NCT00535262

A Pilot Study Assessing EmSam in Bipolar Depression

A Pilot Study Assessing Efficacy, Safety, and Tolerability of EmSam in Bipolar Depression

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Bipolar Depression

Interventions

Type	Name	Description
DRUG	EmSam	Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch

Timeline

• Start date: 2007-03-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2007-09-26
• Last updated: 2014-10-28
• Results posted: 2014-10-28

Locations

1 site across 1 country: United States