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

This study has been completed.
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
University of California, San Diego Identifier:
First received: May 26, 2006
Last updated: March 19, 2014
Last verified: July 2008
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
Drug: 40 mg Pravastatin (Pravachol)
Drug: 20 mg Simvastatin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Statins and Noncardiovascular Endpoints

Resource links provided by NLM:

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Effects of statins on cognition, serotonin biochemistry, and aggression [ Time Frame: Measured at Months 6 and 8 ]

Secondary Outcome Measures:
  • Effect of statins on mood, and other cognitive, behavioral, and biochemical measures [ Time Frame: Measured at Months 6 and 8 ]

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
Experimental: 1
Participants will receive 20 mg of simvastatin for 6 months.
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.
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.
Drug: Placebo
Participants will receive placebo for 6 months.

Detailed Description:

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   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00330980

United States, California
University of California, San Diego
La Jolla, California, United States, 92093-0995
Sponsors and Collaborators
University of California, San Diego
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Beatrice A. Golomb, MD, PhD University of California, San Diego
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Beatrice A. Golomb, MD, PhD, University of California, San Diego Identifier: NCT00330980     History of Changes
Other Study ID Numbers: 394
R01HL063055 ( US NIH Grant/Contract Award Number )
Study First Received: May 26, 2006
Last Updated: March 19, 2014

Keywords provided by University of California, San Diego:

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Physiological Effects of Drugs processed this record on May 25, 2017