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Sponsors and Collaborators: |
Hopital Jean Minjoz H. Lundbeck A/S |
Information provided by: | Hopital Jean Minjoz |
ClinicalTrials.gov Identifier: | NCT00243477 |
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 Artery Bypass Surgery Coronary Artery Disease |
ChemIDplus related topics: | Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), 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 |
Estimated Enrollment: | 400 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Treatment: Active Comparator
Escitalopram given
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Drug: Escitalopram
Escitalopram 10mg or placebo once a day
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Placebo: Placebo Comparator
Placebo given
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Drug: Escitalopram
Escitalopram 10mg or placebo once a day
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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.
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sidney Chocron, Prof. | +33381668662 | sidney.chocron@univ-fcomte.fr |
France, Doubs | |||||
Sidney Chocron | Recruiting | ||||
Besançon, Doubs, France, 25000 | |||||
Contact: Sidney Chocron, Prof +33381668664 chocron@univ-fcomte.fr | |||||
Contact: Pierre Vandel, MD +33381214385 pvandel@chu-besancon.fr | |||||
Principal Investigator: Sidney Chocron, Prof | |||||
Sub-Investigator: Pierre Vandel, MD | |||||
Sub-Investigator: Frederic Laluc, MD | |||||
Principal Investigator: Nicolas Bischoff, MD |
Hopital Jean Minjoz |
H. Lundbeck A/S |
Study Chair: | Sidney Chocron, Prof | Department of Cardiac Surgery - Besancon - France |
Responsible Party: | Universite de Franche Comte ( Prof. Sidney Chocron ) |
Study ID Numbers: | 05-395 |
First Received: | October 20, 2005 |
Last Updated: | July 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00243477 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
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