Relapse Prevention in Major Depressive Disorder After Successful Acute Electroconvulsive Treatment: a 6-month Double-blind Comparison of Three Fixed Dosages of Escitalopram and a Fixed Dose of Nortriptyline – Lessons from a Failed Randomised Trial of the Danish University Antidepressant Group (DUAG-7)

Abstract

Introduction: Electroconvulsive treatment (ECT) 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-D₁₇) 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-D₁₇≥16).

Results: As inclusion rate was low the study was prematurely stopped with only 47 patients randomised (20% of the planned sample size). No statistically significant between-group differences could be detected. When all patients receiving escitalopram were compared with those receiving nortriptyline, a marginal superiority of nortriptyline was found (p=0.08). One third of patients relapsed during the study period, and one third completed.

Discussion: Due to small sample size, no valid efficacy inferences could be made. The outcome was poor, probably due to tapering off of non-study psychotropic drugs after randomisation; this has implications for future study designs.

ClinicalTrials.gov Identifier: NCT00660062

Key words

electroconvulsive treatment - major depressive disorder - relapse prevention - escitalopram - nortriptyline

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