Relapse during continuation pharmacotherapy after acute response to ECT: a comparison of usual care versus protocolized treatment.

BACKGROUND: ECT, an effective treatment for major depression, is associated with a high relapse rate. Roughly half of all responders during the acute treatment phase relapse during continuation treatment. Recent literature has pointed out an "efficacy-effectiveness gap" in outcomes of patients enrolled in study protocols when compared to "care as usual." This study compares the effectiveness of usual care versus protocolized pharmacotherapy in preventing relapse following ECT. METHODS: One hundred twenty-six depressed patients responded to acute ECT. Seventy-three were randomized to continuation pharmacotherapy consisting of nortriptyline, nortriptyline-plus-lithium, or placebo. The 53 patients that refused to participate in the randomized trial were followed naturalistically for 6 months or until depression relapse in usual care settings. RESULTS: All but one "usual care" patient received pharmacotherapy following ECT; 27 (51%) relapsed within 6 months. Only one usual care patient received continuation ECT as a first-line treatment. The "usual care" relapse rate was intermediate to the relapse rates of the patients receiving protocolized nortriptyline (60%) and nortriptyline-plus-lithium (39%), but superior to placebo (84%). CONCLUSIONS: The relapse rate associated with usual care following ECT was comparable to that of protocolized pharmacotherapy. This suggests that high relapse rates following ECT are not due solely to an "efficacy-effectiveness gap."