A Pilot Study Assessing EmSam in Bipolar Depression

Bipolar Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00535262
• Other study ID #: #5439
• Status: Terminated
• Phase: Phase 4
• First received: September 24, 2007
• Last updated: October 24, 2014
• Start date: March 2007
• Est. completion date: February 2012

Study information

• Verified date: May 2013
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

Drug:
• EmSam
Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

•   Columbia University clinical trials website
•   DES official site