We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00330980
Recruitment Status : Completed
First Posted : May 29, 2006
Last Update Posted : March 20, 2014
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Dyslipidemias Drug: 40 mg Pravastatin (Pravachol) Drug: 20 mg Simvastatin Drug: Placebo Phase 4

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.

Study Design

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
Primary Completion Date : March 2004
Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Statins
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Information from the National Library of Medicine

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
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Beatrice A. Golomb, MD, PhD, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00330980     History of Changes
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

Keywords provided by University of California, San Diego:

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