Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00140257
Status:
UNKNOWN
Last Update Posted:
2008-12-31
First Post:
2005-08-30
Brief Title:
DECARD Study of Escitalopram in the Prevention of Depression in Patients With Acute Coronary Syndrome
Sponsor:
Bispebjerg Hospital
Organization:
Bispebjerg Hospital
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Study of Escitalopram in the Prevention of Depression in Patients With Acute Coronary Syndrome
Status:
UNKNOWN
Status Verified Date:
2008-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 escitalopramplacebo 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 Becks 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
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 escitalopramplacebo 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 Becks 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None