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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

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

NCT ID

NCT00243477

First Posted

October 20, 2005

Last Updated

March 16, 2012

Sponsor

Hopital Jean Minjoz

Collaborators

H. Lundbeck A/S

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

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

Eligibility Criteria

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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