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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
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
University of California, San Diego

Tracking Information
First Submitted Date  ICMJE May 26, 2006
First Posted Date  ICMJE May 29, 2006
Last Update Posted Date March 20, 2014
Study Start Date  ICMJE April 2000
Actual Primary Completion Date March 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2008)
Effects of statins on cognition, serotonin biochemistry, and aggression [ Time Frame: Measured at Months 6 and 8 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 26, 2006)
Effects of statins on cognition, serotonin biochemistry, and aggression (measured at Months 6 and 8)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2008)
Effect of statins on mood, and other cognitive, behavioral, and biochemical measures [ Time Frame: Measured at Months 6 and 8 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2006)
Effect of statins on mood, and other cognitive, behavioral, and biochemical measures (measured at Months 6 and 8)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Statin Medications on Mental Processes, Behavior, and Serotonin Levels
Official Title  ICMJE Statins and Noncardiovascular Endpoints
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dyslipidemias
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: May 26, 2006)
1000
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2004
Actual Primary Completion Date March 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00330980
Other Study ID Numbers  ICMJE 394
R01HL063055 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Beatrice A. Golomb, MD, PhD, University of California, San Diego
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Beatrice A. Golomb, MD, PhD University of California, San Diego
PRS Account University of California, San Diego
Verification Date July 2008

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