RUPP PI PDD: Drug and Behavioral Therapy for Children With Pervasive Developmental Disorders
NCT ID: NCT00080145
Last Updated: 2013-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
124 participants
INTERVENTIONAL
2004-02-29
2007-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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risperidone plus parent management training
Risperidone
Behavior Therapy
risperidone only
Risperidone
Interventions
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Risperidone
Behavior Therapy
Eligibility Criteria
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Inclusion Criteria
* Weight \> 30 lbs
* IQ \>= 35 or mental age of at least 18 months
Exclusion Criteria
* History of intolerance or nonresponse to risperidone
* Pregnancy
* History of neuroleptic malignant syndrome
4 Years
13 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Yale University
OTHER
Responsible Party
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Denis Sukhodolsky
Principal Investigator
Locations
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Yale University
New Haven, Connecticut, United States
Indiana University
Indianapolis, Indiana, United States
Ohio State University
Columbus, Ohio, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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DDTR BD-DD
Identifier Type: -
Identifier Source: secondary_id