Selegiline Transdermal System for the Treatment of Major Depressive Disorder: An 8-Week, Double-Blind, Placebo-Controlled, Flexible-Dose Titration Trial
J Clin Psychiatry 2006;67(9):1354-1361
© Copyright 2014 Physicians Postgraduate Press, Inc.
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Objective: This study investigated the
efficacy, safety, and tolerability of the
selegiline transdermal system (STS) administered in a
dose range of 6 mg/24 hours to 12 mg/24 hours for treating major depressive disorder (MDD).
Method: Patients meeting DSM-IV criteria
for MDD (N = 265) were randomly assigned to blinded treatment with STS or a matching
placebo patch for 8 weeks. Patients failing to meet
or maintain protocol-defined therapeutic response criteria at predetermined time points had
their STS (or placebo) dose increased. Assessments were conducted at weeks 1, 2, 3, 5, 6, and 8.
Patients were not required to follow a tyramine-restricted diet. The study ran from
September 2001 through August 2002.
Results: Selegiline transdermal system
treatment resulted in significantly greater
improvement (p <= .05) compared with placebo
treatment on the 3 depression rating scales: the
28-item Hamilton Rating Scale for Depression
(HAM-D28) (primary outcome measure), the
Montgomery-Asberg Depression Rating Scale, and the
Inventory for Depressive Symptomatology-Self Rated. The treatment effect measured by
the HAM-D28 was modest, primarily due to
insomnia side effects. The antidepressant efficacy of
STS was substantiated further by the significantly greater improvement in core depression
symptoms (HAM-D Bech-6 subscale). The side effects of highest incidence were application-site
reactions and insomnia. There were no safety concerns based on routine clinical laboratory
and electrocardiogram monitoring, and there were
no occurrences of hypertensive crisis.
Conclusion: Results of this double-blind,
placebo-controlled, dose titration trial provide
evidence of short-term efficacy, safety, and
tolerability of STS in the dose range of 6 mg/24 hours
to 12 mg/24 hours for treatment of MDD. Selegiline transdermal system has an improved margin
of safety compared with oral monoamine oxidase inhibitors and represents a useful addition to
the existing array of antidepressants.