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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00330980
First received: May 26, 2006
Last updated: March 19, 2014
Last verified: July 2008

May 26, 2006
March 19, 2014
April 2000
March 2004   (final data collection date for primary outcome measure)
Effects of statins on cognition, serotonin biochemistry, and aggression [ Time Frame: Measured at Months 6 and 8 ] [ Designated as safety issue: No ]
Effects of statins on cognition, serotonin biochemistry, and aggression (measured at Months 6 and 8)
Complete list of historical versions of study NCT00330980 on ClinicalTrials.gov Archive Site
Effect of statins on mood, and other cognitive, behavioral, and biochemical measures [ Time Frame: Measured at Months 6 and 8 ] [ Designated as safety issue: No ]
Effect of statins on mood, and other cognitive, behavioral, and biochemical measures (measured at Months 6 and 8)
Not Provided
Not Provided
 
Effects of Statin Medications on Mental Processes, Behavior, and Serotonin Levels
Statins and Noncardiovascular Endpoints

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Dyslipidemias
  • Drug: 40 mg Pravastatin (Pravachol)
    Participants will receive 40 mg of pravastatin for 6 months.
  • Drug: 20 mg Simvastatin
    Participants will receive 20 mg of simvastatin for 6 months.
  • Drug: Placebo
    Participants will receive placebo for 6 months.
  • Experimental: 1
    Participants will receive 20 mg of simvastatin for 6 months.
    Intervention: Drug: 20 mg Simvastatin
  • Experimental: 2
    Participants will receive 40 mg of pravastatin for 6 months.
    Intervention: Drug: 40 mg Pravastatin (Pravachol)
  • Placebo Comparator: 3
    Participants will receive placebo for 6 months.
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
March 2004
March 2004   (final data collection date for primary outcome measure)

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
Both
20 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00330980
394, R01HL063055
Not Provided
Beatrice A. Golomb, MD, PhD, University of California, San Diego
University of California, San Diego
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Beatrice A. Golomb, MD, PhD University of California, San Diego
University of California, San Diego
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP