A Pilot Study Assessing EmSam in Bipolar Depression

This study has been terminated.
(Current lack of medication support.)
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00535262
First received: September 24, 2007
Last updated: October 24, 2014
Last verified: May 2013
  Purpose

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


Condition Intervention Phase
Bipolar Depression
Drug: EmSam
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study Assessing Efficacy, Safety, and Tolerability of EmSam in Bipolar Depression

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Reduction of Depression CGI Score (<= 2) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

    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.



Enrollment: 3
Study Start Date: March 2007
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: EmSam
Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch
Other Name: Selegiline Transdermal

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00535262

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Deborah Deliyannides, M.D. New York State Psychiatric Institute
  More Information

Additional Information:
No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00535262     History of Changes
Other Study ID Numbers: #5439
Study First Received: September 24, 2007
Results First Received: October 1, 2014
Last Updated: October 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
Bipolar
depression

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 30, 2014