passages: 2901
passages: document
passages: An open-label extension study of the safety and efficacy of risperidone in children and adolescents with autistic disorder . OBJECTIVE The purpose of this study was to evaluate the long-term safety and efficacy of risperidone in treating irritability and related behaviors in children and adolescents with autistic disorders . METHODS In this 6 month ( 26 week ) open-label extension ( OLE ) study , patients ( 5-17 years of age , who completed the previous fixed-dose , 6 week , double-blind [ DB ] phase ) were flexibly dosed with risperidone based on body weight . The maximum allowed dose was 1.25 mg/day for those weighing 20 to < 45 kg , and 1.75 mg/day for those weighing ≥ 45 kg . The study primarily assessed risperidone 's safety ; efficacy was assessed as a secondary end-point . RESULTS Fifty-six ( 71 % ) out of 79 enrolled patients completed the OLE ; the most common discontinuations were for insufficient response ( 7 [ 9 % ] ) or adverse events ( AE ) ( 5 [ 6 % ] ) . The most common ( ≥ 5 % frequency in the total group ) AEs were increased appetite ( 11 % [ n=9 ] ) ; increased weight and vomiting ( 9 % [ n=7 ] each ) ; sedation , pyrexia , and upper respiratory tract infection ( 8 % [ n=6 ] each ) ; nasopharyngitis ( 6 % [ n=5 ] ) ; and somnolence and fatigue ( 5 % [ n=4 ] each ) . Extrapyramidal AEs were reported in 6 ( 8 % ) patients . Increase in mean weight ( 11-15 % ) and body mass index ( 5-10 % ) occurred ; one patient discontinued because of weight increase . One potentially prolactin-related AE ( irregular menstruation ) was reported . The risperidone high-dose group had the greatest mean improvement in sleep visual analog scale ( 24.6 ) . All groups showed additional improvement in efficacy scale scores during the OLE . CONCLUSIONS During this OLE , safety findings with risperidone treatment ( maximum weight-based dose of 1.25 mg/day or 1.75 mg/day ) were consistent with those observed in the DB phase , and with the current safety information for risperidone in autistic , psychiatric , and behavioral disorders . Patients experienced some additional improvement in irritability and related behaviors . CLINICAL TRIALS REGISTRY This phase-4 study is registered at ClinicalTrials.gov ( NCT00576732 ) .
entities: 2902
entities: Intervention_Pharmacological
entities: risperidone
entities: 2903
entities: Intervention_Pharmacological
entities: risperidone
entities: 2904
entities: Intervention_Pharmacological
entities: risperidone
entities: 2905
entities: Intervention_Pharmacological
entities: risperidone
entities: 2906
entities: Intervention_Pharmacological
entities: risperidone
entities: 2907
entities: Outcome_Other
entities: safety
entities: 2908
entities: Outcome_Other
entities: efficacy
entities: 2909
entities: Outcome_Adverse-effects
entities: adverse events
entities: 2910
entities: Outcome_Adverse-effects
entities: increased appetite
entities: 2911
entities: Outcome_Adverse-effects
entities: increased weight
entities: 2912
entities: Outcome_Adverse-effects
entities: vomiting
entities: 2913
entities: Outcome_Adverse-effects
entities: sedation
entities: 2914
entities: Outcome_Adverse-effects
entities: pyrexia
entities: 2915
entities: Outcome_Adverse-effects
entities: upper respiratory tract infection
entities: 2916
entities: Outcome_Adverse-effects
entities: nasopharyngitis
entities: 2917
entities: Outcome_Adverse-effects
entities: somnolence
entities: 2918
entities: Outcome_Adverse-effects
entities: fatigue
entities: 2919
entities: Outcome_Adverse-effects
entities: Extrapyramidal
entities: 2920
entities: Outcome_Adverse-effects
entities: weight
entities: 2921
entities: Outcome_Adverse-effects
entities: prolactin-related AE
entities: 2922
entities: Outcome_Adverse-effects
entities: irregular menstruation
entities: 2923
entities: Outcome_Physical
entities: sleep visual analog scale
entities: 2924
entities: Outcome_Other
entities: efficacy
entities: 2925
entities: Participant_Age
entities: children and adolescents
entities: 2926
entities: Participant_Condition
entities: autistic disorder
entities: 2927
entities: Participant_Age
entities: children and adolescents
entities: 2928
entities: Participant_Condition
entities: autistic disorders
entities: 2929
entities: Participant_Age
entities: 5-17 years of age