|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Bispebjerg Hospital |
|---|---|
| Collaborators: |
H. Lundbeck A/S The Danish Heart Association The Danish Medical Research Council |
| Information provided by: | Bispebjerg Hospital |
| ClinicalTrials.gov Identifier: | NCT00140257 |
Purpose
Objective: To evaluate the efficacy of preventive treatment with a selective serotonin reuptake inhibitor (SSRI) (escitalopram) in the first year after acute coronary syndromes (ACS).
Methods: 240 patients with acute coronary syndromes (ST-elevation myocardial infarction [STEMI]), non-STEMI or unstable angina) will be enrolled within 8 weeks after ACS and will be randomly assigned to treatment with escitalopram/placebo (5-20 mg) in 52 weeks. Primary outcome measures are the diagnosis of depression and HDS (Hamilton Depression Scale). Psychiatric measurements: SCAN (Schedules for Clinical Assessment in Neuropsychiatry), HDS, HAS (Hamilton Anxiety Rating Scale), Udvalg for Kliniske Undersogelser (UKU) Side Effect Rating Scale, ESSI (Enhancing Recovery in Coronary Heart Disease [ENRICHD] Social Support Instrument), SF-36 (Short Form-36 Health Survey), SCL-92 (Symptom Check List) and BDI (Beck´s Depression Inventory). Cardiological measurements are blood pressure, electrocardiography, echocardiography (left ventricular ejection fraction), heart rate variability and use of medicine.
Discussion: ACS patients with mental illness are usually only diagnosed to a very small extent during admission in a cardiologic department. These patients mainly remain untreated with an increased risk of somatic comorbidity and mortality. Therefore, it is in accordance with ethical principles to conduct a double blind, placebo-controlled study investigating the interface between anxiety, depression and ACS. Even in this blinded study, where one of the groups are treated with placebo, there will be a higher degree of treatment of depressive symptoms due to the low recognition of this problem.
Conclusion: The DECARD study is the first study evaluating the effect of prophylactic treatment of depression in patients with ACS. The study will show if prophylactic treatment will improve cardiac prognosis.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression |
Drug: Escitalopram |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Double-Blind, Placebo-Controlled Study of Escitalopram in the Prevention of Depression in Patients With Acute Coronary Syndrome |
| Enrollment: | 240 |
| Study Start Date: | November 2004 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Denmark | |
| Bispebjerg University Hospital | |
| Copenhagen, Denmark, 2400 NV | |
| Study Director: | Morten Birket-Smith, MD, DMSci | Psychiatric Centre Bispebjerg, Bispebjerg University Hospital |
More Information
| Study ID Numbers: | KF 12-134/04 |
| Study First Received: | August 30, 2005 |
| Last Updated: | December 30, 2008 |
| ClinicalTrials.gov Identifier: | NCT00140257 History of Changes |
| Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
|
Myocardial Infarction |
|
Parasympatholytics Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Anti-Dyskinesia Agents Myocardial Ischemia Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Cholinergic Agents Pathologic Processes Mental Disorders Syndrome Therapeutic Uses |
Cardiovascular Diseases Antidepressive Agents, Second-Generation Dexetimide Antidepressive Agents Heart Diseases Disease Depression Vascular Diseases Depressive Disorder Serotonin Uptake Inhibitors Citalopram Pharmacologic Actions Behavioral Symptoms Muscarinic Antagonists Serotonin Agents |