2001
Methodological Issues in Designing a Multisite Trial of Risperidone in Children and Adolescents with Autism
Scahill L, McCracken J, McDougle C, Aman M, Arnold L, Tierney E, Cronin P, Davies M, Ghuman J, Gonzalez N, Koenig K, Lindsay R, Martin A, McGough J, Posey D, Swiezy N, Volkmar F, Ritz L, Vitiello B. Methodological Issues in Designing a Multisite Trial of Risperidone in Children and Adolescents with Autism. Journal Of Child And Adolescent Psychopharmacology 2001, 11: 377-388. PMID: 11838820, DOI: 10.1089/104454601317261555.Peer-Reviewed Original ResearchConceptsPlacebo-controlled studyPlacebo-controlled discontinuation studyAutistic disorderSafety of risperidoneStudy of RisperidoneStandard pharmacological treatmentSelf-injurious behaviorDiscontinuation studyPharmacological treatmentClinical trialsInclusion criteriaLong-term effectsSevere tantrumsTrial designClinical relevanceClinical practiceLength of trialRisperidoneMultisite trialStudy designContinuous treatmentTrialsTreatment effectsDisordersMaintenance phase
2000
Research Units on Pediatric Psychopharmacology (Rupp) Autism Network Background and Rationale for an Initial Controlled Study of Risperidone
McDougle C, Scahill L, McCracken J, Aman M, Tierney E, Arnold L, Freeman B, Martin A, McGough J, Cronin P, Posey D, Riddle M, Ritz L, Swiezy N, Vitiello B, Volkmar F, Votolato N, Walson P. Research Units on Pediatric Psychopharmacology (Rupp) Autism Network Background and Rationale for an Initial Controlled Study of Risperidone. Child And Adolescent Psychiatric Clinics Of North America 2000, 9: 201-224. PMID: 10674197, DOI: 10.1016/s1056-4993(18)30142-1.Peer-Reviewed Original ResearchConceptsOpen-label trialDA neuronal systemsSafety of risperidoneStudy of RisperidonePlacebo-controlled studyUse of risperidoneExtrapyramidal side effectsTarget of pharmacotherapyTreatment of childrenImpaired social behaviorLong-term effectivenessPreclinical evidenceReceptor blockadeTypical antipsychoticsControlled StudyFirst drugPathophysiology of autismLower riskShort-term benefitsSide effectsRisperidonePotent effectsSymptoms of autismNeuronal systemsEnhanced efficacy
1997
Risperidone Treatment of Children and Adolescents With Pervasive Developmental Disorders: A Prospective, Open-Label Study
MCDOUGLE C, HOLMES J, BRONSON M, ANDERSON G, VOLKMAR F, PRICE L, COHEN D. Risperidone Treatment of Children and Adolescents With Pervasive Developmental Disorders: A Prospective, Open-Label Study. Journal Of The American Academy Of Child & Adolescent Psychiatry 1997, 36: 685-693. PMID: 9136504, DOI: 10.1097/00004583-199705000-00020.Peer-Reviewed Original ResearchConceptsPervasive developmental disorderDevelopmental disordersRisperidone treatmentClinical Global Impression ScaleOpen-label studyOpen-label trialPlacebo-controlled studyCommon side effectsEfficacy of risperidoneShort-term safetyGlobal Impression ScaleGlobal improvement itemBehavioral ratingsChildhood disintegrative disorderSocial relatednessTreatment of childrenAsperger's disorderRepetitive behaviorsAutistic disorderBehavioral symptomsBaseline visitMean ageImpression ScaleAdolescentsOptimal dose