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.
RCT Entities:
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.
Authors: Kamber L Hart; Michael E Henry; Thomas H McCoy; Stephen J Seiner; James Luccarelli Journal: J Affect Disord Date: 2021-11-04 Impact factor: 4.839