Effects of Citalopram on Hostility and CHD Risk

June 10, 2014 updated by: University of Pittsburgh
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 (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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

No eligibility criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Thomas Kamarck (subproject PI), University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Primary Completion (Actual)

February 1, 2003

Study Completion (Actual)

February 1, 2003

Study Registration Dates

First Submitted

September 19, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

June 11, 2014

Last Update Submitted That Met QC Criteria

June 10, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 290
  • 2P01HL040962 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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