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-Åsberg 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-Åsberg 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.
From the Departments of *Psychiatry, and †Anesthesiology, Dokuz Eylül University, Izmir, Turkey.
Received for publication December 7, 2008; accepted May 27, 2009.
Reprints: Ayşegül Yildiz, MD, Seferihisar Cad. No. 6/14 Çamli Villaları Sitesi Çamli Köyü, Güzelbahçe PK. 35310 Izmir, Turkey (e-mail: email@example.com).
†Deceased, August 3, 2002.
This study was supported in part by the independent investigator award from the Pfizer Inc, New York, NY, a research project award from the Spring Symposium, Antalya, Turkey, a research grant from the Dokuz Eylül University, Izmir, Turkey, and an educational grant from the Sanofi-Aventis Group, Istanbul, Turkey, which had no influence on design, conduct, analysis or interpretation of the results. Trial registration: AYOO22. Combination of pharmacotherapy with electroconvulsive therapy in prevention of relapse in major depressive disorder: a randomized, placebo controlled, double-blind study (Trial registration number: ISRCTN-28600786). http://www.controlled-trials.com/ISRCTN28600786/
No study investigator has relevant conflicts of interest.