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