NCT00005014

Brief Summary

This study is designed to determine the effectiveness of risperidone, a drug treatment for the interfering symptoms of Autistic Disorder in children and adolescents between the ages of 5 and 17. Between 100 and 120 patients will be participating in this research study at five academic medical centers in the United States. The primary aim of the treatment is to reduce impairing behavioral symptoms such as aggression, explosive outbursts, or self-injurious behavior, without significant side effects. A secondary aim is to evaluate possible improvement in the level of social relatedness, attention, motor coordination, and short-term memory. This study is a placebo-controlled, double-blind study (neither the investigators nor patients know if the treatment being given is risperidone or an inactive substance, placebo). Patients will be asked to participate for 6 to 8 months. For the first 8 weeks, patients will receive either risperidone or placebo, randomly chosen. At the end of the 8 weeks, those patients who have improved and were on risperidone will be asked to continue on this medication for another 4 months. The last two months of the study are again double-blind (neither patients nor investigators know treatment). Patients will either continue risperidone treatment or be gradually tapered from risperidone (placebo-substitution). This blinded discontinuation phase will last 2 months during which patients will be closely monitored for recurrence or worsening of symptoms. Patients who have been treated with placebo in the first 8 weeks of the study and have not improved will be treated with risperidone. Weekly visits are required for the first 8 weeks of the study, monthly visits for the following 4 months, and weekly visits during the last 2 months of the study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 1997

Typical duration for phase_3

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1997

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2000

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2000

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2001

Completed
Last Updated

April 17, 2014

Status Verified

August 1, 2010

First QC Date

March 31, 2000

Last Update Submit

April 16, 2014

Conditions

Autistic Disorder

Keywords

Autistic DisorderRisperidone

Interventions

RisperidoneDRUG

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Males and females between the ages of 5 and 17 years 2 months.
  • Weight of 15 kg or greater.
  • DSM-IV diagnosis of Autistic Disorder.
  • Inpatient or outpatient.
  • Medication free for at least 2 weeks for all psychotropic medications (4 weeks for fluoxetine or depot neuroleptics).
  • Anticonvulsants used for treatment of seizure disorder permitted if the dosage has been stable for 4 weeks and patient seizure free for at least 6 months.
  • Clinical Global Impression Severity score of at least 4 and a)18 or greater on the Irritability Scale of the Aberrant Behavior Checklist or b) .5 total score on the Ritvo-Freeman scale.
  • Mental age of at least 18 months.
  • Negative pregnancy test

You may not qualify if:

  • IQ below 18 months.
  • Females with a positive pregnancy test. - Evidence of a prior adequate trial with risperidone.
  • Evidence of hypersensitivity to risperidone.
  • Past history of neuroleptic malignant syndrome.
  • DSM-IV diagnosis of Pervasive Developmental Disorder other than Autistic Disorder.
  • Significant medical condition such as heart disease, hypertension, liver or renal failure, pulmonary disease, or unstable seizure disorder.
  • Weight less than 15 kg.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

UCLA

Los Angeles, California, 90024, United States

Location

Yale Univ

New Haven, Connecticut, 06520, United States

Location

Indiana Univ / Riley Hosp for Children

Indianapolis, Indiana, 46202, United States

Location

Kennedy Krieger Institute

Baltimore, Maryland, 21231, United States

Location

Ohio State Univ

Columbus, Ohio, 43210, United States

Location

Related Publications (5)

  • McCracken JT, McGough J, Shah B, Cronin P, Hong D, Aman MG, Arnold LE, Lindsay R, Nash P, Hollway J, McDougle CJ, Posey D, Swiezy N, Kohn A, Scahill L, Martin A, Koenig K, Volkmar F, Carroll D, Lancor A, Tierney E, Ghuman J, Gonzalez NM, Grados M, Vitiello B, Ritz L, Davies M, Robinson J, McMahon D; Research Units on Pediatric Psychopharmacology Autism Network. Risperidone in children with autism and serious behavioral problems. N Engl J Med. 2002 Aug 1;347(5):314-21. doi: 10.1056/NEJMoa013171.

    PMID: 12151468BACKGROUND

  • Aman MG, Arnold LE, McDougle CJ, Vitiello B, Scahill L, Davies M, McCracken JT, Tierney E, Nash PL, Posey DJ, Chuang S, Martin A, Shah B, Gonzalez NM, Swiezy NB, Ritz L, Koenig K, McGough J, Ghuman JK, Lindsay RL. Acute and long-term safety and tolerability of risperidone in children with autism. J Child Adolesc Psychopharmacol. 2005 Dec;15(6):869-84. doi: 10.1089/cap.2005.15.869.

    PMID: 16379507BACKGROUND

  • Williams SK, Scahill L, Vitiello B, Aman MG, Arnold LE, McDougle CJ, McCracken JT, Tierney E, Ritz L, Posey DJ, Swiezy NB, Hollway J, Cronin P, Ghuman J, Wheeler C, Cicchetti D, Sparrow S. Risperidone and adaptive behavior in children with autism. J Am Acad Child Adolesc Psychiatry. 2006 Apr;45(4):431-9. doi: 10.1097/01.chi.0000196423.80717.32.

    PMID: 16601648BACKGROUND

  • Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.

    PMID: 37811711DERIVED

  • Levine SZ, Kodesh A, Goldberg Y, Reichenberg A, Furukawa TA, Kolevzon A, Leucht S. Initial severity and efficacy of risperidone in autism: Results from the RUPP trial. Eur Psychiatry. 2016 Feb;32:16-20. doi: 10.1016/j.eurpsy.2015.11.004. Epub 2016 Jan 21.

    PMID: 26802979DERIVED

MeSH Terms

Conditions

Autistic Disorder

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Michael Aman

    Ohio State Univ

    PRINCIPAL INVESTIGATOR

  • James McCracken

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

  • Christopher J McDougle

    Indiana Univ / Riley Hosp for Children

    PRINCIPAL INVESTIGATOR

  • Elaine Tierney

    Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

    PRINCIPAL INVESTIGATOR

  • Fred Volkmar

    Yale Univ

    PRINCIPAL INVESTIGATOR

  • Benedetto Vitiello, NIMH Coordinator

    Natl Institute of Mental Health

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

March 31, 2000

First Posted

April 3, 2000

Study Start

October 1, 1997

Study Completion

February 1, 2001

Last Updated

April 17, 2014

Record last verified: 2010-08

Locations

US(5)