Tranylcypromine Treatment of Bipolar Depression

NCT01430455 | Completed Phase 4 Results DMC

• 1 other identifier: 6333
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder I or II

Keywords

Major Depressive Episode; Depression NOS; Bipolar Disorder; Bipolar Disorder I; Bipolar Disorder II; Bipolar Depression; Major Depression

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Tranylcypromine

EXPERIMENTAL

Active, open-label tranylcypromine treatment

Drug: Tranylcypromine

Interventions

Tranylcypromine DRUG

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

Also known as: Parnate®

Tranylcypromine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Links

• Depression Evaluation Service

MeSH Terms

Conditions

Depression; Bipolar Disorder; Depressive Disorder, Major

Interventions

Tranylcypromine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Depressive Disorder

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Jonathan W. Stewart
• Organization: Depression Evaluation Service (New York State Psychiatric Institute)

jws6@nyspi.columbia.edu

646-774-8070

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2011
• First Posted: September 8, 2011
• Study Start: November 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 15, 2018
• Results First Posted: March 15, 2018

Record last verified: 2018-02

Locations

US (1)