Tranylcypromine Treatment of Bipolar Depression
| Status: | Completed |
|---|---|
| Conditions: | Depression, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/17/2018 |
| Start Date: | November 2011 |
| End Date: | September 2014 |
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 antidepressants are effective in treating this condition, and the two antipsychotic
medications that have indications for bipolar depression can cause substantial side effects.
This study will focus specifically on currently depressed outpatients having a bipolar
history for whom at least one standard antidepressant medication was ineffective. Patients
will be treated openly with tranylcypromine for 8-10 months, depending on treatment response.
treatment of bipolar depression. New treatments are needed, as there is little evidence that
standard antidepressants are effective in treating this condition, and the two antipsychotic
medications that have indications for bipolar depression can cause substantial side effects.
This study will focus specifically on currently depressed outpatients having a bipolar
history for whom at least one standard antidepressant medication was ineffective. Patients
will be treated openly with tranylcypromine for 8-10 months, depending on treatment response.
Inclusion Criteria:
1. History of Bipolar I, II
2. Currently depressed (major depressive episode or depression NOS)
3. Physically healthy or physically stable (i.e.,No changes in medical interventions in
past three months or likely for the next three months)
4. On stable and effective mood stabilizer or hypomania deemed sufficiently mild to not
require a mood stabilizer.
5. Prior adequate trial on at least one antidepressant.
6. Able to follow a tyramine-free diet
7. Must speak English
Exclusion Criteria:
1. Current psychosis
2. past psychosis not occurring during an episode of mania or depression
3. prior nonremission to tranylcypromine 60 mg/d (or greater)
4. currently taking effective medication precluded while taking a Monoamine Oxidase
Inhibitor (e.g., a psychostimulant or a serotonin re-uptake inhibitor)
5. current (last six months) drug or alcohol abuse or dependence
6. significant suicide risk
7. significant cardiovascular risk
We found this trial at
1
site
1051 Riverside Dr
New York, New York 10032
New York, New York 10032
646-774-5000
Principal Investigator: Jonathan W Stewart, M.D.
Phone: 212-543-5605
New York State Psychiatric Institute The New York State Psychiatric Institute (NYSPI), established in 1895,...
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