CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 450 enrolled
Drug / intervention
paliperidone +7 moredrug
Likely dose
paliperidone palmitate 234 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/NCT01157351
NCT01157351Phase 4Completed

A Fifteen-month, Prospective, Randomized, Active-controlled, Open-label, Flexible Dose Study of Paliperidone Palmitate Compared With Oral Antipsychotic Treatment in Delaying Time to Treatment Failure in Adults With Schizophrenia Who Have Been Incarcerated

Janssen Scientific Affairs, LLC·interventional·Posted Jul 7, 2010·Updated Apr 24, 2015

In Brief

A Phase 4 clinical trial evaluating paliperidone, risperidone, and 6 other interventions for Schizophrenia. Completed, enrolled 450 participants across 56 sites in 2 countries.

Detailed Summary

The study will assess the use of paliperidone palmitate compared with oral antipsychotic treatment in delaying time to a protocol-defined treatment failure over 15 months, in patients diagnosed with schizophrenia who have been incarcerated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 7, 2010
Enrollment StartMay 1, 2010
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 16.0 years ago

Interventions

paliperidonedrug

flexible dosing as prescribed by the study doctor for 15 months

risperidonedrug

flexible dosing as prescribed by the study doctor for 15 months

haloperidoledrug

flexible dosing as prescribed by the study doctor for 15 months

perphenazinedrug

flexible dosing as prescribed by the study doctor for 15 months

aripiprazoledrug

flexible dosing as prescribed by the study doctor for 15 months

quetiapinedrug

flexible dosing as prescribed by the study doctor for 15 months

paliperidone palmitatedrug

78, 117, 156, or 234 mg monthly injection for 15 months

olanzapinedrug

flexible dosing as prescribed by the study doctor for 15 months