Tranylcypromine Treatment of Bipolar Depression

Bipolar Disorder I or II Clinical Trial

Official title:

Tranylcypromine Treatment of Bipolar Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01430455
• Other study ID #: 6333
• Status: Completed
• Phase: Phase 4
• First received: September 6, 2011
• Last updated: February 15, 2018
• Start date: November 2011
• Est. completion date: September 2014

Study information

• Verified date: February 2018
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: September 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Bipolar Disorder I or II
• Depression
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Hamilton 29 score at baseline (start date of medication) and week 16

External Links

•   Depression Evaluation Service