NCT00080145

Brief Summary

This 24-week study will compare the safety and effectiveness of medication treatment alone (risperidone or aripiprazole) to medication treatment in combination with a parent management training program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

3 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

February 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2004

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

August 16, 2013

Status Verified

August 1, 2013

Enrollment Period

3.6 years

First QC Date

March 24, 2004

Last Update Submit

August 15, 2013

Conditions

Child Development Disorders, Pervasive

Keywords

Autistic DisorderAsperger Syndrome

Outcome Measures

Primary Outcomes (2)

  • Home Situations Questionnaire

    Week 24

  • Vineland Daily Living Skills Scale

    Week 24

Secondary Outcomes (2)

  • Irritability subscale-Aberrant Behavioral Checklist

    Week 24

  • Clinical Global Impressions-Improvement (CGI-I)

    Week 24

Study Arms (2)

risperidone plus parent management training

ACTIVE COMPARATOR
Drug: RisperidoneBehavioral: Behavior Therapy

risperidone only

ACTIVE COMPARATOR
Drug: Risperidone

Interventions

RisperidoneDRUG
risperidone onlyrisperidone plus parent management training
Behavior TherapyBEHAVIORAL
risperidone plus parent management training

Eligibility Criteria

Age4 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Psychotic Disorder
  • History of intolerance or nonresponse to risperidone
  • Pregnancy
  • History of neuroleptic malignant syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Yale University

New Haven, Connecticut, 06520, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (8)

  • 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

  • Scahill L, McCracken J, McDougle CJ, Aman M, Arnold LE, Tierney E, Cronin P, Davies M, Ghuman J, Gonzalez N, Koenig K, Lindsay R, Martin A, McGough J, Posey DJ, Swiezy N, Volkmar F, Ritz L, Vitiello B. Methodological issues in designing a multisite trial of risperidone in children and adolescents with autism. J Child Adolesc Psychopharmacol. 2001 Winter;11(4):377-88. doi: 10.1089/104454601317261555.

    PMID: 11838820BACKGROUND

  • McDougle CJ, Scahill L, McCracken JT, Aman MG, Tierney E, Arnold LE, Freeman BJ, Martin A, McGough JJ, Cronin P, Posey DJ, Riddle MA, Ritz L, Swiezy NB, Vitiello B, Volkmar FR, Votolato NA, Walson P. Research Units on Pediatric Psychopharmacology (RUPP) Autism Network. Background and rationale for an initial controlled study of risperidone. Child Adolesc Psychiatr Clin N Am. 2000 Jan;9(1):201-24.

    PMID: 10674197BACKGROUND

  • Scahill L, Jeon S, Boorin SJ, McDougle CJ, Aman MG, Dziura J, McCracken JT, Caprio S, Arnold LE, Nicol G, Deng Y, Challa SA, Vitiello B. Weight Gain and Metabolic Consequences of Risperidone in Young Children With Autism Spectrum Disorder. J Am Acad Child Adolesc Psychiatry. 2016 May;55(5):415-23. doi: 10.1016/j.jaac.2016.02.016. Epub 2016 Mar 7.

    PMID: 27126856DERIVED

  • Calarge CA, Ziegler EE, Del Castillo N, Aman M, McDougle CJ, Scahill L, McCracken JT, Arnold LE. Iron homeostasis during risperidone treatment in children and adolescents. J Clin Psychiatry. 2015 Nov;76(11):1500-5. doi: 10.4088/JCP.14m09258.

    PMID: 26301448DERIVED

  • Scahill L, McDougle CJ, Aman MG, Johnson C, Handen B, Bearss K, Dziura J, Butter E, Swiezy NG, Arnold LE, Stigler KA, Sukhodolsky DD, Lecavalier L, Pozdol SL, Nikolov R, Hollway JA, Korzekwa P, Gavaletz A, Kohn AE, Koenig K, Grinnon S, Mulick JA, Yu S, Vitiello B; Research Units on Pediatric Psychopharmacology Autism Network. Effects of risperidone and parent training on adaptive functioning in children with pervasive developmental disorders and serious behavioral problems. J Am Acad Child Adolesc Psychiatry. 2012 Feb;51(2):136-46. doi: 10.1016/j.jaac.2011.11.010. Epub 2011 Dec 23.

    PMID: 22265360DERIVED

  • Farmer C, Lecavalier L, Yu S, Eugene Arnold L, McDougle CJ, Scahill L, Handen B, Johnson CR, Stigler KA, Bearss K, Swiezy NB, Aman MG. Predictors and moderators of parent training efficacy in a sample of children with autism spectrum disorders and serious behavioral problems. J Autism Dev Disord. 2012 Jun;42(6):1037-44. doi: 10.1007/s10803-011-1338-2.

    PMID: 21822762DERIVED

  • Aman MG, McDougle CJ, Scahill L, Handen B, Arnold LE, Johnson C, Stigler KA, Bearss K, Butter E, Swiezy NB, Sukhodolsky DD, Ramadan Y, Pozdol SL, Nikolov R, Lecavalier L, Kohn AE, Koenig K, Hollway JA, Korzekwa P, Gavaletz A, Mulick JA, Hall KL, Dziura J, Ritz L, Trollinger S, Yu S, Vitiello B, Wagner A; Research Units on Pediatric Psychopharmacology Autism Network. Medication and parent training in children with pervasive developmental disorders and serious behavior problems: results from a randomized clinical trial. J Am Acad Child Adolesc Psychiatry. 2009 Dec;48(12):1143-54. doi: 10.1097/CHI.0b013e3181bfd669.

    PMID: 19858761DERIVED

MeSH Terms

Conditions

Child Development Disorders, PervasiveAutistic DisorderAsperger Syndrome

Interventions

RisperidoneBehavior Therapy

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersAutism Spectrum Disorder

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 24, 2004

First Posted

March 25, 2004

Study Start

February 1, 2004

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

August 16, 2013

Record last verified: 2013-08

Locations

US(3)