Contact information
Type
Scientific
Primary contact
Dr François Lesperance
ORCID ID
Contact details
Chief
Department of Psychiatry
Centre Hospitalier de l'Université de Montréal
Hôpital Notre-Dame
1560 Sherbrooke E
Pavillon Mailloux
M-3234
Montreal
Quebec
H2L 4M1
Canada
+1 514 890 8000 ext. 15570
francois.lesperance@umontreal.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-50397
Study information
Scientific title
A randomised, controlled trial of interpersonal psychotherapy (IPT) and citalopram for depression in coronary artery disease
Acronym
CREATE
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
Ethics approval
Institut de Cardiologie de Montréal Ethics Committee gave approval on the 30th July 2001.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Major depression
Intervention
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.
Intervention type
Drug
Phase
Not Applicable
Drug names
Citalopram
Primary outcome measure
The 24-item HAM-D administered centrally by phone at baseline, 6- and 12-weeks.
Secondary outcome measures
The self-report Beck Depression Inventory (BDI-II) administered at baseline, 6- and 12-weeks.
Overall trial start date
01/04/2002
Overall trial end date
01/04/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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 physicians clinical judgement
5. Provision of informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
280
Participant 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. Investigators judgment that a patient is unable or unwilling to comply with the study regimen
Recruitment start date
01/04/2002
Recruitment end date
01/04/2006
Locations
Countries of recruitment
Canada
Trial participating centre
Chief
Montreal, Quebec
H2L 4M1
Canada
Sponsor information
Organisation
Montreal Heart Institute Research Center (Canada)
Sponsor details
5000 est
rue Bélanger
Montreal
Quebec
H1T 1C8
Canada
+1 514 376 3330 ext. 3515
jacqueline.loiselle@icm-mhi.org
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-50397)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
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
Publication citations
-
Design and rationale
Frasure-Smith N, Koszycki D, Swenson JR, Baker B, van Zyl LT, Laliberté MA, Abramson BL, Lambert J, Gravel G, Lespérance F, Design and rationale for a randomized, controlled trial of interpersonal psychotherapy and citalopram for depression in coronary artery disease (CREATE)., Psychosom Med, 68, 1, 87-93, doi: 10.1097/01.psy.0000195833.68482.27.
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Results
Lespérance F, Frasure-Smith N, Koszycki D, Laliberté MA, van Zyl LT, Baker B, Swenson JR, Ghatavi K, Abramson BL, Dorian P, Guertin MC, , Effects of citalopram and interpersonal psychotherapy on depression in patients with coronary artery disease: the Canadian Cardiac Randomized Evaluation of Antidepressant and Psychotherapy Efficacy (CREATE) trial., JAMA, 2007, 297, 4, 367-379, doi: 10.1001/jama.297.4.367.
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van Zyl LT, Lespérance F, Frasure-Smith N, Malinin AI, Atar D, Laliberté MA, Serebruany VL, Platelet and endothelial activity in comorbid major depression and coronary artery disease patients treated with citalopram: the Canadian Cardiac Randomized Evaluation of Antidepressant and Psychotherapy Efficacy Trial (CREATE) biomarker sub-study., J. Thromb. Thrombolysis, 2009, 27, 1, 48-56, doi: 10.1007/s11239-007-0189-3.