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Design and Rationale for a Randomized, Controlled Trial of Interpersonal Psychotherapy and Citalopram for Depression in Coronary Artery Disease (CREATE)

From the Department of Psychiatry, McGill University, Montreal Canada (N.F.-S., F.L.); Department of Psychiatry, University of Montreal, Montreal, Canada (N.F.-S., M.-A.L., F.L.); Department of Psychiatry, University of Ottawa, Ottawa, Canada (D.K., J.R.S.); Department of Psychiatry, University of Toronto, Toronto, Canada (B.B.); Department of Psychiatry, Queen’s University, Kingston, Canada (T.v.Z.); Montreal Heart Institute Research Center, Canada (N.F.-S., M.-A.L., G.G., F.L.); Center Hospitalier de l’Université de Montreal Research Center, Montreal, Canada (N.F.-S., F.L.); School of Nursing, McGill University, Montreal, Canada (N.F.-S.); Institute of Mental Health Research, Royal Ottawa Hospital, Ottawa, Canada (D.K., J.R.S.); University of Ottawa Heart Institute, Ottawa, Canada (J.R.S.); Division of Cardiology, St. Michael’s Hospital, University of Toronto, Toronto, Canada (B.L.A.); and Department of Social and Preventive Medicine, University of Montreal, Montreal, Canada (J.L.).

Address correspondence and reprint requests to Nancy Frasure-Smith, PhD, Montreal Heart Institute Research Center, 5000 Bélanger, Montreal, Quebec H1T 1C8, Canada. E-mail: nancy.frasure-Smith{at}mcgill.ca

Objective: Recognition that depression is associated with increased morbidity and mortality in coronary artery disease (CAD) patients has augmented the need for evidence-based treatment guidelines. This article presents the design of a multisite, Canadian trial of the efficacy, safety, and tolerability of interpersonal psychotherapy (IPT), an empirically supported, depression-focused therapy, and the selective serotonin reuptake inhibitor citalopram, alone or in combination, in the treatment of major depression in CAD patients.

Methods: Two hundred eighty stable CAD patients with a current major depressive episode of at least 4 weeks’ duration, based on the Structured Clinical Interview for Depression (SCID), and who have a baseline score >19 on a centralized, telephone-administered, 24-item Hamilton Depression Rating Scale (HAM-D) will be 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 to 40 mg per day of citalopram or pill-placebo. This results in a 2-by-2 factorial design with four groups: IPT plus pill-placebo, IPT plus citalopram, CM plus pill-placebo, and CM plus citalopram. This permits the evaluation of both IPT and citalopram. Blinded, centralized, 24-item, HAM-D telephone ratings constitute the primary outcome variable. The self-report Beck Depression Inventory-II is the secondary outcome. Analyses will involve the intent-to-treat principle with last observation carried forward for incomplete assessments.

Results: Not applicable.

Conclusions: The results of this trial will contribute to the development of evidence-based clinical guidelines for managing depression in the context of CAD.

Key Words: psychotherapy • selective serotonin reuptake inhibitor • 2-by-2 factorial • telephone assessment • clinical trial • coronary artery disease

Abbreviations: CREATE = Canadian Cardiac Randomized Evaluation of Antidepressant and Psychotherapy Efficacy; IPT = interpersonal psychotherapy; CAD = coronary artery disease; SCID = Structured Clinical Interview for Depression; HAM-D = Hamilton Depression Rating Scale; CM = clinical management; SADHART = Sertraline Antidepressant Heart Attack Randomized Trial; ENRICHD = Enhancing Recovery in Coronary Heart Disease; SSRI = selective serotonin reuptake inhibitor; ECG = electrocardiogram; NIMH = National Institute of Mental Health; TDCRP = Treatment of Depression Collaborative Research Program; MMSE = Mini-mental Status Exam; STAR*D = Sequenced Treatment Alternatives to Relieve Depression; IDS = Inventory for Depressive Symptomatology; BDI-II = Beck Depression Inventory-II; IPRI = Interpersonal Relationship Inventory; FPI = Functional Performance Inventory; SAE = serious adverse event; LOCF = last observation carried forward; DSMB = data safety monitoring board.

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