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François Lespérance,
Nancy Frasure-Smith,
Diana Koszycki,
Marc-André Laliberté,
Louis T van Zyl,
Brian Baker,
John Robert Swenson,
Kayhan Ghatavi, Beth L Abramson,
Paul Dorian,
Marie-Claude Guertin
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[hide abstract]
ABSTRACT: Few randomized controlled trials have evaluated the efficacy of treatments for major depression in patients with coronary artery disease (CAD). None have simultaneously evaluated an antidepressant and short-term psychotherapy.
To document the short-term efficacy of a selective serotonin reuptake inhibitor (citalopram) and interpersonal psychotherapy (IPT) in reducing depressive symptoms in patients with CAD and major depression.
The Canadian Cardiac Randomized Evaluation of Antidepressant and Psychotherapy Efficacy, a randomized, controlled, 12-week, parallel-group, 2 x 2 factorial trial conducted May 1, 2002, to March 20, 2006, among 284 patients with CAD from 9 Canadian academic centers. All patients met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for diagnosis of major depression of 4 weeks' duration or longer and had baseline 24-item Hamilton Depression Rating Scale (HAM-D) scores of 20 or higher.
Participants underwent 2 separate randomizations: (1) to receive 12 weekly sessions of IPT plus clinical management (n = 142) or clinical management only (n = 142) and (2) to receive 12 weeks of citalopram, 20 to 40 mg/d (n = 142), or matching placebo (n = 142).
The primary outcome measure was change between baseline and 12 weeks on the 24-item HAM-D, administered blindly during centralized telephone interviews (tested at alpha = .033); the secondary outcome measure was self-reported Beck Depression Inventory II (BDI-II) score (tested at alpha = .017).
Citalopram was superior to placebo in reducing 12-week HAM-D scores (mean difference, 3.3 points; 96.7% confidence interval [CI], 0.80-5.85; P = .005), with a small to medium effect size of 0.33. Mean HAM-D response (52.8% vs 40.1%; P = .03) and remission rates (35.9% vs 22.5%; P = .01) and the reduction in BDI-II scores (difference, 3.6 points; 98.3% CI, 0.58-6.64; P = .005; effect size = 0.33) also favored citalopram. There was no evidence of a benefit of IPT over clinical management, with the mean HAM-D difference favoring clinical management (-2.26 points; 96.7% CI, -4.78 to 0.27; P = .06; effect size, 0.23). The difference on the BDI-II did not favor clinical management (1.13 points; 98.3% CI, -1.90 to 4.16; P = .37; effect size = 0.11).
This trial documents the efficacy of citalopram administered in conjunction with weekly clinical management for major depression among patients with CAD and found no evidence of added value of IPT over clinical management. Based on these results and those of previous trials, citalopram or sertraline plus clinical management should be considered as a first-step treatment for patients with CAD and major depression.
isrctn.org Identifier: ISRCTN15858091.
JAMA The Journal of the American Medical Association 02/2007; 297(4):367-79. · 30.03 Impact Factor
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ABSTRACT: 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.
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.
Not applicable.
The results of this trial will contribute to the development of evidence-based clinical guidelines for managing depression in the context of CAD.
