A Study of the Effectiveness and Safety of Risperidone Versus Placebo in the Treatment of Children With Autistic Disorder and Other Pervasive Developmental Disorders (PDD)

Phase 3 Completed 80 enrolled Janssen-Ortho Inc., Canada

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of the study is to evaluate the effectiveness of an oral solution of risperidone (an antipsychotic medication) versus placebo in the treatment of behavioral symptoms in children with Pervasive Developmental Disorders (PDD).

Timeline

Start: 1999-08
Primary completion: —
Completion: 2001-12

Outcome

Met primary endpoint

paper Risperidone-treated subjects exhibited a 64% improvement over baseline in the irritability score almost double that of placebo-treated subjects (31%). PMID 15492353 ↗

paper the irritability subscale of the ABC (primary endpoint) PMID 15492353 ↗

Publications

Results Shea S, Turgay A, Carroll A, Schulz M, Orlik H, Smith I, Dunbar F. Risperidone in the treatment of disruptive behavioral symptoms in children with autistic and other pervasive developmental disorders. Pediatrics. 2004 Nov;114(5):e634-41. doi: 10.1542/peds.2003-0264-F. Epub 2004 Oct 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Risperidone	Other / unclassified	0.06 mg/kg	Oral