Effects of Statin Medications on Mental Processes, Behavior, and Serotonin Levels
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ClinicalTrials.gov Identifier: NCT00330980 |
Recruitment Status :
Completed
First Posted : May 29, 2006
Last Update Posted : March 20, 2014
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Condition or disease | Intervention/treatment | Phase |
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Dyslipidemias | Drug: 40 mg Pravastatin (Pravachol) Drug: 20 mg Simvastatin Drug: Placebo | Phase 4 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1000 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Statins and Noncardiovascular Endpoints |
Study Start Date : | April 2000 |
Actual Primary Completion Date : | March 2004 |
Actual Study Completion Date : | March 2004 |

Arm | Intervention/treatment |
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Experimental: 1
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. |
Experimental: 2
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. |
Placebo Comparator: 3
Participants will receive placebo for 6 months.
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Drug: Placebo
Participants will receive placebo for 6 months. |
- Effects of statins on cognition, serotonin biochemistry, and aggression [ Time Frame: Measured at Months 6 and 8 ]
- Effect of statins on mood, and other cognitive, behavioral, and biochemical measures [ Time Frame: Measured at Months 6 and 8 ]

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330980
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Beatrice A. Golomb, MD, PhD, University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT00330980 |
Other Study ID Numbers: |
394 R01HL063055 ( U.S. NIH Grant/Contract ) |
First Posted: | May 29, 2006 Key Record Dates |
Last Update Posted: | March 20, 2014 |
Last Verified: | July 2008 |
Cognition Statins Serotonin Cholesterol |
Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Simvastatin Pravastatin Anticholesteremic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |