A Pilot Study Assessing EmSam in Bipolar Depression

Stopped early · Phase 4

Conditions studied: Bipolar Depression

In brief

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

Key facts

Study ID

NCT00535262

Run by

New York State Psychiatric Institute

People needed

3

Starts

2007-03-01

Expected to finish

2012-02-01

Last updated by the study team

2014-10-28

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• New York State Psychiatric Institute — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.