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

This study has been completed.

Sponsor:

Information provided by:

National Institute of Mental Health (NIMH)

ClinicalTrials.gov Identifier:

NCT00080145

First received: March 24, 2004

Last updated: May 5, 2008

Last verified: May 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	March 24, 2004
Last Updated Date	May 5, 2008
Start Date ^ICMJE	February 2004
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: May 5, 2008)	Home Situations Questionnaire [ Time Frame: Week 24 ] [ Designated as safety issue: No ] Vineland Daily Living Skills Scale [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00080145 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 5, 2008)	Irritability subscale-Aberrant Behavioral Checklist [ Time Frame: Week 24 ] Clinical Global Impressions-Improvement (CGI-I) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	RUPP PI PDD: Drug and Behavioral Therapy for Children With Pervasive Developmental Disorders
Official Title ^ICMJE	Risperidone and Behavioral Therapy in Treatment of Children and Adolescents With Autistic Disorder
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.
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.
Study Type ^ICMJE	Interventional
Study Phase
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Child Development Disorders, Pervasive
Intervention ^ICMJE	Drug: Risperidone Behavioral: Behavior Therapy Drug: Aripiprazole
Study Arm (s)
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. Risperidone in children with autism and serious behavioral problems. N Engl J Med. 2002 Aug 1;347(5):314-21. 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. 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. Review. 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. 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; the 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 Oct 23; [Epub ahead of print]
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	124
Completion Date	September 2007
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	4 Years to 13 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00080145
Other Study ID Numbers ^ICMJE	U10 MH66764, U10 MH66766, U10 MH66768, DDTR BD-DD
Has Data Monitoring Committee	Yes
Responsible Party
Study Sponsor ^ICMJE	National Institute of Mental Health (NIMH)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Mental Health (NIMH)
Verification Date	May 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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