Completed

Risperidone and Behavioral Therapy in Treatment of Children and Adolescents With Autistic Disorder

What is being tested

Risperidone

+ Behavior Therapy

DrugBehavioral

Who is being recruted

Autism Spectrum Disorder+3

+ Autistic Disorder

+ Mental Disorders

From 4 to 13 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: February 2004

See protocol details

Summary

Principal SponsorYale University

Last updated: January 14, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2004

Actual date on which the first participant was enrolled.

PDD can be a profoundly disabling condition across social, emotional, and academic domains. Safe and effective treatments for PDD are needed. Participants are randomly assigned to receive either risperidone plus parent management training or risperidone alone for 24 weeks. Participants who show deterioration at Week 4 will be offered an alternative mediation treatment, aripiprazole. These participants will remain in their original treatment group (either med alone or med plus parent management training). After 6 months of treatment (Week 24), participants who respond to their treatment will be gradually discontinued from their medication treatment to learn if the response can be sustained without continued medication treatment (This phase of the study was ended in Nov. 2006) Adaptive and behavioral outcomes are assessed during the study.

Official TitleRisperidone and Behavioral Therapy in Treatment of Children and Adolescents With Autistic Disorder

NCT00080145

Principal SponsorYale University

Last updated: January 14, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

124 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 4 to 13 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autism Spectrum DisorderAutistic DisorderMental DisordersDevelopmental DisabilitiesChild Development Disorders, PervasiveNeurodevelopmental Disorders

Criteria

Inclusion Criteria: * Autistic Disorder, Asperger's Disorder, or Pervasive Developmental Disorder not otherwise specified * Weight \> 30 lbs * IQ \>= 35 or mental age of at least 18 months Exclusion Criteria: * Psychotic Disorder * History of intolerance or nonresponse to risperidone * Pregnancy * History of neuroleptic malignant syndrome

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

Group II

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

Yale University

New Haven, United StatesSee the location

Suspended

Indiana University

Indianapolis, United States

Suspended

Ohio State University

Columbus, United States

Completed3 Study Centers