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Background: The use of double-blind designs, normally the criterion standard of clinical trials, is impossible when comparing medication therapy to procedural therapies for depression. In the Consortium for Research in Electroconvulsive Therapy (CORE) trial, depressed patients recently remitted with electroconvulsive therapy (ECT) were randomly assigned to receive continuation therapy with either ECT or medications. The purpose of this article is to describe the design characteristics and challenges of the trial and of our method of dealing with the lack of double-blind outcome assessment., Methods: The primary outcome measure was time to relapse of depression in the continuation phase. We developed a method to achieve partial blinding of depressive severity assessment. This consisted of videotaping the structured interviews, having the video tapes co-rated by personnel not involved in the patient's care, and a videotape-tracking maneuver so that the assessor of the videotapes could be blinded to phase and type of treatment., Results: We enrolled 624 patients into the initial treatment phase of the trial. Of these, 201 met criteria for randomization into the second, continuation phase. Our videotape-tracking maneuver to reduce bias in outcome assessment worked well during the trial., Conclusions: The CORE study is the first multicenter, randomized controlled trial of continuation ECT in the relapse prevention of major depressive episodes. We successfully recruited a large number of severely depressed patients into a 6 month trial and used a method of reducing bias that might result from lack of blinding.

Objective: To determine the relationship between baseline melancholic features with outcomes in patients with major depressive disorder referred for electroconvulsive therapy (ECT)., Method: In a multihospital (Consortium for Research in ECT) collaborative ECT study, SCID-1 interviews were obtained at study entry. Ratings of the 24-item Hamilton Rating Scale for Depression were obtained thrice weekly during the course of ECT, once during a subsequent treatment-free week, and periodically during 6-month continuation treatment with either bitemporal ECT or nortriptyline plus lithium (continuation pharmacotherapy)., Results: The evaluable sample was severely ill with a mean 24-item Hamilton Rating Scale for Depression score of 35.2 (+/-6.9). Of 489 patients, 63.6% (311) met DSM-IV criteria for melancholic features. During acute ECT, 62.1% of those with melancholic features remitted, as compared with 78.7% for those without melancholic features (P = 0.002). During medication continuation treatment (continuation pharmacotherapy), relapse rates were higher for those with melancholic features than for those without these features. Conversely, with continuation ECT, the rate of relapse was lower for those with, compared with those without, melancholic features., Conclusions: Ascertaining melancholic features by SCID-1 criteria does not identify depressed patients more likely to respond to ECT as had been anticipated from the literature. Melancholic features were associated with poorer treatment outcomes in acute ECT. Those with melancholic features were less likely to relapse with continuation ECT, but those with melancholic features were more likely to relapse with continuation pharmacotherapy. The limitations of the DSM-IV criteria for melancholia are discussed.