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

Hopital Jean Minjoz368 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

368

Conditions

Coronary Artery Disease

Interventions

EscitalopramDRUG

Escitalopram 10mg or placebo once a day

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

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

Locations (1)

Sidney Chocron

Besançon, Doubs, France

Outcomes

Primary Outcomes

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

Time frame: 6 months and 1 year

Secondary Outcomes

Quality of life measured by SF-36

Influence of treatment on Quality of Life after surgery

Time frame: 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

Time frame: preoperatively, and 1,3,6, and 12 months post-operatively.

Data from ClinicalTrials.gov

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