Clinical trial NCT00535262: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Bipolar Depression
Keywords: Bipolar
depression
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2007-09-26
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Reduction of Depression CGI Score (<= 2)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Deborah Deliyannides, M.D.
role: PRINCIPAL_INVESTIGATOR
References: