DECARD: Study of Escitalopram in the Prevention of Depression in Patients With Acute Coronary Syndrome - Tabular View

Tracking Information

First Received Date ^ICMJE

August 30, 2005

Last Updated Date

December 30, 2008

Start Date ^ICMJE

November 2004

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Hamilton Depression Scale
International Classification of Diseases, Revision 10 (ICD-10) Mood Disorder Diagnosis

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00140257 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Cardiac status
Medical comorbidity

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

DECARD: Study of Escitalopram in the Prevention of Depression in Patients With Acute Coronary Syndrome

Official Title ^ICMJE

A Double-Blind, Placebo-Controlled Study of Escitalopram in the Prevention of Depression in Patients With Acute Coronary Syndrome

Brief Summary

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Depression

Intervention ^ICMJE

Drug: Escitalopram

Study Arms / Comparison Groups

Publications *

Hansen BH, Hanash JA, Rasmussen A, Hansen JF, Birket-Smith M. Rationale, design and methodology of a double-blind, randomized, placebo-controlled study of escitalopram in prevention of Depression in Acute Coronary Syndrome (DECARD). Trials. 2009 Apr 7;10:20.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

240

Completion Date

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

ACS
Randomization within 8 weeks form index hospitalization for ACS
Age > 18 years
Not pregnant
Signed informed consent

Exclusion Criteria:

Current depression
Use of antidepressants < 4 weeks
Previous intolerance to SSRI
Severe medical conditions
Severe heart failure
Alcohol or substance abuse
Psychosis or dementia
Current participation in other intervention trials
Pregnancy and lactation
Linguistic difficulties

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00140257

Responsible Party

Study ID Numbers ^ICMJE

KF 12-134/04

Study Sponsor ^ICMJE

Bispebjerg Hospital

Collaborators ^ICMJE

H. Lundbeck A/S
The Danish Heart Association
The Danish Medical Research Council

Investigators ^ICMJE

Study Director:

Morten Birket-Smith, MD, DMSci

Psychiatric Centre Bispebjerg, Bispebjerg University Hospital

Information Provided By

Bispebjerg Hospital

Verification Date

December 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP