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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00243477
• Other study ID #: 05-395
• Status: Completed
• Phase: Phase 4
• First received: October 20, 2005
• Last updated: March 16, 2012
• Start date: January 2006
• Est. completion date: February 2012

Study information

• Verified date: March 2012
• Source: Hopital Jean Minjoz
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 368
• Est. completion date: February 2012
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Escitalopram
Escitalopram 10mg or placebo once a day

Locations

Country	Name	City	State
France	Sidney Chocron	Besançon	Doubs

Sponsors (2)

Lead Sponsor	Collaborator
Hopital Jean Minjoz	H. Lundbeck A/S

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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.	No