The Efficacy and Safety of Risperidone in the Treatment of Adolescents With Schizophrenia

Phase 3 Completed 279 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

RandomizedParallel-groupDouble-blindTreatment

Summary

A clinical study to compare the safety and effectiveness of two different dose ranges of risperidone solution in the treatment of adolescents with a diagnosis of schizophrenia.

Timeline

Start: 2001-04
Primary completion: —
Completion: 2006-03

Outcome

Met primary endpoint

paper Mean total Positive and Negative Syndrome Scale (PANSS) score improved significantly (P<0.001; effect size=0.49) from baseline to end-point for regimen A PMID 19182179 ↗

Publications

Haas M, Eerdekens M, Kushner S, Singer J, Augustyns I, Quiroz J, Pandina G, Kusumakar V. Efficacy, safety and tolerability of two dosing regimens in adolescent schizophrenia: double-blind study. Br J Psychiatry. 2009 Feb;194(2):158-64. doi: 10.1192/bjp.bp.107.046177.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Risperidone	Other / unclassified	0.007 mg/kg	Oral
Subject	Risperidone	Other / unclassified	0.012 mg/kg	Oral
Subject	Risperidone	Other / unclassified	0.07 mg/kg	Oral
Subject	Risperidone	Other / unclassified	0.12 mg/kg	Oral
Subject	Risperidone	Other / unclassified	0.35 mg	Oral
Subject	Risperidone	Other / unclassified	0.6 mg	Oral
Subject	Risperidone	Other / unclassified	3.5 mg	Oral
Subject	Risperidone	Other / unclassified	6 mg	Oral