MOTIV Study. Effect of Antidepressive Treatment by Escitalopram Started Preoperatively in Patients Undergoing Coronary Artery Bypass Grafting
Overview
- Phase
- Phase 4
- Intervention
- Escitalopram
- Conditions
- Coronary Artery Disease
- Sponsor
- Hopital Jean Minjoz
- Enrollment
- 368
- Locations
- 1
- Primary Endpoint
- Postoperative morbi-mortality
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
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
Detailed Description
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.
Investigators
Prof. Sidney Chocron
MD,PhD
Hopital Jean Minjoz
Eligibility Criteria
Inclusion Criteria
- •Patients undergoing elective coronary artery bypass surgery
- •\> 30 years old
Exclusion Criteria
- •Contra-indication to antidepressive treatment
- •Already treated by antidepressive treatment
- •Concomitant cardiac surgery as valve replacement etc.
- •Patients having anticoagulation therapy
- •Pregnant women
- •Hepatic insufficiency
Arms & Interventions
Treatment
Escitalopram given
Intervention: Escitalopram
Placebo
Placebo given
Intervention: Escitalopram
Outcomes
Primary Outcomes
Postoperative morbi-mortality
Time Frame: 6 months and 1 year
(1) cardiac : (2) pulmonary (3) neurologic (4) renal (5) rythm (6) infectious(7) any surgery or invasive procedure necessary to treat a postoperative adverse event associated with the initial cardiac surgery ; (8) myocardial infarction during follow-up; (9) congestive heart failure during follow-up; (10) rehospitalization for cardiac related cause, and (11) rehospitalization for non-cardiac related cause
Secondary Outcomes
- Quality of life measured by SF-36(preoperatively and 1,3,6, and 12 months post-operatively)
- Beck depression index (BDI) and Center for Epidemiologic Studies Depression (CES-D) Scale(preoperatively, and 1,3,6, and 12 months post-operatively.)