Open-label Study of Flexible-dose Paliperidone ER (Extended Release) to Treat Adolescent Schizophrenia.

Phase 3 Completed 400 enrolled Janssen Research & Development, LLC

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this open-label study is to evaluate the long-term (6-month) safety and tolerability of extended-release paliperidone, an atypical antipsychotic, given in flexible dosages to adolescents with schizophrenia.

Timeline

Start: 2007-06
Primary completion: 2012-07
Completion: 2012-07

Publications

Gopal S, Lane R, Nuamah I, Copenhaver M, Singh J, Hough D, Bach M, Savitz A. Evaluation of Potentially Prolactin-Related Adverse Events and Sexual Maturation in Adolescents with Schizophrenia Treated with Paliperidone Extended-Release (ER) for 2 Years: A Post Hoc Analysis of an Open-Label Multicenter Study. CNS Drugs. 2017 Sep;31(9):797-808. doi: 10.1007/s40263-017-0437-9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Paliperidone	Unknown	1.5 mg	Oral
Subject	Paliperidone	Unknown	12 mg	Oral

Open-label Study of Flexible-dose Paliperidone ER (Extended Release) to Treat Adolescent Schizophrenia.

Summary

Timeline

Publications

Drugs

Indications