Tranylcypromine Treatment of Bipolar Depression

Phase 4

Completed

• Conditions: Bipolar Disorder I or II
• Interventions: Drug: Tranylcypromine

• Registration Number: NCT01430455
• Lead Sponsor: New York State Psychiatric Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-06
• Study First Submitted QC: 2011-09-06
• Study First Posted: 2011-09-08
• Study Start: 2011-11
• Primary Completion: 2014-02
• Study Completion: 2014-09
• Results First Submitted: 2017-09-25
• Status Verified: 2018-02
• Results First Submitted QC: 2018-02-15
• Last Update Submitted: 2018-02-15
• Results First Posted: 2018-03-15
• Last Update Posted: 2018-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tranylcypromine	Tranylcypromine	Active, open-label tranylcypromine treatment

Primary Outcome Measures

Name	Time	Method
29 Item Hamilton Rating Scale for Depression (HamD29)	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.

Trial Locations

Locations (1)

New York State Psychiatric Institute; 🇺🇸 New York, New York, United States