A Pilot Study Assessing EmSam in Bipolar Depression
Information source: New York State Psychiatric Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Depression
Intervention: EmSam (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: New York State Psychiatric Institute Official(s) and/or principal investigator(s):
Deborah Deliyannides, M.D., Principal Investigator, Affiliation: New York State Psychiatric Institute
Summary
This pilot study will evaluate the efficacy of the monoamine oxidase inhibitor (MAOI)EmSam,
a selegiline transdermal system (STS), in bipolar depression.
Clinical Details
Official title: A Pilot Study Assessing Efficacy, Safety, and Tolerability of EmSam in Bipolar Depression
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Reduction of Depression CGI Score (<= 2)
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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)
Locations and Contacts
New York State Psychiatric Institute, New York, New York 10032, United States
Additional Information
DES official site Columbia University clinical trials website
Starting date: March 2007
Last updated: October 24, 2014
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