A Pilot Study Assessing EmSam in Bipolar Depression

Status Terminated

Clinical Trial Summary

This pilot study will evaluate the efficacy of the monoamine oxidase inhibitor (MAOI)EmSam, a selegiline transdermal system (STS), in bipolar depression.

Clinical Trial Description

Most current treatments for bipolar depression have been shown to be of modest effectiveness. There is some literature which suggests that Monoamine Oxidase Inhibitors (MAOIs) have greater efficacy than tricyclic antidepressants, and that they are effective for treatment-resistant depression of all types, both unipolar and bipolar. The MAOI selegiline has demonstrated antidepressant efficacy. EmSam, a selegiline transdermal system, provides central nervous system but not intestinal/liver MAO inhibition without clinically significant increases in sensitivity to dietary tyramine. This transdermal system appears to be associated with fewer side effects and increased safety relative to oral MAOI's. This pilot study will evaluate the efficacy of EmSam in bipolar depression. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00535262
Study type	Interventional
Source	New York State Psychiatric Institute
Contact
Status	Terminated
Phase	Phase 4
Start date	March 2007
Completion date	February 2012

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