2006
Parent satisfaction in a multi-site acute trial of risperidone in children with autism: a social validity study
Tierney E, Aman M, Stout D, Pappas K, Arnold LE, Vitiello B, Scahill L, McDougle C, McCracken J, Wheeler C, Martin A, Posey D, Shah B. Parent satisfaction in a multi-site acute trial of risperidone in children with autism: a social validity study. Psychopharmacology 2006, 191: 149-157. PMID: 17123125, DOI: 10.1007/s00213-006-0604-z.Peer-Reviewed Original ResearchConceptsClinical trialsClinical trial proceduresParent satisfactionDouble-blind clinical trialRandomized clinical trialsTrial proceduresResearch participationClinical responseAcute trialTreatment outcomesActive drugSimilar childrenStudy proceduresTrialsPharmacological researchAutistic disorderLearning TestPlaceboChildren's research participationEthnic minority subjectsChildrenRisperidoneWhite participantsGood allianceDrugsEffects of Short- and Long-Term Risperidone Treatment on Prolactin Levels in Children with Autism
Anderson GM, Scahill L, McCracken JT, McDougle CJ, Aman MG, Tierney E, Arnold LE, Martin A, Katsovich L, Posey DJ, Shah B, Vitiello B. Effects of Short- and Long-Term Risperidone Treatment on Prolactin Levels in Children with Autism. Biological Psychiatry 2006, 61: 545-550. PMID: 16730335, DOI: 10.1016/j.biopsych.2006.02.032.Peer-Reviewed Original ResearchConceptsRisperidone-induced increasesLong-term risperidone treatmentProlactin levelsRisperidone treatmentSerum prolactinOpen-label followWeeks of risperidoneBaseline prolactin levelsEffects of ShortPlacebo groupProlactin elevationReceptor polymorphismsWeek 8Baseline levelsMean increaseProlactinRisperidoneSerum samplesAdverse effectsPlaceboChildrenTreatmentMonthsDRD2 allelesAdolescents
2005
Acute and Long-Term Safety and Tolerability of Risperidone in Children with Autism
Aman MG, Arnold M, McDougle CJ, Vitiello B, Scahill L, Davies M, McCracken JT, Tierney E, Nash PL, Posey DJ, Chuang S, Martin A, Shah B, Gonzalez NM, Swiezy NB, Ritz L, Koenig K, McGough J, Ghuman JK, Lindsay RL. Acute and Long-Term Safety and Tolerability of Risperidone in Children with Autism. Journal Of Child And Adolescent Psychopharmacology 2005, 15: 869-884. PMID: 16379507, DOI: 10.1089/cap.2005.15.869.Peer-Reviewed Original ResearchConceptsSimpson-Angus Neurological Rating ScaleAbnormal Involuntary Movement ScaleAdverse eventsBody mass indexAcute trialTreatment-emergent adverse eventsTolerability of risperidoneCommon adverse eventsMost adverse eventsOpen-label extensionPlacebo-controlled trialMonths of treatmentUnanticipated adverse eventsSame adverse eventsLong-term safetyNeurological Rating ScaleOpen-label risperidoneRisperidone groupRisperidone therapyExtrapyramidal symptomsBlood assessmentMass indexPlacebo nonrespondersMovement ScaleLifetime diagnosisRisperidone for the Core Symptom Domains of Autism: Results From the Study by the Autism Network of the Research Units on Pediatric Psychopharmacology
McDougle CJ, Scahill L, Aman MG, McCracken JT, Tierney E, Davies M, Arnold LE, Posey DJ, Martin A, Ghuman JK, Shah B, Chuang SZ, Swiezy NB, Gonzalez NM, Hollway J, Koenig K, McGough JJ, Ritz L, Vitiello B. Risperidone for the Core Symptom Domains of Autism: Results From the Study by the Autism Network of the Research Units on Pediatric Psychopharmacology. American Journal Of Psychiatry 2005, 162: 1142-1148. PMID: 15930063, DOI: 10.1176/appi.ajp.162.6.1142.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAntipsychotic AgentsAutistic DisorderChildCommunication DisordersConduct DisorderDouble-Blind MethodFemaleHumansInterpersonal RelationsMalePersonality InventoryPlacebosPsychiatric Status Rating ScalesRisperidoneStereotyped BehaviorStereotypic Movement DisorderTreatment OutcomeConceptsYale-Brown Obsessive Compulsive ScaleChildren's Yale-Brown Obsessive Compulsive ScaleRitvo-Freeman Real Life Rating ScaleObsessive Compulsive ScaleBehavior domainsVineland Adaptive Behavior ScalesCompulsive ScaleCore symptom domainsAdaptive Behavior ScalesSensory-motor behaviorsSelf-injurious behaviorCommunicative impairmentsAutistic childrenSocial relatednessAutism NetworkRating ScaleCommunication impairmentsSevere tantrumsCore symptomsBehavior ScaleSocial interactionAutistic disorderAutismSymptom domainsLife Rating Scale
2002
Risperidone in Children with Autism and Serious Behavioral Problems
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. New England Journal Of Medicine 2002, 347: 314-321. PMID: 12151468, DOI: 10.1056/nejmoa013171.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAntipsychotic AgentsAutistic DisorderChildChild BehaviorChild, PreschoolDouble-Blind MethodFemaleHumansMaleRisperidoneTreatment OutcomeConceptsClinical Global Impression-ImprovementAtypical antipsychotic agentsPlacebo groupSelf-injurious behaviorRisperidone groupAntipsychotic agentsAutistic disorderIrritability scoresDouble-blind trialPrimary outcome measureTreatment of adultsTraditional antipsychotic medicationsPercent decreaseSerious behavioral disturbancesAberrant Behavior ChecklistRisperidone therapyTardive dyskinesiaAntipsychotic medicationAverage weight gainOutcome measuresPositive responsePostsynaptic dopamineSerotonin receptorsBehavioral disturbancesSevere tantrums
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