This trial is active, not recruiting.

Condition depression
Treatment escitalopram
Phase phase 4
Sponsor Bispebjerg Hospital
Collaborator H. Lundbeck A/S
Start date November 2004
End date December 2008
Trial size 240 participants
Trial identifier NCT00140257, KF 12-134/04


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose prevention

Primary Outcomes

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

Secondary Outcomes

Cardiac status
time frame:
Medical comorbidity
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Double-Blind, Placebo-Controlled Study of Escitalopram in the Prevention of Depression in Patients With Acute Coronary Syndrome
Trial information was received from ClinicalTrials.gov and was last updated in December 2008.
Information provided to ClinicalTrials.gov by Bispebjerg Hospital.