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Psych Congress  

Selegiline Transdermal System (STS) in Patients with Recurrent, Unipolar Major Depression: A Post-hoc Analysis of Two Randomized, Double-blind Studies

Authors  
Kimberly Portland, PhD; Donald Robinson, MD
Sponsor  
Mylan Specialty L.P.

Study Objective: Major depressive disorder (MDD) is a debilitating, chronic condition that can recur in >75% of patients and last 2 years or longer in 15% to 20% of patients. Selegiline transdermal system (STS) is a well-tolerated acute and maintenance treatment for MDD. STS delivers sustained blood levels of monoamine oxidase inhibitor (MAOI) directly into the systemic circulation, avoiding the need for a tyramine-restricted diet at the 6 mg/day dose. The objective of this post-hoc analysis was to examine the efficacy of STS vs placebo in recurrent, unipolar major depression. Method: Data from two pivotal (one 6 week and one 8 week), randomized, double-blind, placebo-controlled clinical trials of STS were pooled for this analysis (N=433). Single vs recurrent depressive episodes were coded by the investigator at the baseline assessment. An analysis of covariance (ANCOVA) model, controlling for baseline severity and study, was used to evaluate the effect of treatment as measured by the 28-item Hamilton Rating Scales for Depression (HAMD-28) and the Montgomery-Åsberg Depression Rating Scale (MADRS) at study endpoint. Chi-square analysis was used to assess differences between STS and placebo in rates of remission. Results: Nearly three quarters of the patients (70.4%; n=305) had “recurrent depression” (mean [SD] baseline HAMD-17 score was 23.1 [±2.4]). In patients with recurrent depressive episodes, STS showed significantly greater improvement at endpoint on MADRS and HAMD-28 total scores vs patients receiving placebo (p<0.001). Additionally, remission rates as defined by endpoint HAMD-28 and MADRS scores were significantly greater in patients with recurrent depression treated with STS than placebo. HAMD-28 remission rates were 21.8% vs 10.1% (STS vs placebo; p<0.01) and MADRS remission rates were 27.9% vs 13.3% (STS vs placebo; p<0.01). Conclusion: STS is an effective treatment for patients with recurrent episodes of unipolar, major depression. Interestingly, treatment effects were not as strong in patients with single episode depression. Educational Objective: After studying this material, participants should be better able to understand the efficacy of a transdermal MAOI for patients with recurrent, unipolar major depression. Funding: This study was supported by funding from Mylan Specialty L.P.

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