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
2004
Weight and Leptin Changes Among Risperidone-Treated Youths With Autism: 6-Month Prospective Data
Martin A, Scahill L, Anderson GM, Aman M, Arnold LE, McCracken J, McDougle CJ, Tierney E, Chuang S, Vitiello B. Weight and Leptin Changes Among Risperidone-Treated Youths With Autism: 6-Month Prospective Data. American Journal Of Psychiatry 2004, 161: 1125-1127. PMID: 15169706, DOI: 10.1176/appi.ajp.161.6.1125.Peer-Reviewed Original Research
2003
DRD4 exon III polymorphism and response to risperidone in Israeli adolescents with schizophrenia: a pilot pharmacogenetic study
Zalsman G, Frisch A, Lev-Ran S, Martin A, Michaelovsky E, Bensason D, Gothelf D, Nahshoni E, Tyano S, Weizman A. DRD4 exon III polymorphism and response to risperidone in Israeli adolescents with schizophrenia: a pilot pharmacogenetic study. European Neuropsychopharmacology 2003, 13: 183-185. PMID: 12729944, DOI: 10.1016/s0924-977x(03)00006-3.Peer-Reviewed Original ResearchConceptsBrief Psychiatric Rating ScalePossible associationAdolescent schizophrenia patientsFirst-episode schizophreniaPsychiatric Rating ScaleHigh response rateClinical responseRepeat alleleSchizophrenia patientsResponse rateSignificant associationPharmacogenetic studiesRisperidoneAdolescent inpatientsRating ScaleSchizophreniaAssociationDRD4 genotypeDRD4 geneResponseIsraeli adolescentsLarge groupPolymorphismDRD4 exon III polymorphismPatients
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 ResearchConceptsClinical 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 tantrumsTriglyceride, cholesterol and weight changes among risperidone-treated youths
Martin A, L'Ecuyer S. Triglyceride, cholesterol and weight changes among risperidone-treated youths. European Child & Adolescent Psychiatry 2002, 11: 129-133. PMID: 12369772, DOI: 10.1007/s00787-002-0255-5.Peer-Reviewed Original ResearchConceptsRisperidone-treated youthsMean ageWeight gainRetrospective chart reviewWeight changeRegular laboratory monitoringAtypical antipsychotic useSignificant weight gainSample mean ageChart reviewRisperidone doseAntipsychotic useSerum triglyceridesLaboratory monitoringTriglyceride levelsCholesterol levelsLipid dysregulationAdolescent inpatientsTriglyceridesPreliminary reportMeasures analysisSuch associationsCholesterolSignificant changesAverage length
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
Assessment in Multisite Randomized Clinical Trials of Patients with Autistic Disorder: The Autism RUPP Network
Arnold L, Aman M, Martin A, Collier-Crespin A, Vitiello B, Tierney E, Asarnow R, Bell-Bradshaw F, Freeman B, Gates-Ulanet P, Klin A, McCracken J, McDougle C, McGough J, Posey D, Scahill L, Swiezy N, Ritz L, Vokmar F. Assessment in Multisite Randomized Clinical Trials of Patients with Autistic Disorder: The Autism RUPP Network. Journal Of Autism And Developmental Disorders 2000, 30: 99-111. PMID: 10832774, DOI: 10.1023/a:1005451304303.Peer-Reviewed Original ResearchConceptsAutism Diagnostic InterviewChildren/adolescentsAutistic disorders symptomsNeuropsychological testsDisorder symptomsLower functioningAutistic disorderCore featuresTest developersDiagnostic InterviewProblem presentationPediatric psychopharmacologyAutismIndividual changesTreatment respondersTarget symptomsSecondary symptomsCommunication problemsMethodological challengesAssessment strategiesSubject heterogeneityIQPharmacological treatmentDisordersClinical Global ImpressionRisperidone-Associated Weight Gain in Children and Adolescents: A Retrospective Chart Review
Martin A, Landau J, Leebens P, Ulizio K, Cicchetti D, Scahill L, Leckman JF. Risperidone-Associated Weight Gain in Children and Adolescents: A Retrospective Chart Review. Journal Of Child And Adolescent Psychopharmacology 2000, 10: 259-268. PMID: 11191686, DOI: 10.1089/cap.2000.10.259.Peer-Reviewed Original ResearchConceptsBody mass indexSignificant weight gainBaseline weightRisperidone useWeight gainStandardized z-scoresZ-scoreConcomitant medication useRisperidone-treated subjectsWeight changeRetrospective chart reviewSmall case seriesPsychiatric inpatient populationProportion of subjectsSubstantial weight gainRisperidone dosageNeuroleptic exposureChart reviewMedication useMonths of observationCase seriesMass indexInpatient populationWeight increaseTanner stagingResearch 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