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A Pilot Study Assessing EmSam in Bipolar Depression

Primary Purpose

Bipolar Depression

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
EmSam
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Depression focused on measuring Bipolar, depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EmSam

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 24, 2007
Last Updated
October 24, 2014
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00535262
Brief Title
A Pilot Study Assessing EmSam in Bipolar Depression
Official Title
A Pilot Study Assessing Efficacy, Safety, and Tolerability of EmSam in Bipolar Depression
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Terminated
Why Stopped
Current lack of medication support.
Study Start Date
March 2007 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Depression
Keywords
Bipolar, depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EmSam
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
EmSam
Other Intervention Name(s)
Selegiline Transdermal
Intervention Description
Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch
Primary Outcome Measure Information:
Title
Reduction of Depression CGI Score (<= 2)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Deliyannides, M.D.
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.depression-nyc.org/
Description
DES official site

Learn more about this trial

A Pilot Study Assessing EmSam in Bipolar Depression

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