Tranylcypromine Treatment of Bipolar Depression

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.

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Key information

Conditions

Bipolar Disorder I or II Behavior Behavioral Symptoms Bipolar Disorder Bipolar and Related Disorders Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

New York State Psychiatric Institute

New York, 10032, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranylcypromine

Drug

Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study

Other names: Parnate®

Primary outcomes

29 Item Hamilton Rating Scale for Depression (HamD29)

Time frame: Hamilton 29 score at baseline (start date of medication) and week 16

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.

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Sep 8, 2011
Registry last updated: Mar 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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