Not Signed In -
Coronary Artery Bypass Graft |
CABG |
Clinical Trial: "MOTIV" Study. Effect of Antidepressive Treatment by Escitalopram in Patients Undergoing Coronary Artery Bypass Grafting
"MOTIV" Study. Effect of Antidepressive Treatment by Escitalopram in Patients Undergoing Coronary Artery Bypass Grafting
This study is not yet open for patient recruitment.
Verified by Hopital Jean Minjoz October 2005
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
| Coronary Artery Disease Surgery | Drug: Escitalopram | Phase IV |
MedlinePlus related topics: Coronary Disease
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: "MOTIV" Study. Effect of Antidepressive Treatment by Escitalopram Started Preoperatively in Patients Undergoing Coronary Artery Bypass Grafting
Further study details as provided by Hopital Jean Minjoz:
Primary Outcomes: All cause mortality at 6 months and 1 year; All cause morbidity at 6 months and 1 year
Secondary Outcomes: Quality of life preoperatively, and 1,3,6, and 12 months post-operatively..; Beck depression index preoperatively, and 1,3,6, and 12 months post-operatively.
Expected Total Enrollment: 400
Secondary Outcomes: Quality of life preoperatively, and 1,3,6, and 12 months post-operatively..; Beck depression index preoperatively, and 1,3,6, and 12 months post-operatively.
Expected Total Enrollment: 400
Study start: January 2006; Expected completion: May 2009
Last follow-up: January 2009
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.
Eligibility
Ages Eligible for Study: 30 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Patients undergoing elective coronary artery bypass surgery
- >30 years old
Exclusion Criteria:
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00243477
France, Doubs
Sidney Chocron, Besançon, Doubs, 25000, France
Sidney Chocron, Prof +33381668664 chocron@ufc-chu.univ-fcomte.fr
Pierre Vandel, MD +33381214385 pvandel@chu-besancon.fr
Sidney Chocron, Prof, Principal Investigator
Pierre Vandel, MD, Sub-Investigator
Pierre Falcoz, MD, Sub-Investigator
Frederic Laluc, MD, Sub-Investigator
Pierre Vandel, MD +33381214385 pvandel@chu-besancon.fr
Sidney Chocron, Prof, Principal Investigator
Pierre Vandel, MD, Sub-Investigator
Pierre Falcoz, MD, Sub-Investigator
Frederic Laluc, MD, Sub-Investigator
Study chairs or principal investigators
More Information
Study ID Numbers: 05-395
Last Updated: December 8, 2005
Record first received: October 20, 2005
ClinicalTrials.gov Identifier: NCT00243477
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2006-01-10
Last Updated: December 8, 2005
Record first received: October 20, 2005
ClinicalTrials.gov Identifier: NCT00243477
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2006-01-10
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