"MOTIV" Study. Effect of Antidepressive Treatment by Escitalopram in Patients Undergoing Coronary Artery Bypass Grafting
This study is currently recruiting participants.
Verified by Hopital Jean Minjoz July 2007
Sponsors and Collaborators: |
Hopital Jean Minjoz
H. Lundbeck A/S |
Information provided by: |
Hopital Jean Minjoz |
ClinicalTrials.gov Identifier: |
NCT00243477 |
|
Purpose
The purpose of this study is to determine the effect of an antidepressive medication (Escitalopram), started preoperatively and given during 6 months, on 6-month and 1 year post-operative morbidity and mortality after coronary artery bypass grafting
Condition |
Intervention |
Phase |
Coronary Artery Disease
Surgery |
Drug: Escitalopram |
Phase IV |
MedlinePlus related topics: Coronary Artery Disease
Genetics Home Reference related topics: Coronary Artery Disease
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Number of arms in study: 2
Official Title: "MOTIV" Study. Effect of Antidepressive Treatment by Escitalopram Started Preoperatively in Patients Undergoing Coronary Artery Bypass Grafting
Primary Outcome Measures:
- All cause mortality [Time Frame: 6 months and 1 year]
- All cause morbidity [Time Frame: 6 months and 1 year]
Secondary Outcome Measures:
- Quality of life [Time Frame: preoperatively and 1,3,6, and 12 months post-operatively]
- Beck depression index [Time Frame: preoperatively, and 1,3,6, and 12 months post-operatively.]
Further study details as provided by Hopital Jean Minjoz:
Total Enrollment: 400
Study start: January 2006; Expected completion: January 2009
Depression is known to have an adverse effect on post-operative mortality and morbidity after coronary artery bypass grafting. Cardiac surgery is known to cause transient depression in patients. The purpose of this double-blind, randomized study is to determine the effect of an antidepressive medication (Escitalopram), started preoperatively and given during 6 months, on 6-month and 1 year post-operative morbidity and mortality after coronary artery bypass grafting. Treatment is given from 21 to 15 days pre-operatively until the 6th post-operative month. Morbidity as defined by the STS database as well as mortality is checked during 1 year.