4 · Has a placebo group

Conditions studied: Schizophrenia, Schizoaffective Disorders, Schizophreniform Disorders

In brief

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

Key facts

Study ID

NCT01082588

Run by

Massachusetts General Hospital

People needed

60

Starts

2010-06-01

Expected to finish

2012-09-01

Last updated by the study team

2014-04-28

Who can join

Age: 18 and older, up to 68. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female
• Age 18-68 years
• Diagnosis of schizophrenia, any subtype, schizoaffective disorder, any subtype or schizophreniform disorder
• Well established compliance with outpatient medications including their antipsychotic medication

You may not qualify if…

• Inability to provide informed consent
• Current substance and alcohol abuse
• Significant medical illness, including congestive heart failure, severe cardiovascular disease, renal disease (serum creatinine > 1.5), severe hepatic impairment or active liver disease, anemia (hemoglobin <11.0 gm/dL), history of severe head injury, and not treated muscle disease.
• Psychiatrically unstable
• Women of child bearing potential who are pregnant, breastfeeding, or who are unwilling or unable to use an effective form of birth control during the entire study
• Subjects treated with anti-inflammatory drugs (including daily aspirin and ibuprofen), thiazide diuretics; agents that induce weight loss, and St. John's Wort will be excluded from the study
• Current history of untreated thyroid disease
• Current treatment with insulin
• Subjects being treated with drugs such as: colchicine, azole antifungals (fluconazole, ketoconazole, itraconazole); macrolide antibiotics (clarithromycin, erythromycin); HIV protease inhibitors (ritonavir, indinavir, saquinavir, nelfinavir) that inhibit the CYP 450 3A liver enzyme
• Known hypersensitivity to pravastatin or any of its components

Where it is running

• Freedom Trail Clinic — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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