Journal of Affective Disorders
Volume 105, Issue 1 , Pages 15-23 , January 2008

The selegiline transdermal system in major depressive disorder: A systematic review of safety and tolerability

  • Donald S. Robinson

      Affiliations

    • Worldwide Drug Development, 102 East Avenue, Burlington, VT 05401, United States
    • Corresponding Author InformationCorresponding author. Tel.: +1 802 658 2961.
    • ,
  • Jay D. Amsterdam

      Affiliations

    • Depression Research Unit, Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, PA, United States

Received 19 December 2006 ,Revised 4 April 2007 ,Accepted 24 April 2007.

References 

  1. Amsterdam JD, Chopra M. Monoamine oxidase inhibitors revisited. Psychiatr. Ann. 2001;31:361–370
  2. Amsterdam JD. A double-blind, placebo-controlled trial of the safety and efficacy of selegiline transdermal system without dietary restrictions in patients with major depressive disorder. J. Clin. Psychiatry. 2003;64:208–214
  3. Amsterdam JD, Bodkin JA. Selegiline transdermal system in the prevention of relapse of major depressive disorder: a 52-week, double-blind, placebo-substitution, parallel-group clinical trial. J. Clin. Psychopharmacol. 2006;26:579–586
  4. Azzaro AJ, VanDenBerg CM, Blob LF, Kemper EM, Sharoky M, Oren DA, et al. Tyramine pressor sensitivity during treatment with the selegiline transdermal system 6 mg/24 hr in healthy subjects. J. Clin. Pharmacol. 2006;46:933–944
  5. Azzaro AJ, Ziemniak J, Kemper E, Campbell BJ, VanDenBerg C. Selegiline transdermal system: an examination of the potential for CYP450-dependent pharmacokinetic interactions with 3 psychotropic medications. J. Clin. Pharmacol. 2007;47(2):146–158
  6. Blackwell B. Hypertensive crisis due to monoamine-oxidase inhibitors. Lancet. 1963;38:849–851
  7. Bodkin JA, Amsterdam JD. Transdermal selegiline in major depression: a double-blind, placebo-controlled, parallel group study in outpatients. Am. J. Psychiatry. 2002;159:1869–1875
  8. DaPrada M, Zurcher G, Wuthrich I, Haefely WE. On tyramine, food, beverages, and the reversible MAO inhibitor moclobemide. J. Neural Transm. 1988;26(suppl):31–56
  9. EMSAM® [package insert], 2006. New York, NY: Bristol-Myers Squibb.
  10. Feiger AD, Rickels K, Rynn MA, Zimbroff DL, Robinson DS. Selegiline transdermal system for the treatment of major depressive disorder: an 8-week, double-blind, placebo-controlled, flexible-dose titration trial. J. Clin. Psychiatry. 2006;67:1354–1361
  11. Greden JF. Unmet need: what justifies the search for a new antidepressant?. J. Clin. Psychiatry. 2002;63:3–7
  12. Kennedy SH, Eisfeld BS, Dickens SE, Bacchiochi JR, Bagby RM. Antidepressant-induced sexual dysfunction during treatment with moclobemide, paroxetine, sertraline, and venlafaxine. J. Clin. Psychiatry. 2000;61:276–281
  13. Mann JJ, Aarons SF, Wilner PJ, Keilp JG, Sweeney JA, Pearlstein T, et al. A controlled study of the antidepressant efficacy and side effects of (−)deprenyl: a selective monoamine oxidase inhibitor. Arch. Gen. Psychiatry. 1989;46:45–50
  14. Mawhinney M, Cole D, Azzaro AJ. Daily transdermal administration of selegiline to guinea-pigs preferentially inhibits monoamine oxidase activity in brain when compared with intestinal and hepatic tissues. J. Pharm. Pharmacol. 2003;55:27–34
  15. McGrath PJ, Stewart JW, Harrison W, Wager S, Nunes EN, Quitkin FM. A placebo-controlled trial of l-deprenyl in atypical depression. Psychopharmacol. Bull. 1989;25:63–67
  16. Pauporte M, Azzaro AJ, Moonsammy G, Maibach H. Selegiline transdermal system (STS): assessments of dermal safety in human. J. Toxicol. Cutaneous Ocul. Toxicol. 2004;23:179–187
  17. Pauporte M, Goodhead M, Azzaro AJ, Moonsammy G, Maibach H. Selegiline transdermal system (STS): preclinical assays of dermal safety. J. Toxicol. Cutaneous Ocul. Toxicol. 2004;23:173–178
  18. Prasad A, Glover V, Goodwin BL, Sandler M, Signy M, Smith SE. Enhanced pressor sensitivity to oral tyramine challenge following high dose selegiline treatment. Psychopharmacology. 1988;95:540–543
  19. Robinson DS. Monoamine oxidase inhibitors: a new generation. Psychopharmacol. Bull. 2002;36:124–138
  20. Rudorfer MV. Monoamine oxidase inhibitors: reversible and irreversible. Psychopharmacol. Bull. 1992;28:45–57
  21. Shulman KI, Walker SE, MacKenzie S, Knowles . Dietary restriction, tyramine, and the use of monoamine oxidase inhibitors. J. Clin. Psychopharmacol. 1989;9:397–402
  22. Sunderland T, Cohen RM, Molchan S, Lawlor BA, Mellow AM, Newhouse PA, et al. High-dose selegiline in treatment-resistant older depressive patients. Arch. Gen. Psychiatry. 1994;51:607–615
  23. Wecker L, James S, Copeland N, Pacheco MA. Transdermal selegiline: targeted effects on monoamine oxidases in the brain. Biol. Psychiatry. 2003;54:1099–1104

☆ Role of funding source: Data in this report were derived from research studies sponsored and funded by Somerset Pharmaceuticals, Inc. (Tampa, FL). Preparation of the report was partially funded by Bristol-Myers Squibb (Princeton, NJ) and The Jack Warsaw Endowment for Research in Biological Psychiatry of the University of Pennsylvania Medical Center (Dr. Amsterdam). Conflict of interest: Dr. Robinson has served as consultant to Bristol-Myers Squibb, Somerset Pharmaceuticals, Epix, Genaissance, Medicinova, and Ono Pharmaceuticals. Dr. Amsterdam has served as scientific consultant to Bristol-Myers Squibb and Somerset Pharmaceuticals. Contributors: Dr. Robinson analyzed and reviewed safety data in the selegiline transdermal system NDA submitted to the Food and Drug Administration by Somerset Pharmaceuticals, Inc. Dr. Robinson wrote the first draft of the manuscript. Both authors were involved with literature review, preparation, and final approval of the report.

PII: S0165-0327(07)00148-6

doi: 10.1016/j.jad.2007.04.024

Journal of Affective Disorders
Volume 105, Issue 1 , Pages 15-23 , January 2008

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