Effects of Pravastatin on Cholesterol, Inflammation and Cognition in Schizophrenia

Mass General Brigham

Status and phase

Completed

Phase 4

Conditions

Schizoaffective Disorders

Schizophreniform Disorders

Schizophrenia

Treatments

Drug: Pravastatin

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01082588

2009-P-002524

09T-1296 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 68 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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