A Pilot Study Assessing EmSam in Bipolar Depression

• Status: Terminated
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Treatments: Selegiline

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)