2009
Medication and Parent Training in Children With Pervasive Developmental Disorders and Serious Behavior Problems: Results From a Randomized Clinical Trial
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, Network F. Medication and Parent Training in Children With Pervasive Developmental Disorders and Serious Behavior Problems: Results From a Randomized Clinical Trial. Journal Of The American Academy Of Child & Adolescent Psychiatry 2009, 48: 1143-1154. PMID: 19858761, PMCID: PMC3142923, DOI: 10.1097/chi.0b013e3181bfd669.Peer-Reviewed Original ResearchConceptsPervasive developmental disorderClinical trialsClinical Global Impressions-Improvement scoreAberrant Behavior Checklist IrritabilityParallel-group clinical trialParent trainingBehavioral problemsDevelopmental disordersRisperidone doseRisperidone monotherapyHyperactivity/noncompliance subscaleSevere behavioral problemsCOMB groupPT sessionsQuestionnaire scoresHSQ scoresMedicationsGreater reductionChildrenPrimary measureRisperidoneSignificant reductionStereotypic behaviorScoresDose
2008
Cognitive Effects of Risperidone in Children with Autism and Irritable Behavior
Aman MG, Hollway JA, McDougle CJ, Scahill L, Tierney E, McCracken JT, Arnold LE, Vitiello B, Ritz L, Gavaletz A, Cronin P, Swiezy N, Wheeler C, Koenig K, Ghuman JK, Posey DJ. Cognitive Effects of Risperidone in Children with Autism and Irritable Behavior. Journal Of Child And Adolescent Psychopharmacology 2008, 18: 227-236. PMID: 18582177, PMCID: PMC2935828, DOI: 10.1089/cap.2007.0133.Peer-Reviewed Original ResearchConceptsSevere behavioral disturbancesVerbal learning taskSpatial memory taskIrritable behaviorPurdue pegboard taskDouble-blind placebo-controlled parallel group designBehavioral disturbancesPlacebo-controlled parallel-group designMemory taskCognitive processesVerbal learningCognitive tasksMental ageSustained attentionHand-eye coordinationCognitive effectsCognitive performanceCancellation taskLearning taskSpatial memoryCognitive partDependent measuresPegboard taskAutismClassroom tasks
2006
Children's Yale-Brown Obsessive Compulsive Scale Modified for Pervasive Developmental Disorders
SCAHILL L, MCDOUGLE CJ, WILLIAMS SK, DIMITROPOULOS A, AMAN MG, MCCRACKEN JT, TIERNEY E, ARNOLD LE, CRONIN P, GRADOS M, GHUMAN J, KOENIG K, LAM KS, MCGOUGH J, POSEY DJ, RITZ L, SWIEZY NB, VITIELLO B. Children's Yale-Brown Obsessive Compulsive Scale Modified for Pervasive Developmental Disorders. Journal Of The American Academy Of Child & Adolescent Psychiatry 2006, 45: 1114-1123. PMID: 16926619, DOI: 10.1097/01.chi.0000220854.79144.e7.Peer-Reviewed Original ResearchConceptsChildren's Yale-Brown Obsessive Compulsive ScalePervasive developmental disorderYale-Brown Obsessive Compulsive ScaleRepetitive behaviorsYale-Brown Obsessive Compulsive Scale ModifiedDevelopmental disordersPediatric Psychopharmacology Autism NetworkLower adaptive functioningInternal consistencyMeasures of irritabilityMedication-free childrenExcellent internal consistencyObsessive Compulsive Scale
2005
Assessment of the Integrity of Study Blindness in a Pediatric Clinical Trial of Risperidone
Vitiello B, Davies M, Arnold L, McDougle C, Aman M, McCracken J, Scahill L, Tierney E, Posey D, Swiezy N, Koenig K. Assessment of the Integrity of Study Blindness in a Pediatric Clinical Trial of Risperidone. Journal Of Clinical Psychopharmacology 2005, 25: 565-569. PMID: 16282839, DOI: 10.1097/01.jcp.0000185426.08268.92.Peer-Reviewed Original ResearchConceptsPlacebo treatment armsClinical evaluatorsAdverse eventsClinical trialsTreatment assignmentTreatment armsActual treatment assignmentPlacebo-controlled trialPediatric clinical trialsAdverse event dataLack of improvementActive treatmentOutcome dataPediatric psychopharmacologyIndividual treatment assignmentRisperidoneTrialsBlindnessParentsArmAutismAcute 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 diagnosis
2003
Parent-Defined Target Symptoms Respond to Risperidone in RUPP Autism Study: Customer Approach to Clinical Trials
ARNOLD L, VITIELLO B, MCDOUGLE C, SCAHILL L, SHAH B, GONZALEZ N, CHUANG S, DAVIES M, HOLLWAY J, AMAN M, CRONIN P, KOENIG K, KOHN A, MCMAHON D, TIERNEY E. Parent-Defined Target Symptoms Respond to Risperidone in RUPP Autism Study: Customer Approach to Clinical Trials. Journal Of The American Academy Of Child & Adolescent Psychiatry 2003, 42: 1443-1450. PMID: 14627879, DOI: 10.1097/00004583-200312000-00011.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAffectAggressionAutistic DisorderChildClinical Trials as TopicDopamine AntagonistsDouble-Blind MethodEndpoint DeterminationFemaleHumansMaleObserver VariationParent-Child RelationsPlacebosResearch DesignRisperidoneSeverity of Illness IndexStereotyped BehaviorTreatment OutcomeConceptsAberrant Behavior Checklist-Irritability subscaleClinical trialsIrritability subscaleClinical Global Impression-ImprovementDouble-blind trialPediatric Psychopharmacology Autism NetworkChief complaintCommon symptomsTarget symptomsEfficacy assessmentIrritable behaviorSymptom categoriesRisperidoneChange scoresSymptomsEffect size dInterrater reliabilityTrialsPlaceboTreatment effectsClinical applicationPrimary measureConsumer-friendly wayWeeksAutism Network
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