drugset / Trial / NCT01009047

An Efficacy and Safety Study of Extended-Release (ER) Paliperidone in Adolescent Participants With Schizophrenia

NCT01009047

Phase 3 Completed 228 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of extended-release (ER) paliperidone compared to aripiprazole (atypical antipsychotic) in symptomatic (having symptoms) adolescent participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations \[imagining things\], and withdrawal into the self) .

Timeline

Start
2009-12
Primary completion
2012-06
Completion
2012-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aripiprazole Other / unclassified 5 mg Oral
Comparator Aripiprazole Other / unclassified 10 mg Oral
Comparator Aripiprazole Other / unclassified 15 mg Oral
Subject Paliperidone Unknown 3 mg Oral
Subject Paliperidone Unknown 6 mg Oral
Subject Paliperidone Unknown 9 mg Oral

Indications