Status:
COMPLETED
Tranylcypromine Treatment of Bipolar Depression
Lead Sponsor:
New York State Psychiatric Institute
Conditions:
Bipolar Disorder I or II
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This study seeks to investigate whether tranylcypromine (Parnate®) might be an effective treatment of bipolar depression. New treatments are needed, as there is little evidence that standard antidepre...
Eligibility Criteria
Inclusion
- History of Bipolar I, II
- Currently depressed (major depressive episode or depression NOS)
- Physically healthy or physically stable (i.e.,No changes in medical interventions in past three months or likely for the next three months)
- On stable and effective mood stabilizer or hypomania deemed sufficiently mild to not require a mood stabilizer.
- Prior adequate trial on at least one antidepressant.
- Able to follow a tyramine-free diet
- Must speak English
Exclusion
- Current psychosis
- past psychosis not occurring during an episode of mania or depression
- prior nonremission to tranylcypromine 60 mg/d (or greater)
- currently taking effective medication precluded while taking a Monoamine Oxidase Inhibitor (e.g., a psychostimulant or a serotonin re-uptake inhibitor)
- current (last six months) drug or alcohol abuse or dependence
- significant suicide risk
- significant cardiovascular risk
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01430455
Start Date
November 1 2011
End Date
September 1 2014
Last Update
March 15 2018
Active Locations (1)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032