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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00243477
Recruitment Status : Completed
First Posted : October 24, 2005
Last Update Posted : March 19, 2012
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Prof. Sidney Chocron, Hopital Jean Minjoz

Tracking Information
First Submitted Date  ICMJE October 20, 2005
First Posted Date  ICMJE October 24, 2005
Last Update Posted Date March 19, 2012
Study Start Date  ICMJE January 2006
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2012)
Postoperative morbi-mortality [ Time Frame: 6 months and 1 year ]
(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
Original Primary Outcome Measures  ICMJE
 (submitted: October 20, 2005)
  • All cause mortality at 6 months and 1 year
  • All cause morbidity at 6 months and 1 year
Change History Complete list of historical versions of study NCT00243477 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2012)
  • Quality of life measured by SF-36 [ Time Frame: preoperatively and 1,3,6, and 12 months post-operatively ]
    Influence of treatment on Quality of Life after surgery
  • Beck depression index (BDI) and Center for Epidemiologic Studies Depression (CES-D) Scale [ Time Frame: preoperatively, and 1,3,6, and 12 months post-operatively. ]
    Morbi-mortaity and quality of life according to preoperative values of BDI and/or CES-D
Original Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2005)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MOTIV Study- Effect of Antidepressive Treatment by Escitalopram in Patients Undergoing Coronary Artery Bypass Grafting
Official Title  ICMJE MOTIV Study. Effect of Antidepressive Treatment by Escitalopram Started Preoperatively in Patients Undergoing Coronary Artery Bypass Grafting
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE Drug: Escitalopram
Escitalopram 10mg or placebo once a day
Other Name: Seroplex
Study Arms  ICMJE
  • Active Comparator: Treatment
    Escitalopram given
    Intervention: Drug: Escitalopram
  • Placebo Comparator: Placebo
    Placebo given
    Intervention: Drug: Escitalopram
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 16, 2012)
368
Original Enrollment  ICMJE
 (submitted: October 20, 2005)
400
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00243477
Other Study ID Numbers  ICMJE 05-395
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Sidney Chocron, Hopital Jean Minjoz
Study Sponsor  ICMJE Hopital Jean Minjoz
Collaborators  ICMJE H. Lundbeck A/S
Investigators  ICMJE
Study Chair: Sidney Chocron, Prof Department of Cardiac Surgery - Besancon - France
PRS Account Hopital Jean Minjoz
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP