MOTIV Study- Effect of Antidepressive Treatment by Escitalopram in Patients Undergoing Coronary Artery Bypass Grafting

Study Overview
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Brief Summary
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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
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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.

Official Title
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MOTIV Study. Effect of Antidepressive Treatment by Escitalopram Started Preoperatively in Patients Undergoing Coronary Artery Bypass Grafting

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Escitalopram


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment<br>Escitalopram given | Drug: Escitalopram<br>* Escitalopram 10mg or placebo once a day<br>* Other names: Seroplex;|
| Placebo Comparator: Placebo<br>Placebo given | Drug: Escitalopram<br>* Escitalopram 10mg or placebo once a day<br>* Other names: Seroplex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative morbi-mortality | (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 | 6 months and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life measured by SF-36 | Influence of treatment on Quality of Life after surgery | preoperatively and 1,3,6, and 12 months post-operatively | 
| Beck depression index (BDI) and Center for Epidemiologic Studies Depression (CES-D) Scale | Morbi-mortaity and quality of life according to preoperative values of BDI and/or CES-D | preoperatively, and 1,3,6, and 12 months post-operatively. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Bypass, Surgery