Interpersonal psychotherapy (IPT) and citalopram for depression in coronary artery disease
| ISRCTN | ISRCTN15858091 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15858091 |
| Secondary identifying numbers | MCT-50397 |
- Submission date
- 17/08/2005
- Registration date
- 17/08/2005
- Last edited
- 26/02/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr François Lesperance
Scientific
Scientific
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
| Phone | +1 514 890 8000 ext. 15570 |
|---|---|
| francois.lesperance@umontreal.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A randomised, controlled trial of interpersonal psychotherapy (IPT) and citalopram for depression in coronary artery disease |
| Study acronym | CREATE |
| Study objectives | 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(s) | Institut de Cardiologie de Montréal Ethics Committee gave approval on the 30th July 2001. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/04/2002 |
| Completion date | 01/04/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 280 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2002 |
| Date of final enrolment | 01/04/2006 |
Locations
Countries of recruitment
- Canada
Study participating centre
Chief
Montreal, Quebec
H2L 4M1
Canada
H2L 4M1
Canada
Sponsor information
Montreal Heart Institute Research Center (Canada)
Research organisation
Research organisation
5000 est, rue Bélanger
Montreal, Quebec
H1T 1C8
Canada
| Phone | +1 514 376 3330 ext. 3515 |
|---|---|
| jacqueline.loiselle@icm-mhi.org | |
| Website | http://www.icm-mhi.org/en/index.html |
"ROR" |
https://ror.org/03vs03g62 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-50397)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | design and rationale | 01/01/2006 | Yes | No | |
| Results article | results | 24/01/2007 | Yes | No | |
| Results article | biomarker sub-study results | 01/01/2009 | Yes | No |
