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Child Development Disorders, PervasiveNCT00080145

RUPP PI PDD: Drug and Behavioral Therapy for Children With Pervasive Developmental Disorders

A study testing Risperidone and Behavior Therapy in people with Child Development Disorders, Pervasive, run by Yale University at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 13 years
Conditions the study is for
Child Development Disorders, Pervasive
What is being tested?
Risperidone and Behavior Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
3 sitesUnited States
Study dates
Feb 2004to Sep 2007
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 13 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Ohio State University

    Columbus, Ohio, 43210

  • Indiana University

    Indianapolis, Indiana, 46202

  • Yale University

    New Haven, Connecticut, 06520

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Being tested
Risperidone, Behavior Therapy
Keywords
Autistic Disorder, Asperger Syndrome
Medical subject headings
Child Development Disorders, Pervasive, Autistic Disorder, Asperger Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00080145
Study groupRoleWhat they receive
risperidone plus parent management trainingActive comparatorNot described
Receives: Drug: Risperidone; Behavioral: Behavior Therapy
risperidone onlyActive comparatorNot described
Receives: Drug: Risperidone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Home Situations Questionnaire

    Measured: Week 24

  2. Vineland Daily Living Skills Scale

    Measured: Week 24

Secondary outcomes (2)

  1. Irritability subscale-Aberrant Behavioral Checklist

    Measured: Week 24

  2. Clinical Global Impressions-Improvement (CGI-I)

    Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2004 (estimated)
  2. Study startFeb 2004
  3. Primary completionSep 2007
  4. Study completionSep 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00080145
Sponsor's protocol ID
U10MH066764
Other IDs
U10MH066764, U10MH066766, U10MH066768, DDTR BD-DD
Status last verified
Aug 2013
First submitted
24 Mar 2004
Last updated
16 Aug 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 12151468

  • 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.

    PubMed 11838820

  • 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.

    PubMed 10674197

  • 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.

    PubMed 27126856

  • 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.

    PubMed 26301448

  • 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.

    PubMed 22265360

  • 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.

    PubMed 21822762

  • 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.

    PubMed 19858761

Questions about this trial

What is this clinical trial studying?

A study testing Risperidone and Behavior Therapy in people with Child Development Disorders, Pervasive, run by Yale University at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Home Situations Questionnaire (time frame: Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00080145, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2013.

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