lithium reduced the risk of relapse to 60 % and 39 %, respectively [5]. In the present study we aimed at investigating a potential dose-effect relationship regarding relapse prevention, by comparing daily dosages of escitalopram 10 mg, 20 mg and 30 mg, and additionally we compared these regimens with a daily dosage of 100 mg nortriptyline, which is generally considered an effective target dose in the treatment of acute depression. A dose range was chosen for escitalopram but not for nortriptyline, since escitalopram was the primary focus, whereas nortriptyline was our reference. Unfortunately, the planned sample size was not achieved, and therefore this report also addresses design issues having an impact on study feasibility, which might be of importance for future research in the field.
Methods
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OrganisationThis study was carried out within the Danish University Antidepressant Group (DUAG), [6].
Introduction
▼Clinical practice and several randomised controlled studies have shown that a considerable proportion of patients with severe depression treated with electroconvulsive treatment (ECT) achieve remission after 8-12 treatment sessions over a period of 3-4 weeks [1]. However, the risk of relapse/recurrence is high in the following months. In a recent meta-analysis, the risk of relapse was estimated to be around 40 % in a 6 month period after ECT [2]. The evidence on relapse preventing efficacy of antidepressant medication after ECT is sparse regarding choice of drugs and dosage [3]. In a randomised controlled prevention study covering a 25-week period after ECT, patients treated with paroxetine had a significantly lower risk of relapse (10 % relapse) than patients treated with imipramine (30 % relapse) and placebo (65 % relapse) [4]. In a subsequent prevention study it was shown that 84 % of subjects in remission after ECT relapsed on placebo drug treatment over a 25-week period, while treatment with nortriptyline and the combination of nortriptyline and is an effective treatment for severe depression but carries a risk of relapse in the following months. Methods: Major depressive disorder patients in a current episode attaining remission from ECT (17-item Hamilton Depression Rating Scale (HAM-D 17 ) score ≤ 9) received randomly escitalopram 10 mg, 20 mg, 30 mg or nortriptyline 100 mg as monotherapies and were followed for 6 months in a multicentre double-blind set-up. Primary endpoint was relapse (HAM-D 17 ≥ 16). Results: As inclusion rate was low the study was prematurely stopped with only 47 patients