24932
document
Acute and long-term safety and tolerability of risperidone in children with autism . Treatment-emergent adverse events ( AEs ) were monitored during an 8-week , double-blind , placebo-controlled trial of risperidone ( 0.5-3.5 mg/day ) in 101 children and adolescents with a lifetime diagnosis of autistic disorder . In addition , 37 placebo nonresponders received open-label risperidone for another 8 weeks . Of all the risperidone responders ( n=65 ) , 63 entered an open extension of another 16 weeks ( 6 months total risperidone exposure ) , and 32 of them were rerandomized to either continued risperidone therapy ( n=16 ) or gradual replacement with placebo ( n=16 ) over 8 weeks . We collected the following measures of safety and tolerability : ( 1 ) laboratory blood assessments ( CBC with differential , electrolytes , and liver function tests ) and urinalyses , ( 2 ) vital signs , ( 3 ) Side Effects Review of AEs thought to be associated with risperidone , ( 4 ) sleep records , ( 5 ) Simpson Angus Neurological Rating Scale ( SARS ) , ( 6 ) Abnormal Involuntary Movement Scale ( AIMS ) , and ( 7 ) height and weight . No clinically significant changes were found on the lab tests . During the 8-week acute trial , the most common AEs on the Side Effects Review , scored as moderate or higher , were as follows ( placebo and risperidone , respectively ) : Somnolence ( 12 % and 37 % ) , enuresis ( 29 % and 33 % ) , excessive appetite ( 10 % and 33 % ) , rhinitis ( 8 % and 16 % ) , difficulty waking ( 8 % and 12 % ) , and constipation ( 12 % and 10 % ) . " Difficulty falling asleep " and anxiety actually favored the risperidone condition at statistically significant levels . The same AEs tended to recur through 6 months of treatment , although often at reduced levels . Using Centers for Disease Control ( CDC ) standardized scores , both weight and body mass index ( BMI ) increased with risperidone during the acute trial ( 0.5 and 0.6 SDs , respectively , for risperidone ; 0.0 and 0.1 SDs , respectively , for placebo ) and into open-label extension ( 0.19 and 0.16 SDs , respectively ) , although the amount of gain decelerated with time . Extrapyramidal symptoms , as assessed by the SARS , were no more common for drug than placebo , although drooling was reported more often in the risperidone group . There were no differences between groups on the AIMS . Two subjects had seizures ( one taking placebo ) , but these were considered unrelated to active drug . Most AEs were mild to moderate and failed to interfere with therapeutic changes ; there were no unanticipated AEs . The side effects of most concern were somnolence and weight gain .
24933
Intervention_Pharmacological
risperidone
24934
Intervention_Control
placebo-controlled
24935
Intervention_Pharmacological
risperidone
24936
Intervention_Pharmacological
risperidone
24937
Intervention_Pharmacological
risperidone
24938
Intervention_Pharmacological
risperidone
24939
Intervention_Pharmacological
risperidone
24940
Intervention_Pharmacological
risperidone
24941
Intervention_Pharmacological
risperidone ;
24942
Intervention_Pharmacological
risperidone
24943
Outcome_Other
Acute and long-term safety and tolerability
24944
Outcome_Adverse-effects
adverse events
24945
Outcome_Other
safety and tolerability
24946
Outcome_Other
laboratory
24947
Outcome_Physical
blood assessments
24948
Outcome_Other
( CBC with differential , electrolytes , and liver function tests ) and urinalyses
24949
Outcome_Physical
vital signs
24950
Outcome_Adverse-effects
Side Effects Review of AEs
24951
Outcome_Physical
sleep records
24952
Outcome_Physical
Simpson Angus Neurological Rating Scale ( SARS )
24953
Outcome_Physical
Abnormal Involuntary Movement Scale ( AIMS )
24954
Outcome_Physical
height and weight
24955
Outcome_Adverse-effects
Somnolence
24956
Outcome_Adverse-effects
enuresis
24957
Outcome_Adverse-effects
excessive appetite
24958
Outcome_Adverse-effects
rhinitis
24959
Outcome_Adverse-effects
difficulty waking
24960
Outcome_Adverse-effects
constipation
24961
Outcome_Mental
Difficulty falling asleep " and anxiety
24962
Outcome_Adverse-effects
AEs
24963
Outcome_Physical
weight and body mass index ( BMI )
24964
Outcome_Physical
Extrapyramidal symptoms
24965
Outcome_Physical
seizures
24966
Outcome_Adverse-effects
somnolence
24967
Outcome_Adverse-effects
weight gain
24968
Participant_Age
children
24969
Participant_Condition
autism
24970
Participant_Age
101 children
24971
Participant_Age
adolescents
24972
Participant_Condition
autistic disorder