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

This study has been completed.
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Prof. Sidney Chocron, Hopital Jean Minjoz
ClinicalTrials.gov Identifier:
NCT00243477
First received: October 20, 2005
Last updated: March 16, 2012
Last verified: March 2012
  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
Drug: Escitalopram
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: MOTIV Study. Effect of Antidepressive Treatment by Escitalopram Started Preoperatively in Patients Undergoing Coronary Artery Bypass Grafting

Resource links provided by NLM:


Further study details as provided by Hopital Jean Minjoz:

Primary Outcome Measures:
  • Postoperative morbi-mortality [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: Yes ]
    (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 [ Time Frame: preoperatively and 1,3,6, and 12 months post-operatively ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Morbi-mortaity and quality of life according to preoperative values of BDI and/or CES-D


Enrollment: 368
Study Start Date: January 2006
Study Completion Date: February 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment
Escitalopram given
Drug: Escitalopram
Escitalopram 10mg or placebo once a day
Other Name: Seroplex
Placebo Comparator: Placebo
Placebo given
Drug: Escitalopram
Escitalopram 10mg or placebo once a day
Other Name: Seroplex

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Sidney Chocron
Besançon, Doubs, France, 25000
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: Prof. Sidney Chocron, MD,PhD, Hopital Jean Minjoz
ClinicalTrials.gov Identifier: NCT00243477     History of Changes
Other Study ID Numbers: 05-395
Study First Received: October 20, 2005
Last Updated: March 16, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hopital Jean Minjoz:
Coronary Artery Bypass
Surgery

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Antidepressive Agents
Citalopram
Dexetimide
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on August 20, 2014