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A Multisite Study From the Consortium for Research in Electroconvulsive Therapy (CORE)

Charles H. Kellner, MD; Rebecca G. Knapp, PhD; Georgios Petrides, MD; Teresa A. Rummans, MD; Mustafa M. Husain, MD; Keith Rasmussen, MD; Martina Mueller, PhD; Hilary J. Bernstein, DHA; Kevin O’Connor, MD; Glenn Smith, PhD; Melanie Biggs, PhD; Samuel H. Bailine, MD; Chitra Malur, MD; Eunsil Yim, MS; Shawn McClintock, MS; Shirlene Sampson, MD; Max Fink, MD

Arch Gen Psychiatry. 2006;63:1337-1344.

Background  Although electroconvulsive therapy (ECT) has been shown to be extremely effective for the acute treatment of major depression, it has never been systematically assessed as a strategy for relapse prevention.

Objective  To evaluate the comparative efficacy of continuation ECT (C-ECT) and the combination of lithium carbonate plus nortriptyline hydrochloride (C-Pharm) in the prevention of depressive relapse.

Design  Multisite, randomized, parallel design, 6-month trial performed from 1997 to 2004.

Setting  Five academic medical centers and their outpatient psychiatry clinics.

Patients  Two hundred one patients with Structured Clinical Interview for DSM-IV–diagnosed unipolar depression who had remitted with a course of bilateral ECT.

Interventions  Random assignment to 2 treatment groups receiving either C-ECT (10 treatments) or C-Pharm for 6 months.

Main Outcome Measure  Relapse of depression, compared between the C-ECT and C-Pharm groups.

Results  In the C-ECT group, 37.1% experienced disease relapse, 46.1% continued to have disease remission at the study end, and 16.8% dropped out of the study. In the C-Pharm group, 31.6% experienced disease relapse, 46.3% continued to have disease remission, and 22.1% dropped out of the study. Both Kaplan-Meier and Cox proportional hazards regression analyses indicated no statistically significant differences in overall survival curves and time to relapse for the groups. Mean ± SD time to relapse for the C-ECT group was 9.1 ± 7.0 weeks compared with 6.7 ± 4.6 weeks for the C-Pharm group (P = .13). Both groups had relapse proportions significantly lower than a historical placebo control from a similarly designed study.

Conclusions  Both C-ECT and C-Pharm were shown to be superior to a historical placebo control, but both had limited efficacy, with more than half of patients either experiencing disease relapse or dropping out of the study. Even more effective strategies for relapse prevention in mood disorders are urgently needed.

Author Affiliations: Department of Psychiatry, University of Medicine and Dentistry of New Jersey–New Jersey Medical School, Newark (Drs Kellner, Petrides, and O’Connor); Departments of Psychiatry and Behavioral Sciences (Dr Kellner) and Biostatistics, Bioinformatics, and Epidemiology (Drs Knapp and Mueller and Mss Bernstein and Yim), Medical University of South Carolina, Charleston; Department of Psychiatry, The Zucker Hillside Hospital, North Shore–Long Island Health System, Glen Oaks, NY (Drs Petrides, Bailine, Malur, and Fink); Department of Psychiatry and Psychology, Mayo Foundation, Rochester, Minn (Drs Rummans, Rasmussen, Smith, and Sampson); and Department of Psychiatry, University of Texas Southwestern Medical Center at Dallas (Drs Husain and Biggs and Mr McClintock).

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