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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

368 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2012-02-29

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

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment

Escitalopram given

Group Type ACTIVE_COMPARATOR

Escitalopram

Intervention Type DRUG

Escitalopram 10mg or placebo once a day

Placebo

Placebo given

Group Type PLACEBO_COMPARATOR

Escitalopram

Intervention Type DRUG

Escitalopram 10mg or placebo once a day

Interventions

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Escitalopram

Escitalopram 10mg or placebo once a day

Intervention Type DRUG

Other Intervention Names

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Seroplex

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

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No