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

Hopital Jean Minjoz

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: Escitalopram

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00243477

05-395

Details and patient eligibility

About

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

Full 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.

Enrollment: 368 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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368 participants in 2 patient groups, including a placebo group

Treatment

Active Comparator group

Description:

Escitalopram given

Treatment:

Drug: Escitalopram

Placebo

Placebo Comparator group

Description:

Placebo given

Treatment:

Drug: Escitalopram