A Study of the Safety and Effectiveness of Risperidone Versus Placebo for the Treatment of Conduct Disorder in Children With Mild, Moderate, or Borderline Mental Retardation

Phase 3 Completed 118 enrolled Janssen Pharmaceutica N.V., Belgium

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of the study is to assess the effectiveness and safety of an oral solution of risperidone (an antipsychotic medication) versus placebo in the treatment of conduct disorder in children with mild, moderate, or borderline mental retardation.

Timeline

Start: —
Primary completion: —
Completion: 1998-10

Outcome

Met primary endpoint

paper The risperidone group showed significantly greater improvement than did the placebo group on the conduct problem subscale PMID 12153826 ↗

Publications

Results Aman MG, De Smedt G, Derivan A, Lyons B, Findling RL; Risperidone Disruptive Behavior Study Group. Double-blind, placebo-controlled study of risperidone for the treatment of disruptive behaviors in children with subaverage intelligence. Am J Psychiatry. 2002 Aug;159(8):1337-46. doi: 10.1176/appi.ajp.159.8.1337.

Drugs

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