Psychosomatic Medicine 68(1):87-93. · 3.97 Impact Factor
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François Lespérance,
Nancy Frasure-Smith,
Diana Koszycki,
Marc-André Laliberté,
Louis T. van Zyl,
Brian Baker,
John Robert Swenson,
Kayhan Ghatavi, Beth L. Abramson,
Paul Dorian,
Marie-Claude Guertin,
for the CREATE Investigators
[show abstract]
[hide abstract]
ABSTRACT: Context
Few randomized controlled trials have evaluated the efficacy of treatments for major depression in patients with coronary artery disease (CAD). None have simultaneously evaluated an antidepressant and short-term psychotherapy.Objective
To document the short-term efficacy of a selective serotonin reuptake inhibitor (citalopram) and interpersonal psychotherapy (IPT) in reducing depressive symptoms in patients with CAD and major depression.Design, Setting, and Participants
The Canadian Cardiac Randomized Evaluation of Antidepressant and Psychotherapy Efficacy, a randomized, controlled, 12-week, parallel-group, 2 × 2 factorial trial conducted May 1, 2002, to March 20, 2006, among 284 patients with CAD from 9 Canadian academic centers. All patients met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for diagnosis of major depression of 4 weeks' duration or longer and had baseline 24-item Hamilton Depression Rating Scale (HAM-D) scores of 20 or higher.Interventions
Participants underwent 2 separate randomizations: (1) to receive 12 weekly sessions of IPT plus clinical management (n = 142) or clinical management only (n = 142) and (2) to receive 12 weeks of citalopram, 20 to 40 mg/d (n = 142), or matching placebo (n = 142).Main Outcome Measures
The primary outcome measure was change between baseline and 12 weeks on the 24-item HAM-D, administered blindly during centralized telephone interviews (tested at α = .033); the secondary outcome measure was self-reported Beck Depression Inventory II (BDI-II) score (tested at α = .017).Results
Citalopram was superior to placebo in reducing 12-week HAM-D scores (mean difference, 3.3 points; 96.7% confidence interval [CI], 0.80-5.85; P = .005), with a small to medium effect size of 0.33. Mean HAM-D response (52.8% vs 40.1%; P = .03) and remission rates (35.9% vs 22.5%; P = .01) and the reduction in BDI-II scores (difference, 3.6 points; 98.3% CI, 0.58-6.64; P = .005; effect size = 0.33) also favored citalopram. There was no evidence of a benefit of IPT over clinical management, with the mean HAM-D difference favoring clinical management (−2.26 points; 96.7% CI, −4.78 to 0.27; P = .06; effect size, 0.23). The difference on the BDI-II did not favor clinical management (1.13 points; 98.3% CI, −1.90 to 4.16; P = .37; effect size = 0.11).Conclusions
This trial documents the efficacy of citalopram administered in conjunction with weekly clinical management for major depression among patients with CAD and found no evidence of added value of IPT over clinical management. Based on these results and those of previous trials, citalopram or sertraline plus clinical management should be considered as a first-step treatment for patients with CAD and major depression.Trial Registration
isrctn.org Identifier: ISRCTN15858091
Figures in this Article
Since the early 1990s, studies have reported prevalences of major depression between 17% and 27% in hospitalized patients with coronary artery disease (CAD).1 Most have also demonstrated that depression has a negative cardiac prognostic impact.2- 3 Only 1 large randomized trial, the Enhancing Recovery in Coronary Heart Disease (ENRICHD) study,4 has tried to determine whether treating depression could improve cardiac prognosis in CAD patients. Although ENRICHD demonstrated that a combination of short-term individual cognitive behavior therapy (CBT) and a selective serotonin reuptake inhibitor (SSRI), when needed, was significantly better than usual care at reducing depressive symptoms over 6 months in depressed or socially isolated myocardial infarction patients, the effect size was small. The study failed to show that the ENRICHD treatment protocol was better than usual care in preventing all-cause mortality and recurrent myocardial infarctions.
While there is a clear need for additional studies evaluating interventions to prevent the cardiac prognostic impact of depression,5- 6 there have also been few adequately controlled trials evaluating whether depression treatments are effective in reducing depressive symptoms in patients with CAD.7- 8 The largest of these, the Sertraline Antidepressant Heart Attack Trial (SADHART),8 provided some evidence of the safety of sertraline in patients recently hospitalized for an acute coronary syndrome. However, the overall efficacy results were less convincing. Planned subgroup analyses showed a clear benefit of sertraline over placebo for patients with recurrent depression and those with more severe depression. Additional post hoc analyses showed that patients whose depression began before the index cardiac event benefited more from sertraline than those with more recent depression onset.9
The Canadian Cardiac Randomized Evaluation of Antidepressant and Psychotherapy Efficacy (CREATE) is the first trial specifically designed to evaluate the short-term efficacy and tolerability of 2 depression treatments in patients with CAD: citalopram, a first-line SSRI antidepressant10 and interpersonal psychotherapy (IPT),11 a short-term, manual-based psychotherapy focusing on the social context of depression. To help ensure the applicability of results to a wide group of cardiac patients, recruitment was not restricted to patients with a recent acute coronary syndrome hospitalization.
JAMA The Journal of the American Medical Association 297(4):367-379. · 30.03 Impact Factor
