Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217828
Status:
COMPLETED
Last Update Posted:
2014-06-11
First Post:
2005-09-19
Brief Title:
Effects of Citalopram on Hostility and CHD Risk
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2014-06
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:
To evaluate the therapeutic effects of the serotonergic agent citalopram on hostility and other behavioral risk factors and biological markers of disease risk serum lipids insulin and glucose autonomic balance and stress-related cardiovascular reactivity platelet activation
Detailed Description:
BACKGROUND
Hostility a broad personality dimension comprised of behavioral tendencies cognitive biases and emotional or motivational characteristics appears to play an important role in the development of coronary heart disease CHD Furthermore hostility apparently is important not only as a function of its direct relationship to disease development by virtue of its well documented link to a wide range of other risk factors including life style factors eg tobacco and alcohol use imprudent diet cardiovascular reactivity to stressful circumstances and physiological indices eg reactivity to acute stress lipid levels platelet activity glucose regulation It has been hypothesized that a common pathway underlying each of these factors is described by the serotonin system and by dys regulation of central serotonin pathways Indeed studies 1 and 2 of this program project application are devoted to an elaboration of this pathway as underlying behavioral psychological physiological and metabolic contributors to the development of CHD The focus of this project is on the impact of short treatment with a selective serotonin reuptake inhibitor SSRI on hostility and the wide range of associated risk factors for CHD Should this study prove successful it will have the potential of significantly impacting treatment approaches that are aimed at reducing risk for the development and progression of CHD
The study is one of four subprojects within a Program Project Grant entitled Biobehavioral Studies of Cardiovascular Disease
DESIGN NARRATIVE
This is randomized placebo-controlled clinical trial of a select population with the core questions revolving around the impact of brief 11 week treatment with citalopram a selective serotonin reuptake inhibitor SSRI on hostility as measured a number of ways Healthy individuals who score above the median on standard measures of hostility will be identified While questionnaire measures will be used to screen and select individuals a host of measures of hostility will be employed to more fully capture the wide ranging aspects of this personality dimension and thereby better ascertain the impact of the active agent In addition to the measurement of the central personality dimension of interest a wide range of other factors are to be measured Life style risk factors measured include eg the use of salivary cotinine to assess the validity of participants self-report regarding tobacco use the use of unannounced 24 hour dietary recalls the use of pedometer to assess physical activity autonomic activity eg the wide range of indices available through the use of impedance cardiography the use of heart rate variability baroreceptor sensitivity and platelet activity
Hostility a broad personality dimension comprised of behavioral tendencies cognitive biases and emotional or motivational characteristics appears to play an important role in the development of coronary heart disease CHD Furthermore hostility apparently is important not only as a function of its direct relationship to disease development by virtue of its well documented link to a wide range of other risk factors including life style factors eg tobacco and alcohol use imprudent diet cardiovascular reactivity to stressful circumstances and physiological indices eg reactivity to acute stress lipid levels platelet activity glucose regulation It has been hypothesized that a common pathway underlying each of these factors is described by the serotonin system and by dys regulation of central serotonin pathways Indeed studies 1 and 2 of this program project application are devoted to an elaboration of this pathway as underlying behavioral psychological physiological and metabolic contributors to the development of CHD The focus of this project is on the impact of short treatment with a selective serotonin reuptake inhibitor SSRI on hostility and the wide range of associated risk factors for CHD Should this study prove successful it will have the potential of significantly impacting treatment approaches that are aimed at reducing risk for the development and progression of CHD
The study is one of four subprojects within a Program Project Grant entitled Biobehavioral Studies of Cardiovascular Disease
DESIGN NARRATIVE
This is randomized placebo-controlled clinical trial of a select population with the core questions revolving around the impact of brief 11 week treatment with citalopram a selective serotonin reuptake inhibitor SSRI on hostility as measured a number of ways Healthy individuals who score above the median on standard measures of hostility will be identified While questionnaire measures will be used to screen and select individuals a host of measures of hostility will be employed to more fully capture the wide ranging aspects of this personality dimension and thereby better ascertain the impact of the active agent In addition to the measurement of the central personality dimension of interest a wide range of other factors are to be measured Life style risk factors measured include eg the use of salivary cotinine to assess the validity of participants self-report regarding tobacco use the use of unannounced 24 hour dietary recalls the use of pedometer to assess physical activity autonomic activity eg the wide range of indices available through the use of impedance cardiography the use of heart rate variability baroreceptor sensitivity and platelet activity
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2P01HL040962 | NIH | None | httpsreporternihgovquickSearch2P01HL040962 |