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

Sponsors and Collaborators:	Hopital Jean Minjoz H. Lundbeck A/S
Information provided by:	Hopital Jean Minjoz
ClinicalTrials.gov Identifier:	NCT00243477

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 Artery Bypass Surgery Coronary Artery Disease Surgery

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

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

Further study details as provided by Hopital Jean Minjoz:

Primary Outcome Measures:

All cause mortality [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: Yes ]
All cause morbidity [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Quality of life [ Time Frame: preoperatively and 1,3,6, and 12 months post-operatively ] [ Designated as safety issue: Yes ]
Beck depression index [ Time Frame: preoperatively, and 1,3,6, and 12 months post-operatively. ] [ Designated as safety issue: Yes ]

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	Drug: Escitalopram Escitalopram 10mg or placebo once a day
Placebo: Placebo Comparator Placebo given	Drug: Escitalopram Escitalopram 10mg or placebo once a day

Detailed 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.

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00243477

Contacts

Contact: Sidney Chocron, Prof.

+33381668662

sidney.chocron@univ-fcomte.fr

Locations

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

Sponsors and Collaborators

Hopital Jean Minjoz

H. Lundbeck A/S

Investigators

Study Chair:

Sidney Chocron, Prof

Department of Cardiac Surgery - Besancon - France

More Information

No publications provided

Responsible Party:	Universite de Franche Comte ( Prof. Sidney Chocron )
Study ID Numbers:	05-395
Study First Received:	October 20, 2005
Last Updated:	July 30, 2008
ClinicalTrials.gov Identifier:	NCT00243477 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Hopital Jean Minjoz:

Coronary Artery Bypass
Surgery

Study placed in the following topic categories:

Arterial Occlusive Diseases
Neurotransmitter Agents
Heart Diseases
Cholinergic Antagonists
Myocardial Ischemia
Psychotropic Drugs
Vascular Diseases
Ischemia
Arteriosclerosis
Cholinergic Agents

Serotonin Uptake Inhibitors
Citalopram
Serotonin
Coronary Disease
Muscarinic Antagonists
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Dexetimide
Antidepressive Agents
Coronary Artery Disease

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Myocardial Ischemia
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Arteriosclerosis
Cholinergic Agents
Therapeutic Uses
Cardiovascular Diseases
Dexetimide

Antidepressive Agents, Second-Generation
Antidepressive Agents
Arterial Occlusive Diseases
Heart Diseases
Vascular Diseases
Serotonin Uptake Inhibitors
Citalopram
Pharmacologic Actions
Coronary Disease
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Coronary Artery Disease

ClinicalTrials.gov processed this record on May 07, 2009