RUPP PI PDD: Drug and Behavioral Therapy for Children With Pervasive Developmental Disorders - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00080145

Purpose

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.

Condition	Intervention
Child Development Disorders, Pervasive	Drug: Risperidone Behavioral: Behavior Therapy Drug: Aripiprazole

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Risperidone and Behavioral Therapy in Treatment of Children and Adolescents With Autistic Disorder

Resource links provided by NLM:

Genetics Home Reference related topics: Asperger syndrome

MedlinePlus related topics: Autism Child Development Developmental Disabilities Infant and Newborn Development Toddler Development

Drug Information available for: Risperidone Aripiprazole

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Irritability subscale-Aberrant Behavioral Checklist [ Time Frame: Week 24 ]
Clinical Global Impressions-Improvement (CGI-I) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Enrollment:	124
Study Start Date:	February 2004
Study Completion Date:	September 2007

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.

Eligibility

Ages Eligible for Study:	4 Years to 13 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00080145

Locations

United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

More Information

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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]

ClinicalTrials.gov Identifier:	NCT00080145 History of Changes
Other Study ID Numbers:	U10 MH66764, U10 MH66766, U10 MH66768, DDTR BD-DD
Study First Received:	March 24, 2004
Last Updated:	May 5, 2008
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Autistic Disorder
Asperger Syndrome

Additional relevant MeSH terms:

Autistic Disorder
Developmental Disabilities
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Risperidone
Aripiprazole
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on February 12, 2012