MedTrace Logo

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)

NCT00261508 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2011-01-24

No results posted yet for this study

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).

Conditions

  • DCild Development Disorders, Pervasive
  • Autistic Disorder
  • Developmental Disabilities
  • Asperger Syndrome
  • Rett Syndrome

Interventions

DRUG

risperidone

Sponsors & Collaborators

  • Janssen-Ortho Inc., Canada

    lead INDUSTRY

Principal Investigators

  • Janssen-Ortho Inc. Clinical Trial · Janssen-Ortho Inc., Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-08-31
Completion
2001-12-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00261508 on ClinicalTrials.gov