DyslipidemiasPhase 4NCT00330980
Effects of Statin Medications on Mental Processes, Behavior, and Serotonin Levels
A Phase 4 study testing 40 mg Pravastatin (Pravachol) and 20 mg Simvastatin in people with Dyslipidemias, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- 40 mg Pravastatin (Pravachol) and 20 mg Simvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2000to Mar 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
La Jolla, California, 92093-0995
About this study
Official title: 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.
Read the 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.
- Conditions
- Dyslipidemias
- Being tested
- 40 mg Pravastatin (Pravachol), 20 mg Simvastatin, Placebo
- Keywords
- Cognition, Statins, Serotonin, Cholesterol
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40 mg Pravastatin (Pravachol)Drug
Participants will receive 40 mg of pravastatin for 6 months.
20 mg SimvastatinDrug
Participants will receive 20 mg of simvastatin for 6 months.
PlaceboDrug
Participants will receive placebo for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive 20 mg of simvastatin for 6 months. Receives: Drug: 20 mg Simvastatin |
| 2 | Experimental | Participants will receive 40 mg of pravastatin for 6 months. Receives: Drug: 40 mg Pravastatin (Pravachol) |
| 3 | Placebo comparator | Participants will receive placebo for 6 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of statins on cognition, serotonin biochemistry, and aggression
Measured: Measured at Months 6 and 8
Secondary outcomes (1)
Effect of statins on mood, and other cognitive, behavioral, and biochemical measures
Measured: Measured at Months 6 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2006 (estimated)
- Study startApr 2000
- Primary completionMar 2004
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Beatrice A. Golomb, MD, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00330980
- Sponsor's protocol ID
- 394
- Other IDs
- R01HL063055
- Status last verified
- Jul 2008
- First submitted
- 26 May 2006
- Last updated
- 20 Mar 2014
- Results posted
- No
Publications
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.
PubMed 15020036Golomb 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.
PubMed 14744838Golomb 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.
PubMed 26132393Golomb 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.
PubMed 23242479Golomb 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.
PubMed 22450943Golomb 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.
PubMed 22403632Golomb 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.
PubMed 18413554
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statins and Noncardiovascular Endpoints
- ClinicalTrials.gov ID
- NCT00330980
- Acronym / sponsor ID
- 394
- Conditions
- Dyslipidemias
- Keywords
- Cognition, Statins, Serotonin, Cholesterol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 2000
- Primary completion
- Mar 2004 (actual)
- Study completion
- Mar 2004 (actual)
- First posted
- 29 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 20 mg SimvastatinParticipants will receive 20 mg of simvastatin for 6 months. |
| 2 | Experimental | Drug: 40 mg Pravastatin (Pravachol)Participants will receive 40 mg of pravastatin for 6 months. |
| 3 | Placebo comparator | Drug: PlaceboParticipants will receive placebo for 6 months. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 40 mg Pravastatin (Pravachol)Participants will receive 40 mg of pravastatin for 6 months. | Drug | 2 |
| 20 mg SimvastatinParticipants will receive 20 mg of simvastatin for 6 months. | Drug | 1 |
| PlaceboParticipants will receive placebo for 6 months. | Drug | 3 |
Primary outcome
Effects of statins on cognition, serotonin biochemistry, and aggression
Time frame: Measured at Months 6 and 8
1 secondary outcome
Effect of statins on mood, and other cognitive, behavioral, and biochemical measures
Time frame: Measured at Months 6 and 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2014.
- Background: PubMed 15020036Golomb 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.
- Background: PubMed 14744838Golomb 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.
- Derived from this study: PubMed 26132393Golomb 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.
- Derived from this study: PubMed 23242479Golomb 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.
- Derived from this study: PubMed 22450943Golomb 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.
- Derived from this study: PubMed 22403632Golomb 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.
- Derived from this study: PubMed 18413554Golomb 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beatrice A. Golomb, MD, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 40 mg Pravastatin (Pravachol) and 20 mg Simvastatin in people with Dyslipidemias, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of statins on cognition, serotonin biochemistry, and aggression (time frame: Measured at Months 6 and 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00330980, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2014.