Phase 4 N=7 Treatment

Tranylcypromine Treatment of Bipolar Depression

Bipolar Disorder I or II

Bottom Line

View on ClinicalTrials.gov: NCT01430455 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2018

Primary outcome: Primary: 29 Item Hamilton Rating Scale for Depression (HamD29) — 27.0; 5.8 Hamilton Depression score

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Tranylcypromine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: New York State Psychiatric Institute
Primary completion: Feb 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY 29 Item Hamilton Rating Scale for Depression (HamD29)	27.0; 5.8	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01430455). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.