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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.

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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

create trial background
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

create trial background cont
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

create trial study design
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

create trial baseline characteristics
CREATE Trial: Baseline Characteristics

Lespérance et al., JAMA 2007; 297(4): 367-79

create trial primary endpoint
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

create trial secondary endpoint
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

create trial limitations
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

create trial limitations cont
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

create trial summary
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

create trial summary11
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