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Tranylcypromine Treatment of Bipolar Depression | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Tranylcypromine Treatment of Bipolar Depression

NCT01430455•New York State Psychiatric Institute

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 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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

New York State Psychiatric Institute

New York, New York, United States

Key Dates

Start Date

November 1, 2011

Primary Completion Date

February 1, 2014

Completion Date

September 1, 2014

Last Updated

March 15, 2018

Enrollment

ACTUAL participants

Conditions

Bipolar Disorder I or II

Interventions

Tranylcypromine

DRUG

ALTO-100 in Bipolar Disorder With Depression (BD-D)

NCT06656416

Bipolar Disorder I or II With a Major Depressive Episode

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NOT_YET_RECRUITINGNA

A Compassionate-focused Intervention for Older People with Bipolar Disorder

NCT06882590

Bipolar Disorder I or II

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 15, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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