MOTIV Study- Effect of Antidepressive Treatment by Escitalopram in Patients Undergoing Coronary Artery Bypass Grafting
- Registration Number
- NCT00243477
- Lead Sponsor
- Hopital Jean Minjoz
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 368
- Patients undergoing elective coronary artery bypass surgery
- > 30 years old
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Escitalopram Placebo given Treatment Escitalopram Escitalopram given
- Primary Outcome Measures
Name Time Method Postoperative morbi-mortality 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 Outcome Measures
Name Time Method Quality of life measured by SF-36 preoperatively and 1,3,6, and 12 months post-operatively Influence of treatment on Quality of Life after surgery
Beck depression index (BDI) and Center for Epidemiologic Studies Depression (CES-D) Scale preoperatively, and 1,3,6, and 12 months post-operatively. Morbi-mortaity and quality of life according to preoperative values of BDI and/or CES-D
Trial Locations
- Locations (1)
Sidney Chocron
🇫🇷Besançon, Doubs, France