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A Pilot Study Assessing Efficacy, Safety, and Tolerability of EmSam in Bipolar Depression
This pilot study will evaluate the efficacy of the monoamine oxidase inhibitor (MAOI)EmSam, a selegiline transdermal system (STS), in bipolar depression.
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
New York State Psychiatric Institute
New York, New York, United States
Start Date
March 1, 2007
Primary Completion Date
February 1, 2012
Completion Date
February 1, 2012
Last Updated
October 28, 2014
3
ACTUAL participants
EmSam
DRUG
Lead Sponsor
New York State Psychiatric Institute
NCT04480918
NCT06524505
Data Source & Attribution
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