Effects of Statin Medications on Mental Processes, Behavior, and Serotonin Levels

• Status: Completed
• Trial end date: 2004-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Statins are cholesterol-lowering medications that are often prescribed for individuals with high cholesterol and who are at risk for heart disease. Preliminary research has shown that statins may have other effects on the body that are unrelated to the heart. The purpose of this study is to evaluate the impact of statins on mood, mental processes, aggression, and serotonin levels.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Diego
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Pravastatin; Serotonin; Simvastatin

Criteria

Inclusion Criteria:

• LDL cholesterol level between 115-190 mg/dL

• Able to fast prior to blood draw

• Able to comfortably read and write in English

• Able and willing to refrain from donating whole blood during study participation

• Willing to abstain from consuming large amounts of grapefruit juice

Exclusion Criteria:

• Current use of lipid-lowering medications

• Symptomatic atherosclerotic disease, such as coronary artery disease, kidney failure or insufficiency, peripheral arterial disease, or cerebrovascular disease

• Cancer

• HIV infected

• Medical or psychiatric condition that prevents full study participation or follow-up (e.g., active psychosis)

• Active liver disease or unexplained persistent elevated transaminase levels

• Major surgery or hospitalization in the 3 months prior to study entry

• Current use of cyclosporin, erythromycin, clarithromycin, nefazodone, or any "azole" antifungals, including fluconazole, itraconazole, ketoconazole, mibefradil, or protease inhibitors

• Female of childbearing potential

• Current participation in another clinical trial