Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00330980
Status:
COMPLETED
Last Update Posted:
2014-03-20
First Post:
2006-05-26
Brief Title:
Effects of Statin Medications on Mental Processes Behavior and Serotonin Levels
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Statins and Noncardiovascular Endpoints
Status:
COMPLETED
Status Verified Date:
2008-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL063055 | NIH | None | httpsreporternihgovquickSearchR01HL063055 |