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Psych Congress  

Efficacy and Safety of Selegiline Transdermal System for Atypical Depression: Pooled Analysis of Short-Term, Placebo-Controlled Trials

Authors  
Saeheon Jang, MD; Ashwin Patkar, MD, MRC Psych; Kimberly Portland, PhD; Terry Painter, BS; Sungwon Jung, MD, PhD; Chi-Un Pae, MD, PhD; Craig Nelson, MD
Sponsor  
Mylan Specialty L.P.

Study Objective: Monoamine oxidase inhibitors (MAOIs) have been reported to be of particular benefit in major depressive disorder (MDD) with atypical features. Selegiline transdermal system (STS) is an MAOI that bypasses the gastrointestinal system and reduces the risk for dietary interactions; particularly at the lowest dose. We investigated the efficacy and safety of STS in MDD with atypical features. Method: We conducted a post-hoc, pooled data analysis of four short-term, randomized, double-blind, placebo-controlled trials with STS (three 8-week studies: two fixed-dose trials with 3 or 6 mg/24 hr and one flexible dose trial with 6, 9 and 12 mg/24 hr, and one 6-week trial: fixed dose 6 mg/24 hr). In accordance with published literature, atypical subtype was defined as presence of at least one item with a score of 2 or greater from items 22–26 on the 28-item Hamilton Depression Rating Scale (HAMD-28), and a maximum score of one point for items 6 (insomnia late), 12 (somatic symptoms, gastrointestinal), and 16 (loss of weight) to exclude vegetative features of melancholic depression. Response was defined as ≥50% reduction in HAMD-28 scores and remission as ≤10 HAMD-28 score at the end of the trials. We used repeated measures ANCOVA and Chi-square tests to compare between-group differences on the primary outcome measure of mean change in total HAMD-28 score from beginning to end of treatment. Descriptive statistics were used to examine rates of adverse events in the two groups. Results: STS (n=667) significantly decreased HAMD-28 total score compared with placebo (n=516) from beginning to end of treatment (-11.2±9.6 vs -9.9±9.6, F=5.846, p=0.016). Two hundred and eighty six (24.2%) subjects met the definition of atypical subtype. STS showed comparable efficacy between the atypical (n=158) and non-atypical (n=509) subtypes with respect to total HAMD-28 score change (12.2±9.6 vs 10.9±9.6, F=0.135, p=0.714), response rates (40.3% vs 41.9%, p=0.729) and remission rates (27.3% vs 28.4%, p=0.809) respectively. Discontinuation rates were similar in the atypical (12.7%) and non-atypical (9.2%) subtypes (p=0.211). The atypical and non-atypical groups were comparable in rates of skin reactions (25.9% vs 28.5%), insomnia (7.6% vs 10.6%) and headache (6.3% vs 5.7%). We reanalyzed the data excluding subjects given the 3 mg/24 hr dose (n=150, 10.8%), because this dose was determined not to be effective for MDD and thus was not submitted to the FDA. The findings remained similar to the original pooled analysis. Conclusions: In this pooled analysis, STS appears to be efficacious for patients with atypical depression, a historically difficult-to-treat subtype of MDD. STS was equally efficacious in atypical and non-atypical subtypes of MDD. These findings are consistent with results of a post-hoc analysis of the open-label phase of a relapse prevention trial of STS. Prospective trials are necessary to confirm these findings. Educational Objective: After studying this material, participants should be better able to understand the efficacy of a transdermal MAOI in patients with atypical depression. Funding: This study was supported by funding from Mylan Specialty L.P.

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