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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

Published online by Cambridge University Press:  29 October 2013

Chi-Un Pae ,
Ashwin A. Patkar ,
Saeheon Jang ,
Kimberly B. Portland ,
Sungwon Jung  and
J. Craig Nelson
Chi-Un Pae
Affiliation:
Department of Psychiatry, Duke University Medical Center, Durham, North Carolina, USA Department of Psychiatry, The Catholic University of Korea College of Medicine, Seoul, Korea
Ashwin A. Patkar*
Affiliation:
Department of Psychiatry, Duke University Medical Center, Durham, North Carolina, USA
Saeheon Jang
Affiliation:
Department of Psychiatry, Duke University Medical Center, Durham, North Carolina, USA
Kimberly B. Portland
Affiliation:
Mylan Specialty L.P., Basking Ridge, New Jersey, USA
Sungwon Jung
Affiliation:
Department of Psychiatry, Duke University Medical Center, Durham, North Carolina, USA
J. Craig Nelson
Affiliation:
Department of Psychiatry, University of California–San Francisco, San Francisco, California, USA
*
*Addresses for correspondence: Ashwin A. Patkar, MD, Department of Psychiatry, Duke University Medical Center, 2218 Elder Street, Durham, NC 27705, USA. (Email Ashwin.patkar@duke.edu)
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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.

Keywords

Atypical depressionefficacyremissionresponseselegiline transdermal systemtolerability
Type
Original Research
Information
CNS Spectrums , Volume 19 , Issue 4 , August 2014 , pp. 324 - 329
Copyright
Copyright © Cambridge University Press 2013 

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Footnotes

This study has been supported by funding from Mylan Specialty L.P. (formerly Dey Pharma, L.P.).

Some parts of this paper have been presented as a poster at the 25th Congress of the European College of Neuropsychopharmacology, Vienna, Austria, October 13–17, 2012.

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