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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Escitalopram
Sponsored by
Hopital Jean Minjoz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Bypass, Surgery

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sidney Chocron

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treatment

Placebo

Arm Description

Escitalopram given

Placebo given

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of life measured by SF-36
Influence of treatment on Quality of Life after surgery
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

Full Information

First Posted
October 20, 2005
Last Updated
March 16, 2012
Sponsor
Hopital Jean Minjoz
Collaborators
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00243477
Brief Title
MOTIV Study- Effect of Antidepressive Treatment by Escitalopram in Patients Undergoing Coronary Artery Bypass Grafting
Official Title
MOTIV Study. Effect of Antidepressive Treatment by Escitalopram Started Preoperatively in Patients Undergoing Coronary Artery Bypass Grafting
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hopital Jean Minjoz
Collaborators
H. Lundbeck A/S

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Artery Bypass, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
368 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Active Comparator
Arm Description
Escitalopram given
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo given
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Seroplex
Intervention Description
Escitalopram 10mg or placebo once a day
Primary Outcome Measure Information:
Title
Postoperative morbi-mortality
Description
(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
Time Frame
6 months and 1 year
Secondary Outcome Measure Information:
Title
Quality of life measured by SF-36
Description
Influence of treatment on Quality of Life after surgery
Time Frame
preoperatively and 1,3,6, and 12 months post-operatively
Title
Beck depression index (BDI) and Center for Epidemiologic Studies Depression (CES-D) Scale
Description
Morbi-mortaity and quality of life according to preoperative values of BDI and/or CES-D
Time Frame
preoperatively, and 1,3,6, and 12 months post-operatively.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sidney Chocron, Prof
Organizational Affiliation
Department of Cardiac Surgery - Besancon - France
Official's Role
Study Chair
Facility Information:
Facility Name
Sidney Chocron
City
Besançon
State/Province
Doubs
ZIP/Postal Code
25000
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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