Tranylcypromine Treatment of Bipolar Depression

February 15, 2018 updated by: New York State Psychiatric Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tranylcypromine
Active, open-label tranylcypromine treatment
Drug: Tranylcypromine
Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study
Other Names:
  • Parnate®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Hamilton 29 score at baseline (start date of medication) and week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2011

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

September 6, 2011

First Submitted That Met QC Criteria

September 6, 2011

First Posted (Estimate)

September 8, 2011

Study Record Updates

Last Update Posted (Actual)

March 15, 2018

Last Update Submitted That Met QC Criteria

February 15, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6333

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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