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Tranylcypromine Treatment of Bipolar Depression

Primary Purpose

Bipolar Disorder I or II

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tranylcypromine
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder I or II focused on measuring Major Depressive Episode, Depression NOS, Bipolar Disorder, Bipolar Disorder I, Bipolar Disorder II, Bipolar Depression, Major Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tranylcypromine

Arm Description

Active, open-label tranylcypromine treatment

Outcomes

Primary Outcome Measures

29 Item Hamilton Rating Scale for Depression (HamD29)
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.

Secondary Outcome Measures

Full Information

First Posted
September 6, 2011
Last Updated
February 15, 2018
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01430455
Brief Title
Tranylcypromine Treatment of Bipolar Depression
Official Title
Tranylcypromine Treatment of Bipolar Depression
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
November 2011 (Actual)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder I or II
Keywords
Major Depressive Episode, Depression NOS, Bipolar Disorder, Bipolar Disorder I, Bipolar Disorder II, Bipolar Depression, Major Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tranylcypromine
Arm Type
Experimental
Arm Description
Active, open-label tranylcypromine treatment
Intervention Type
Drug
Intervention Name(s)
Tranylcypromine
Other Intervention Name(s)
Parnate®
Intervention Description
Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study
Primary Outcome Measure Information:
Title
29 Item Hamilton Rating Scale for Depression (HamD29)
Description
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.
Time Frame
Hamilton 29 score at baseline (start date of medication) and week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Links:
URL
http://depression-nyc.org/
Description
Depression Evaluation Service

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Tranylcypromine Treatment of Bipolar Depression

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