Tranylcypromine Treatment of Bipolar Depression

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2014

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Tranylcypromine
    • Active, open-label tranylcypromine treatment

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • New York State Psychiatric Institute
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.