A Pilot Study Assessing EmSam in Bipolar Depression

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

Detailed Description
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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.

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

Conditions
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Bipolar Depression

Intervention / Treatment
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* Drug: EmSam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18 - 65 DSM-IV Bipolar Disorder (I, II, NOS), Depressed Phase DSM-IV Bipolar Disorder (I,II, NOS), Mixed state with adequate mood stabilization (ie, resolution of manic or hypomanic symptoms for 8 weeks with a minimum of 4 weeks on a stable dose of mood-stabilizing medication that will be continued through all phases of the study). Prior failure of or inability to tolerate at least one other antidepressant treatment Physically healthy Agrees to participate in the study HAM-D 24 > 10 Exclusion Criteria: Bipolar Disorder (I, II, NOS), Mixed State without adequate mood stabilization Prior significant adverse reaction to EmSam Unstable medical disorder History of epilepsy (febrile seizure o.k.) Current use of any medication that might interact with EnSam. Use within 2 weeks of other antidepressant medication (6 weeks for fluoxetine) Inability to adhere to a tyramine-free diet Recent (past 6 months) suicide attempt Serious suicidal ideation Pregnant Breast feeding Fecund, sexually active females, without adequate contraception Prior failure to respond to 2 or more adequate oral MAOI trials (2/3 PDR maximum dose, minimum 4 weeks) Non-nicotine substance abuse/dependence within the past 6 months (1 year for amphetamines/cocaine)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EmSam<br>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<br>* Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch<br>* Other names: Selegiline Transdermal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bipolar, depression