A Pilot Study Assessing EmSam in Bipolar Depression

Phase 4

Terminated

• Conditions: Bipolar Depression
• Interventions: Drug: EmSam

• Registration Number: NCT00535262
• Lead Sponsor: New York State Psychiatric Institute

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-09-24
• Study First Submitted QC: 2007-09-24
• Study First Posted: 2007-09-26
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2013-05
• Results First Submitted: 2014-10-01
• Results First Submitted QC: 2014-10-24
• Last Update Submitted: 2014-10-24
• Results First Posted: 2014-10-28
• Last Update Posted: 2014-10-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EmSam	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.

Primary Outcome Measures

Name	Time	Method
Reduction of Depression CGI Score (<= 2)	8 weeks	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.

Trial Locations

Locations (1)

New York State Psychiatric Institute; 🇺🇸 New York, New York, United States