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 assignmentRisperidoneTrialsBlindnessParentsArmAutism
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
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