A Phase 4 interventional study of EmSam in Bipolar Depression, sponsored by New York State Psychiatric Institute. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-10-28.
Sponsored by New York State Psychiatric Institute · Phase 4, Interventional, and Treatment
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.
8,055 studies on the registry are indexed under Depression; 1,643 are open to participants now.
This study's enrollment of 3 is below the median of 84 across 6,718 interventional studies indexed under Depression.
Browse Depression studies →New York State Psychiatric Institute is the lead sponsor of 425 studies on the registry; 26 are open to participants now.
Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: EmSam
Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch
Also known as: Selegiline Transdermal
Reduction of Depression CGI Score (<= 2)
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.
Time frame: 8 weeks
20 patients recruited from DES outpatient population with Bipolar Depression, ages 18-65.
| Milestone | EmSam |
|---|---|
| Started | 3 |
| Completed | 0 |
| Not completed | 3 |
| Withdrew: No funding | 3 |
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.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| EmSam | — | 0/3 (0%) | 0/3 (0%) |
Seeking pilot data
| Age, Categorical(Participants) | Open EmSam |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 3 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Open EmSam |
|---|---|
| Female | 1 |
| Male | 2 |
| Region of Enrollment(participants) | Open EmSam |
|---|---|
| United States | 3 |
This study is terminated, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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New York State Psychiatric Institute