Selegiline Transdermal System in the Prevention of Relapse of Major Depressive Disorder: A 52-Week, Double-blind, Placebo-Substitution, Parallel-Group Clinical Trial
Amsterdam JD, Bodkin JA.
*Depression Research Unit, Department of Psychiatry,
University of Pennsylvania,
School of Medicine, Philadelphia, PA;
McLean Hospital, Belmont, MA
Consolidated Department of Psychiatry,
Harvard Medical School, Boston, MA.
J Clin Psychopharmacol. 2006 Dec;26(6):579-586.


The selegiline transdermal system (STS) is a monoamine oxidase inhibitor (MAOI) with unique pharmacokinetic and pharmacodynamic properties that was developed to overcome limitations of orally administered MAOIs, particularly dietary tyramine restrictions. We present data from a long-term study assessing the safety and efficacy of initial and continuation STS therapy in patients with major depressive disorder (MDD). After 10 weeks of treatment with STS 6 mg/24 h, 322 patients who responded with a 17-item Hamilton Depression Rating Scale score of 10 or less were randomly assigned to double-blind treatment with STS 6 mg/24 h or placebo for 52 weeks. Relapse was defined as meeting the following criteria on 2 consecutive visits: (1) 17-item Hamilton Depression Rating Scale score of 14 or more, (2) a Clinical Global Impression of Severity score of 3 or more with a 2-point increase from double-blind baseline, and (3) the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for a major depressive episode. At study week 52, significantly fewer STS patients experienced relapse of major depressive episode (25/149 [16.8%]) compared with placebo (50/163 [30.7%]) (P = 0.0025). In addition, patients receiving STS experienced a significantly longer time to relapse compared with those receiving placebo (P = 0.0048). The safety profile of STS was similar to placebo, with the exception of application-site reactions (STS, 15.2%; placebo, 3.7%). No cases of hypertensive crisis were reported, despite the lack of requirement for dietary tyramine restrictions. In conclusion, STS was well tolerated and efficacious in maintaining a sustained response in MDD patients. The results of this study suggest that STS may be suitable in the long-term treatment of MDD.
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