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The Canadian Cardiac Randomized Evaluation of Antidepressant and Psychotherapy Efficacy (CREATE) Trial PowerPoint Presentation
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The Canadian Cardiac Randomized Evaluation of Antidepressant and Psychotherapy Efficacy (CREATE) Trial

The Canadian Cardiac Randomized Evaluation of Antidepressant and Psychotherapy Efficacy (CREATE) Trial

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The Canadian Cardiac Randomized Evaluation of Antidepressant and Psychotherapy Efficacy (CREATE) Trial

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  1. 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 François Lespérance, MD; Nancy Frasure-Smith, PhD; Diana Koszycki, PhD; Marc-André Laliberté, MD; Louis T. van Zyl, MD; Brian Baker, MBChB; John Robert Swenson, MD; Kayhan Ghatavi, MD; Beth L. Abramson, MD; Paul Dorian, MD; Marie-Claude Guertin, PhD; for the CREATE Investigators Published in JAMA, January 24, 2007

  2. CREATE Trial: Background • Few randomized controlled trials have evaluated the efficacy of treatments for major depression patients with coronary artery disease (CAD). • No previous studies have simultaneously evaluated an antidepressant and short-term psychotherapy. Lespérance et al., JAMA 2007; 297(4): 367-79

  3. CREATE Trial: Background Cont. • 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 selective serotonin reuptake inhibitor (SSRI), and interpersonal psychotherapy (IPT), a short-term, manual-based psychotherapy focusing on the social context of depression. Lespérance et al., JAMA 2007; 297(4): 367-79

  4. CREATE Trial: Study Design 284 Patients with CAD from 9 Canadian academic centers, meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for major depression > 4 weeks duration and had baseline 24-item Hamilton Depression Rating Scale (HAM-D) > 20 2X2 Factorial. Randomized. Controlled. Parallel-Group. Double-blinded. Mean age 58.2 years, 25% women R Clinical Management + IPT n=142 Clinical Management Only n=142 R R Citalopram n=67 Placebo n=75 Citalopram n=75 Placebo n=67 12 weeks • Primary Endpoint Change in 24-item HAM-D from baseline. • Secondary Endpoint: Self-reported Beck Depression Inventory II (BDI-II) score Lespérance et al., JAMA 2007; 297(4): 367-79

  5. CREATE Trial: Baseline Characteristics Lespérance et al., JAMA 2007; 297(4): 367-79

  6. CREATE Trial: Primary Endpoint 24-item HAM-D score at follow up for Citalopram vs. Placebo • Citalopram was superior in reducing 12-week HAM-D scores (mean difference=3.3 points, p=0.005) vs. placebo. • There was no significant difference in mean HAM-D scores for clinical management vs. IPT. p = 0.005 24-item HAM-D score (mean) n = 142 n = 142 Lespérance et al., JAMA 2007; 297(4): 367-79

  7. CREATE Trial: Secondary Endpoint BDI-II score at follow up for Citalopram vs. Placebo • Citalopram was superior in reducing BDI-II scores (mean difference=3.6 points, p=0.005) vs. placebo. • There was no significant difference in BDI-II scores for clinical management vs. IPT. p = 0.005 BDI-II score (mean) n = 142 n = 142 Lespérance et al., JAMA 2007; 297(4): 367-79

  8. CREATE Trial: Limitations • Recruitment of participants through advertisements and exclusion of those unwilling to accept randomization, both of which reduced the generalizability of results. • Even though most analyses were preplanned, some significant differences may have occurred by chance. Lespérance et al., JAMA 2007; 297(4): 367-79

  9. CREATE Trial: Limitations Cont. • By chance, more women were randomized to receive IPT than clinical management alone; however, there was no difference between men and women in their responses to citalopram/placebo or IPT/clinical management. Lespérance et al., JAMA 2007; 297(4): 367-79

  10. CREATE Trial: Summary • CREATE trial documents the efficacy of citalopram administered in conjunction with weekly clinical management for patients with CAD. • There is, however, no evidence of added value of IPT over clinical management. Lespérance et al., JAMA 2007; 297(4): 367-79

  11. CREATE Trial: Summary • Based on this trial and previous studies, citalopram or sertraline in addition to clinical management should be considered as a first-step treatment for patients with CAD and major depression. Lespérance et al., JAMA 2007; 297(4): 367-79