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Interpersonal psychotherapy (IPT) and citalopram for depression in coronary artery disease
ISRCTN ISRCTN15858091
DOI 10.1186/ISRCTN15858091
ClinicalTrials.gov identifier
EudraCT number
Public title Interpersonal psychotherapy (IPT) and citalopram for depression in coronary artery disease
Scientific title A randomised, controlled trial of interpersonal psychotherapy (IPT) and citalopram for depression in coronary artery disease
Acronym CREATE
Serial number at source MCT-50397
Study hypothesis 1. To determine whether 12 weeks of treatment with IPT is more effective than 12 weeks of clinical management in reducing depressive symptoms
2. To determine if 12 weeks of citalopram is more effective than placebo in reducing depressive symptoms
3. To report data on the tolerability and the safety of each treatment in comparison to the control condition
Lay summary
Ethics approval Institut de Cardiologie de Montréal Ethics Committee gave approval on the 30th July 2001.
Study design Randomised controlled trial
Countries of recruitment Canada
Disease/condition/study domain Major depression
Participants - inclusion criteria Persons of either sex in age groups: 18 years and above.
1. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of current major depressive episode based on the Structured Clinical Interview for Depression (SCID) with at least 4 weeks duration
2. Baseline score greater than 19 on the centralized, telephone-administered 24-item, Hamilton Depression Rating Scale (HAM-D)
3. Evidence of coronary artery disease (CAD) based on hospital chart evidence of a previous hospitalization for acute myocardial infarction, or coronary angiographic evidence of greater than 50% blockage in at least one major coronary artery, or prior revascularization
4. Stable CAD based on physician’s clinical judgement
5. Provision of informed consent
Participants - exclusion criteria 1. Less than 18 years of age
2. Coronary bypass surgery planned during the next 4 months
3. Canadian Cardiovascular Society Angina Class (CCS) = 4
4. SCID documented bipolar disorder, major depression with psychotic features or evidence of substance abuse or dependency during the previous 12 months
5. Serious suicide or risk based on clinical judgment
6. Use of anti-depressants, lithium or anti-convulsants for mood disorder
7. Currently undergoing any form of psychotherapy
8. Absence of response to a previous adequate trial of citalopram or IPT
9. Two previous unsuccessful trials of treatment for depression for the index episode
10. Lifetime history of early termination (less than 8 weeks) of citalopram because of adverse events or side-effects
11. Lifetime history of early termination (less than 8 weeks) of two other selective serotonin reuptake inhibitor (SSRI) antidepressants (paroxetine, fluoxetine, fluvoxamine, sertraline) because of adverse events or side-effects
12. Significant cognitive problems (Mini-Mental Status Exam [MMSE] less than 24)
13. Depression due to a general medical condition based on clinical judgment
14. Participation in other trials
15. Inability to speak French or English
16. Investigator’s judgment that a patient is unable or unwilling to comply with the study regimen
Anticipated start date 01/04/2002
Anticipated end date 01/04/2006
Status of trial Completed
Patient information material
Target number of participants 280
Interventions Participants are randomly assigned to receive 12 weekly IPT sessions or 12 weekly sessions of standardized clinical management (CM). Patients are also randomly assigned to receive 20-40 mg per day of citalopram or pill-placebo. This results in four groups:
Group 1 receives IPT plus CM and citalopram
Group 2 receives IPT plus CM and placebo
Group 3 receives CM and citalopram
Group 4 receives CM and placebo

Patients in all 4 groups take part in weekly, individual CM sessions involving a brief structured review of side effects and progress that lasts 15 to 20 minutes. These sessions are administered by the IPT therapists, who have been trained to evaluate side effects and cardiac symptoms, and are supervised by the site principal investigators. In groups 1 and 2, IPT is administered over 40 to 60 minutes on a weekly basis by a certified IPT therapist who follows the treatment manual developed by Klerman et al. The intervention was slightly adapted to meet the needs of depressed CAD patients, including a 12 week duration of therapy instead of the usual 16 weeks to decrease the time maintaining patients on a placebo, and also to decrease the study burden on patients in order to maximize the rate of treatment completion. IPT sessions immediately follow structured CM. To facilitate participation in the intended 12 IPT sessions, up to 4 sessions may be conducted by telephone if needed.
Primary outcome measure(s) The 24-item HAM-D administered centrally by phone at baseline, 6- and 12-weeks.
Secondary outcome measure(s) The self-report Beck Depression Inventory (BDI-II) administered at baseline, 6- and 12-weeks.
Sources of funding Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-50397)
Trial website
Publications 1. 2006 design and rationale in http://www.ncbi.nlm.nih.gov/pubmed/16449416
2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17244833
3. 2009 biomarker sub-study results in http://www.ncbi.nlm.nih.gov/pubmed/18188512
Contact name Dr  François   Lesperance
  Address Chief
Department of Psychiatry
Centre Hospitalier de l'Université de Montréal
Hôpital Notre-Dame
1560 Sherbrooke E
Pavillon Mailloux, M-3234
  City/town Montreal, Quebec
  Zip/Postcode H2L 4M1
  Country Canada
  Tel +1 514 890 8000 ext. 15570
  Fax +1 514 412 7859
  Email francois.lesperance@umontreal.ca
Sponsor Montreal Heart Institute Research Center (Canada)
  Address 5000 est, rue Bélanger
  City/town Montreal, Quebec
  Zip/Postcode H1T 1C8
  Country Canada
  Tel +1 514 376 3330 ext. 3515
  Fax +1 514 593 2540
  Email jacqueline.loiselle@icm-mhi.org
  Sponsor website: http://www.icm-mhi.org/en/index.html
Date applied 17/08/2005
Last edited 26/02/2009
Date ISRCTN assigned 17/08/2005
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