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Selegiline Transdermal System Shows Modest But Significant Antidepressant Effect
A DGReview of :"A double-blind, placebo-controlled trial of the safety and efficacy of selegiline transdermal system without dietary restrictions in patients with major depressive disorder"
Journal of Clinical Psychiatry
03/19/2003
By Elda Hauschildt
Use of a selegiline transdermal system offers modest but statistically significant antidepressant benefit in outpatients with major depressive disorder, a study in the United States indicates.
Antidepressant efficacy superior to placebo had already been demonstrated with selegiline, a monoamine oxidase (MAO) inhibitor, explain investigators from the University of Pennsylvania School of Medicine in Philadelphia. The transdermal system tested provided targeted MAO inhibition without clinically significant increases in sensitivity to dietary tyramine.
The researchers say the system has pharmacokinetic and pharmacodynamic properties that allow inhibition of central nervous system MAO-A and MAO-B enzymes while substantially avoiding inhibition of liver and intestinal MAO-A enzymes.
There were 365 outpatients enrolled in the double-blind, placebo-controlled, multi-site trial, with 289 randomised to therapy with either a selegiline (145) or a placebo (144) patch system for up to eight weeks. Participants ranged in age from 18 to 65 years.
"Although the effect size was modest, at endpoint the selegiline transdermal system was statistically superior to placebo on the Montgomery and Asberg Depression Rating Scale (MADRS) and Hamilton Rating Scale for Depression (HAM-D)-28 ratings and showed a non-significant superiority on the HAM-D-17 and Clinical Global Impressions-Severity ratings," the investigators report.
Only application-site reaction varied between selegiline and placebo, with 31.5% of selegiline patients having reactions. This compared to 15.1% of placebo recipients.
Journal of Clinical Psychiatry, 2003;64:208-214.
"A double-blind, placebo-controlled trial of the safety and efficacy of selegiline transdermal system without dietary restrictions in patients with major depressive disorder"
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