Transdermal selegiline in major depression: a double-blind, placebo-controlled, parallel-group study in outpatients.
OBJECTIVE
The authors investigated the efficacy and safety of transdermal selegiline in adult outpatients with major depressive disorder.


METHODS
Following a 1-week placebo lead-in, 177 adult outpatients with major depressive disorder were randomly assigned to receive transdermal selegiline (20 mg applied once daily by means of a 20-cm(2) patch) (N=89) or placebo (N=88) for 6 weeks. The patients followed a tyramine-restricted diet during the medication trial and for 2 weeks after completion of treatment. Response to medication or placebo was measured by using the 17-item and 28-item versions of the Hamilton Depression Rating Scale, the Montgomery-Asberg Depression Rating Scale, and the Clinical Global Impression (CGI) severity and improvement measures.


RESULTS
Greater improvement was observed after 6 weeks in patients treated with transdermal selegiline than in those given placebo according to all measures. A statistically significant difference between drug and placebo was seen in Hamilton depression scale and Montgomery-Asberg Depression Rating Scale scores as early as week 1 of treatment. There were no differences in the adverse event profile of the patients given selegiline and those given placebo with the exception of application-site reactions, which were more common with the selegiline transdermal system. No orthostatic hypotensive or hypertensive reactions were observed.


CONCLUSIONS
Transdermal selegiline (20 mg applied once daily by means of a 20-cm(2) patch) administered for 6 weeks was an effective and well-tolerated treatment for adult outpatients with major depression. The typical side effects commonly seen with traditional monoamine oxidase inhibitor antidepressants were not observed.
Bodkin
J Alexander
JA
McLean Hospital, 115 Mill St. Belmont, MA 02478, USA. abodkin@mclean.harvard,edu
Amsterdam
Jay D
JD
D000279:Administration, Cutaneous; D000328:Adult; D000928:Antidepressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008996:Monoamine Oxidase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D010555:Personality Inventory; D012642:Selegiline / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D000928:Antidepressive Agents; D008996:Monoamine Oxidase Inhibitors; D012642:Selegiline