Cardiovascular DiseasesNCT00217828
Effects of Citalopram on Hostility and CHD Risk
A study testing citalopram in people with Cardiovascular Diseases and Heart Diseases, run by University of Pittsburgh.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases
- What is being tested?
- citalopram
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Mar 2002to Feb 2003
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
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).
Read the 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.
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Being tested
- citalopram
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
citalopramDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMar 2002
- Primary completionFeb 2003
- Study completionFeb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Thomas Kamarck (subproject PI), University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00217828
- Sponsor's protocol ID
- 290
- Other IDs
- 2P01HL040962
- Status last verified
- Jun 2014
- First submitted
- 19 Sep 2005
- Last updated
- 11 Jun 2014
- Results posted
- No
Publications
Rice E, Vize C, Manuck S, Kamarck T. Mood reactivity to daily social conflict in hostile adults: An experimental intervention. Health Psychol. 2025 May;44(5):436-445. doi: 10.1037/hea0001411.
PubMed 40232779Kamarck TW, Muldoon MF, Manuck SB, Haskett RF, Cheong J, Flory JD, Vella E. Citalopram improves metabolic risk factors among high hostile adults: results of a placebo-controlled intervention. Psychoneuroendocrinology. 2011 Aug;36(7):1070-9. doi: 10.1016/j.psyneuen.2011.01.005. Epub 2011 Feb 8.
PubMed 21306829
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Citalopram on Hostility and CHD Risk
- ClinicalTrials.gov ID
- NCT00217828
- Acronym / sponsor ID
- 290
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2002
- Primary completion
- Feb 2003 (actual)
- Study completion
- Feb 2003 (actual)
- First posted
- 22 Sep 2005 (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.
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 (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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| citalopram | Drug | – |
Primary outcome
Not reported in the source record.
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 11 Jun 2014.
- Derived from this study: PubMed 40232779Rice E, Vize C, Manuck S, Kamarck T. Mood reactivity to daily social conflict in hostile adults: An experimental intervention. Health Psychol. 2025 May;44(5):436-445. doi: 10.1037/hea0001411.
- Derived from this study: PubMed 21306829Kamarck TW, Muldoon MF, Manuck SB, Haskett RF, Cheong J, Flory JD, Vella E. Citalopram improves metabolic risk factors among high hostile adults: results of a placebo-controlled intervention. Psychoneuroendocrinology. 2011 Aug;36(7):1070-9. doi: 10.1016/j.psyneuen.2011.01.005. Epub 2011 Feb 8.
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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.
Thomas Kamarck (subproject PI)
University of Pittsburgh
Questions about this trial
What is this clinical trial studying?
A study testing citalopram in people with Cardiovascular Diseases and Heart Diseases, run by University of Pittsburgh.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00217828, which also lists 2 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 11 Jun 2014.