A Pilot Study Assessing EmSam in Bipolar Depression

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2012-02-29

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.

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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.

Conditions

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Bipolar Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EmSam

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.

Group Type EXPERIMENTAL

EmSam

Intervention Type DRUG

Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch

Interventions

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EmSam

Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch

Intervention Type DRUG

Other Intervention Names

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Selegiline Transdermal

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No