The selegiline transdermal system in major depressive disorder: A systematic review of safety and tolerability
by
Robinson DS, Amsterdam JD.
Worldwide Drug Development, 102 East Avenue,
Burlington, VT 05401, United States.
J Affect Disord. 2007 Jun 11;

ABSTRACT

BACKGROUND: Monoamine oxidase inhibitors (MAOIs) are highly efficacious antidepressants, but safety concerns have limited their broad use. METHODS: We reviewed key safety and tolerability data from all clinical trials of patients with major depressive disorder (MDD) accrued during the clinical development of the selegiline transdermal system (STS), as reported to the Food and Drug Administration. This review includes data from both controlled and uncontrolled clinical trials involving STS-treated (n=2036) and placebo-treated (n=668) patients. RESULTS: Except for the initial trial, subsequent trials, which involved STS doses ranging from 3 mg/24 h to 12 mg/24 h, lacked tyramine restrictions, and no acute hypertensive reactions occurred during study treatment. Safety experience with STS 6 mg/24 h supports this therapeutic dose without tyramine dietary modifications, but until more data are available for STS doses 9 mg/24 h and 12 mg/24 h, foods that are rich sources of tyramine should be avoided. The principal side effects of STS therapy were local dermal reactions and insomnia, both of which were dose-related. Side effects associated with MAOI treatment, such as sexual dysfunction and excessive weight gain, were uncommon. CONCLUSIONS: A comprehensive review of safety from the clinical development program suggests that the STS is safe and well tolerated, with an improved safety margin compared with orally administered MAOIs.

Metabolism
High-dosage
Sexual effects
Antidepressant
Phenylethylamine
Antioxidant dosage
Atypical depressives
Long-term high-dosage
Selegiline plus phenylalanine
Selegiline and life-expectancy
Selegiline for longer-lived flies
EMSAM/antidepressant efficacy
Selegiline as an immunostimulant
Selegiline for cocaine-dependence
Selegiline and Parkinson's disease
Selegiline, NO and Alzheimer's disease
Antidepressant/dopamine D1 receptors
Transdermal selegiline as an antidepressant
Somerset's new transdermal selegiline patch

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