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Selegiline Transdermal System for the Treatment of Major Depressive Disorder: An 8-Week, Double-Blind, Placebo-Controlled, Flexible-Dose Titration Trial.
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.