A Pilot Study Assessing EmSam in Bipolar Depression

Phase 4TerminatedNCT00535262

New York State Psychiatric Institute3 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bipolar Depression

Interventions

EmSamDRUG

Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Ages 18 - 65 2. DSM-IV Bipolar Disorder (I, II, NOS), Depressed Phase 3. 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). 4. Prior failure of or inability to tolerate at least one other antidepressant treatment 5. Physically healthy 6. Agrees to participate in the study 7. HAM-D 24 \> 10 Exclusion Criteria: 1. Bipolar Disorder (I, II, NOS), Mixed State without adequate mood stabilization 2. Prior significant adverse reaction to EmSam 3. Unstable medical disorder 4. History of epilepsy (febrile seizure o.k.) 5. Current use of any medication that might interact with EnSam. 6. Use within 2 weeks of other antidepressant medication (6 weeks for fluoxetine) 7. Inability to adhere to a tyramine-free diet 8. Recent (past 6 months) suicide attempt 9. Serious suicidal ideation 10. Pregnant 11. Breast feeding 12. Fecund, sexually active females, without adequate contraception 13. Prior failure to respond to 2 or more adequate oral MAOI trials (2/3 PDR maximum dose, minimum 4 weeks) 14. Non-nicotine substance abuse/dependence within the past 6 months (1 year for amphetamines/cocaine)

Locations (1)

New York State Psychiatric Institute

New York, New York, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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