Key result
Early sertraline reduces post-ECT relapse by ~81% versus placebo.
Why the study?
Relapse rates after electroconvulsive therapy remain high with standard treatments, motivating evaluation of early continuation pharmacotherapy to prevent post-ECT relapse.
Does early continuation pharmacotherapy with sertraline reduce depressive relapse in patients undergoing ECT for major depressive disorder?
RCT
Double-blind
2:2:1
Does early continuation pharmacotherapy with sertraline reduce depressive relapse in patients undergoing ECT for major depressive disorder?
Absolute Event Rate: 12.5% vs 67%
p-value: p=0.04
Early initiation of sertraline during ECT may reduce the risk of depressive relapse compared to placebo.
Supports early sertraline continuation after ECT to curb relapse; extends RCT evidence for pharmacotherapy in MDD.
OBJECTIVE: Relapse rates after electroconvulsive therapy (ECT) remain high with standard treatments. We aimed to test the efficacy of an early administered continuation pharmacotherapy (c-pharm early) strategy in prevention of post-ECT relapse. METHOD: A 20-week, randomized, double-blind, placebo-controlled trial. Patients aged 18 to 65 years diagnosed with Diagnostic and Statistical Manual of Mental Disorders major depressive disorder, with or without psychotic features, with initial Montgomery-Asberg Depression Rating Scale scores higher than 22, underwent 8 bilateral ECT sessions (2 per week). Randomization to c-pharm early, c-pharm late, and placebo groups in 2:2:1, respectively, was performed at the completion of the fourth ECT session. After randomization, subjects in the c-pharm early group were given sertraline at 150 mg/d. Subjects in the c-pharm late group were first given placebo, which was substituted with sertraline at 150 mg/d at the completion of the eight ECT. Relapse was defined as a Montgomery-Asberg Depression Rating Scale score of 16 or higher. RESULTS: Seventy-three percent of the patients responded to the given treatment. The relapse rates were 12.5% in the c-pharm early group, 28% in the c-pharm late group, and 67% in the placebo group (P = 0.09). The c-pharm early strategy resulted in significantly lower relapse rates and longer well time compared with the placebo (P = 0.04). When the trend with the initiation of the c-pharm intervention was investigated in the 3 groups with equally spaced trend weights, the time of initiation was found to have a significant effect on the probability of the remaining well (P = 0.03). CONCLUSIONS: Comparative efficacy of c-pharm early and late strategies in providing improved protection against post-ECT relapse of major depressive disorder needs to be further explored.
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Yıldız et al. (2010) conducted an RCT in Major depressive disorder. Early continuation pharmacotherapy (sertraline) vs. Placebo was evaluated on Relapse (Montgomery-Asberg Depression Rating Scale score of 16 or higher) (p=0.04). Early continuation pharmacotherapy with sertraline significantly reduced post-ECT relapse rates compared to placebo (12.5% vs 67%; P=0.04).
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