Tranylcypromine Treatment of Bipolar Depression

Study Overview
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Brief Summary
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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.

Official Title
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Tranylcypromine Treatment of Bipolar Depression

Conditions
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Bipolar Disorder I or II

Intervention / Treatment
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* Drug: Tranylcypromine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranylcypromine<br>Active, open-label tranylcypromine treatment | Drug: Tranylcypromine<br>* Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study<br>* Other names: Parnate®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 29 Item Hamilton Rating Scale for Depression (HamD29) | 29 Item Hamilton Rating Scale for Depression (HamD29) is the 29 item version of the most common depression rating scale. The scores represented here are the average scores at baseline and after 16 weeks of open label treatment. The scale is rated from 0-89 with higher scores representing a more depressed state. | Hamilton 29 score at baseline (start date of medication) and week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major Depressive Episode, Depression NOS, Bipolar Disorder, Bipolar Disorder I, Bipolar Disorder II, Bipolar Depression, Major Depression