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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00330980 |
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.
Condition | Intervention | Phase |
Dyslipidemias |
Drug: 40 mg Pravastatin (Pravachol) Drug: 20 mg Simvastatin Drug: Placebo |
Phase IV |
MedlinePlus related topics: | Cholesterol |
ChemIDplus related topics: | Pravastatin Pravastatin sodium Simvastatin Serotonin Cholest-5-en-3-ol (3beta)- |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Pharmacodynamics Study |
Official Title: | Statins and Noncardiovascular Endpoints |
Estimated Enrollment: | 1000 |
Study Start Date: | April 2000 |
Study Completion Date: | March 2004 |
Primary Completion Date: | March 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Participants will receive 20 mg of simvastatin for 6 months.
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Drug: 20 mg Simvastatin
Participants will receive 20 mg of simvastatin for 6 months.
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2: Experimental
Participants will receive 40 mg of pravastatin for 6 months.
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Drug: 40 mg Pravastatin (Pravachol)
Participants will receive 40 mg of pravastatin for 6 months.
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3: Placebo Comparator
Participants will receive placebo for 6 months.
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Drug: Placebo
Participants will receive placebo for 6 months.
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Individuals at risk for coronary artery disease are often prescribed statins, which are medications that reduce the amount of cholesterol in the blood. By lowering cholesterol levels, these individuals have a lower incidence of heart disease, heart attacks, and stroke. Simvastatin and pravastatin are two common statins that are often prescribed for individuals with high cholesterol. While statins are effective at lowering cholesterol levels, their effect on mood, behavior, and aggression has not been widely studied. Preliminary research has shown that lowering cholesterol levels may lead to an increase in aggressive behaviors and a change in cognitive function. Serotonin, a type of neurotransmitter, is believed to play an important role in the regulation of mood, as well as behavior and cognition. The direct effect of statins on serotonin levels remains unknown. The purpose of this study is to evaluate the effect of simvastatin and pravastatin on mood, cognition, aggression, and serotonin levels.
This study will enroll individuals who do not currently take cholesterol-lowering medications. Participants will be randomly assigned to receive 20 mg of simvastatin, 40 mg of pravastatin, or placebo for 6 months. Study visits will occur at baseline and Months 1, 3, 6, and 8. Height, weight, and waist circumference will be measured at all study visits. Blood and urine will be collected for laboratory testing, and standardized psychological questionnaires will assess cognition, aggression, mental flexibility, memory, depression, sleep quality, and quality of life at Months 1, 6, and 8. At Month 3, medication side effects will be monitored and a liver function test will be performed. Participants' partners will take part in a telephone interview at this time. At baseline and Month 6, some participants will undergo cardiac reactivity testing. During this procedure, participants will be videotaped and monitored for vital sign changes (blood pressure and heart rate) while they talk about potentially stressful situations.
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |||||
University of California, San Diego | |||||
La Jolla, California, United States, 92093-0995 |
Principal Investigator: | Beatrice A. Golomb, MD, PhD | University of California, San Diego |
Responsible Party: | University of California, San Diego ( Beatrice A. Golomb, MD, PhD ) |
Study ID Numbers: | 394, R01 HL063055 |
First Received: | May 26, 2006 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00330980 |
Health Authority: | United States: Federal Government |
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