A Pilot Study Assessing 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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study Assessing Efficacy, Safety, and Tolerability of EmSam in Bipolar Depression|
- Reduction of Depression CGI Score (<= 2) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
HAM-D score. Young Mania Scale Life Chart Method Patient Global Impression Symptom Checklist - 90 Quality of Life Enjoyment and Satisfaction Questionnaire
0 participants analyzed due to early termination of study.
|Study Start Date:||March 2007|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
EmSam will be administered in open-label fashion for 8-weeks during phase I of the study during which symptoms of depression will be assessed weekly. Those whose depression responds after 8-weeks will be entered into an 8-month open-label continuation phase during which they will be maintained on EmSam and be assessed on a monthly basis.
Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch
Other Name: Selegiline Transdermal
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00535262
|United States, New York|
|New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||Deborah Deliyannides, M.D.||New York State Psychiatric Institute|