Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00217828 |
| Other study ID # |
290 |
| Secondary ID |
2P01HL040962 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
September 19, 2005 |
| Last updated |
June 10, 2014 |
| Start date |
March 2002 |
| Est. completion date |
February 2003 |
Study information
| Verified date |
June 2014 |
| Source |
University of Pittsburgh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Interventional
|
Clinical Trial 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).
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 (e.g., tobacco and alcohol use, imprudent diet), cardiovascular reactivity to
stressful circumstances, and physiological indices (e.g., 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 (e.g., 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 (e.g., the wide range of
indices available through the use of impedance cardiography, the use of heart rate
variability, baroreceptor sensitivity), and platelet activity.
