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

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

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Paliperidone Extended Release (ER) vs Aripiprazole; p = 0.935; Least-squares (LS) mean difference 0.1 (95% CI -3.46 to 3.76); ANCOVA; NCT01009047 ↗

paper There was no significant difference in change in PANSS total scores from baseline to day 56 (primary endpoint) PMID 25617253 ↗

Publications

Savitz AJ, Lane R, Nuamah I, Gopal S, Hough D. Efficacy and safety of paliperidone extended release in adolescents with schizophrenia: a randomized, double-blind study. J Am Acad Child Adolesc Psychiatry. 2015 Feb;54(2):126-137.e1. doi: 10.1016/j.jaac.2014.11.009. Epub 2014 Nov 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
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