CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 54 enrolled
Drug / intervention
paliperidone +2 moredrug
Likely dose
paliperidone 5 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/NCT01134731
NCT01134731Phase 4Completed
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Paliperidone and Lithium in the Treatment of Suicidality - Treatment Indication and Epigenetic Regulation

University of Alabama at Birmingham·interventional·Posted Jun 2, 2010·Updated Mar 3, 2016

In Brief

A Phase 4 clinical trial evaluating paliperidone, lithium, and 1 other intervention for Major Depressive Disorder and Suicidal Ideation. Completed, enrolled 54 participants across 1 site.

Detailed Summary

The study aims to use a combined clinical and translational approach to identify an efficient pharmacotherapy for the acute management of suicidality and the epigenetic regulation associated with the treatment.The primary objective is a clinical trial to compare the efficacy of paliperidone versus lithium and placebo as adjunctive therapy to the standard of care antidepressants in the acute management of suicidality in depressed subjects. Specific Aims 1 and 2 are described in detail below. Analysis for Specific Aim 2 is still underway.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder, Suicidal Ideation
CountriesUnited States
CollaboratorsAmerican Foundation for Suicide Prevention, Ortho-McNeil Janssen Scientific Affairs, LLC

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2, 2010
Enrollment StartMay 1, 2010
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 16.1 years ago

Interventions

paliperidonedrug

1-5 mg daily (QD)

lithiumdrug

300-1500mg QD

Placebodrug

1-5 placebo capsules