Efficacy and safety of selegiline transdermal system (STS) for the atypical subtype of major depressive disorder: pooled analysis of 5 short-term, placebo-controlled trials

Abstract

OBJECTIVE: The objective of the present study is to investigate the efficacy and safety of the selegiline transdermal system (STS) in major depressive disorder (MDD) with atypical features. METHODS: This was a post-hoc analysis of 5 short-term trials. The atypical subtype was defined as the presence of at least 1 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 1 point for items 6 (insomnia late), 12 (somatic symptoms, gastrointestinal), and 16 (loss of weight) to exclude vegetative features of melancholic depression. The mean changes of HAMD-28 total score from baseline to the endpoint (response rate defined as ≥50% reduction in HAMD-28 scores and remission rate defined as ≤10 HAMD-28 total score at the treatment endpoint) were compared between atypical and nonatypical groups. RESULTS: In this analysis, 352 subjects (STS = 168 vs placebo = 184) met the definition of atypical subtype at baseline. STS (n = 641) significantly decreased HAMD-28 total score compared with placebo (n = 648) from beginning to end of treatment (-10.7 ± 9.3 vs -9.4 ± 9.3; p = 0.014). STS showed comparable efficacy in patients with the atypical subtype compared with the nonatypical subtype for placebo-subtracted mean change in HAMD-28 total score (-2.11 ± 1.01 vs. -1.0 ± 0.60; p = 0.34), odds ratio (OR) for response (1.41 vs 1.23, p = 0.62), and OR for remission (1.77 vs 1.18, p = 0.22). CONCLUSION: STS appears to be comparably efficacious and tolerable in atypical and nonatypical subtypes of MDD. Adequately powered, controlled, clinical trials are necessary to confirm our findings.