Level 1: Likely Reliable evidence


Level 2: Mid-level evidence

Continue Reading

The Canadian Cardiac Randomized Evaluation of Antidepressant and Psychotherapy Efficacy (CREATE) trial evaluated 284 patients with CAD who had major depression for at least four weeks and Hamilton Depression Rating Scale (HAM-D) score ≥20. Patients were randomized to citalopram (Celexa) 20-40 mg/day vs. placebo and to interpersonal psychotherapy plus clinical management vs. clinical management alone for 12 weeks (JAMA. 2007;297:367-379). Citalopram dose was 10 mg daily for one week, then 20 mg daily, and then increased to 40 mg daily after six weeks if HAM-D score was >8. All patients had weekly individual clinical-management sessions with the same therapists who carried out interpersonal psychotherapy sessions; therapists avoided specific psychotherapeutic actions (interpretations of behavior or feelings and exploration of interpersonal issues) in the control group. Intention-to-treat analysis included all 284 patients; 267 (94%) completed HAM-D ratings (by blinded rater) at 12 weeks. Fifty-four patients (19%) discontinued one or both treatments.

After 12 weeks, outcomes favored citalopram over placebo. Mean reduction in HAM-D score was 14.9 vs. 11.6 (P=.005), and mean reduction in Beck Depression Inventory II score was 14.7 vs. 11.1 (P=.005). Rates of remission, defined as HAM-D score ≤8, were 35.9% with citalopram vs. 22.5% with placebo (P=.01, NNT 8); rates of response (at least 50% reduction from baseline) were 52.8% with citalopram vs. 40.1% with placebo (P =.03, NNT 8). The results were statistically significant in a subgroup of 136 patients with recurrent depression, but there were no significant differences in a subgroup of 148 patients with first-ever depression. Adverse effects associated with citalopram included dizziness (48.6% vs. 30.3%, NNH 5), diarrhea (49.3% vs. 23.9%, NNH 4), somnolence (43.7% vs. 25.4%, NNH 5), sweating (39.4% vs. 23.9%, NNH 6), palpitations (25.4% vs. 14.8%, NNH 6), and decreased libido or sexual difficulties (21.1% vs. 7%, NNH 7).

Comparing interpersonal psychotherapy vs. clinical management at 12 weeks, mean reduction in HAM-D score was 12.1 vs. 14.4 (P=.06) and mean reduction in Beck Depression Inventory II score was 13.5 vs. 12.4 (P=.37). There were no significant differences in rates of remission (28.2% vs. 30.3%) or response (43% vs. 50%). The results favored clinical management, but none was statistically significant. Interpersonal psychotherapy was associated with fatigue (47.9% vs. 7%, NNH 7).