CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 7 enrolled
Drug / intervention
Tranylcyprominedrug
Likely dose
Tranylcypromine 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01430455
NCT01430455Phase 4Completed
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Tranylcypromine Treatment of Bipolar Depression

New York State Psychiatric Institute·interventional·Posted Sep 8, 2011·Updated Mar 15, 2018

In Brief

A Phase 4 clinical trial evaluating Tranylcypromine for Bipolar Disorder I or II. Completed, enrolled 7 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder I or II
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 8, 2011
Enrollment StartNov 1, 2011
Primary CompletionFeb 1, 2014
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.8 years ago

Interventions

Tranylcyprominedrug

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