Effects of Statin Medications on Mental Processes, Behavior, and Serotonin Levels
Statins and Noncardiovascular Endpoints
2 other identifiers
interventional
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2000
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 26, 2006
CompletedFirst Posted
Study publicly available on registry
May 29, 2006
CompletedMarch 20, 2014
July 1, 2008
3.9 years
May 26, 2006
March 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effects of statins on cognition, serotonin biochemistry, and aggression
Measured at Months 6 and 8
Secondary Outcomes (1)
Effect of statins on mood, and other cognitive, behavioral, and biochemical measures
Measured at Months 6 and 8
Study Arms (3)
1
EXPERIMENTALParticipants will receive 20 mg of simvastatin for 6 months.
2
EXPERIMENTALParticipants will receive 40 mg of pravastatin for 6 months.
3
PLACEBO COMPARATORParticipants will receive placebo for 6 months.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Diego
La Jolla, California, 92093-0995, United States
Related Publications (7)
Golomb BA, Criqui MH, White HL, Dimsdale JE. The UCSD Statin Study: a randomized controlled trial assessing the impact of statins on selected noncardiac outcomes. Control Clin Trials. 2004 Apr;25(2):178-202. doi: 10.1016/j.cct.2003.08.014.
PMID: 15020036BACKGROUNDGolomb BA, Criqui MH, White H, Dimsdale JE. Conceptual foundations of the UCSD Statin Study: a randomized controlled trial assessing the impact of statins on cognition, behavior, and biochemistry. Arch Intern Med. 2004 Jan 26;164(2):153-62. doi: 10.1001/archinte.164.2.153.
PMID: 14744838BACKGROUNDGolomb BA, Dimsdale JE, Koslik HJ, Evans MA, Lu X, Rossi S, Mills PJ, White HL, Criqui MH. Statin Effects on Aggression: Results from the UCSD Statin Study, a Randomized Control Trial. PLoS One. 2015 Jul 1;10(7):e0124451. doi: 10.1371/journal.pone.0124451. eCollection 2015.
PMID: 26132393DERIVEDGolomb BA, Chan VT, Evans MA, Koperski S, White HL, Criqui MH. The older the better: are elderly study participants more non-representative? A cross-sectional analysis of clinical trial and observational study samples. BMJ Open. 2012 Dec 14;2(6):e000833. doi: 10.1136/bmjopen-2012-000833. Print 2012.
PMID: 23242479DERIVEDGolomb BA, Koperski S, White HL. Association between more frequent chocolate consumption and lower body mass index. Arch Intern Med. 2012 Mar 26;172(6):519-21. doi: 10.1001/archinternmed.2011.2100. No abstract available.
PMID: 22450943DERIVEDGolomb BA, Evans MA, White HL, Dimsdale JE. Trans fat consumption and aggression. PLoS One. 2012;7(3):e32175. doi: 10.1371/journal.pone.0032175. Epub 2012 Mar 5.
PMID: 22403632DERIVEDGolomb BA, Dimsdale JE, White HL, Ritchie JB, Criqui MH. Reduction in blood pressure with statins: results from the UCSD Statin Study, a randomized trial. Arch Intern Med. 2008 Apr 14;168(7):721-7. doi: 10.1001/archinte.168.7.721.
PMID: 18413554DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Beatrice A. Golomb, MD, PhD
University of California, San Diego
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 26, 2006
First Posted
May 29, 2006
Study Start
April 1, 2000
Primary Completion
March 1, 2004
Study Completion
March 1, 2004
Last Updated
March 20, 2014
Record last verified: 2008-07