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NCT Number: NCT00243477

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

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sidney Chocron

Besançon, Doubs, 25000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Escitalopram

Drug

Escitalopram 10mg or placebo once a day

Other names: Seroplex

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Hopital Jean Minjoz

Other

Collaborators

  • H. Lundbeck A/S

Registry information

Official study title

MOTIV Study. Effect of Antidepressive Treatment by Escitalopram Started Preoperatively in Patients Undergoing Coronary Artery Bypass Grafting

Important dates

Study start
2006
Primary completion
2011
Study completion
2012
First posted
Oct 24, 2005
Registry last updated
Mar 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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