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Lack of efficacy of moclobemide or imipramine in the treatment of recurrent brief depression: results from an exploratory randomized, double-blind, placebo-controlled treatment study

Baldwin, David S.a,d; Green, Maryb; Montgomery, Stuart A.c

International Clinical Psychopharmacology:
doi: 10.1097/YIC.0000000000000042
Original Articles
Abstract

‘Recurrent brief depression’ (RBD) is a common, distressing and impairing depressive disorder for which there is no current proven pharmacological or psychological treatment. This multicentre, randomized, fixed-dose, parallel-group, placebo-controlled study of the reversible inhibitor of monoamine oxidase moclobemide (450 mg/day) and the tricyclic antidepressant imipramine (150 mg/day) evaluated the potential efficacy of active medication, when compared with placebo, in patients with recurrent brief depression, recruited in the mid-1990s. After a 2–4-week single-blind placebo run-in period, a total of 35 patients were randomized to receive double-blind medication for 4 months, but only 16 completed the active treatment period. An intention-to-treat analysis of the 34 evaluable patients found no evidence for the efficacy of moclobemide or imipramine, when compared with placebo, in significantly reducing the severity, duration or frequency of depressive episodes. A total of 28 patients experienced at least one adverse event, and four patients engaged in nonfatal self-harm. Limitations of the study include the small sample size and the high rate of participant withdrawal. The lack of efficacy of these antidepressant drugs and the previous finding of the lack of efficacy of the selective serotonin reuptake inhibitor fluoxetine together indicate that medications other than antidepressant drugs should be investigated as potential treatments for what remains a common, distressing and potentially hazardous condition.

Author Information

aClinical and Experimental Sciences Academic Unit, Faculty of Medicine, University of Southampton, Southampton

bDepartment of Psychiatry, Northwick Park Hospital, Middlesex

cImperial College School of Medicine, London, UK

dDepartment of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa

Correspondence to David S. Baldwin, University Department of Psychiatry, College Keep, 4-12 Terminus Terrace, Southampton SO14 3DT, UK Tel: +44 2380 718 520; fax: +44 2380 718 532; e-mail: dsb1@soton.ac.uk

Received January 15, 2014

Accepted April 7, 2014

© 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins