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document
Risperidone in children with autism and serious behavioral problems . BACKGROUND Atypical antipsychotic agents , which block postsynaptic dopamine and serotonin receptors , have advantages over traditional antipsychotic medications in the treatment of adults with schizophrenia and may be beneficial in children with autistic disorder who have serious behavioral disturbances . However , data on the safety and efficacy of atypical antipsychotic agents in children are limited . METHODS We conducted a multisite , randomized , double-blind trial of risperidone as compared with placebo for the treatment of autistic disorder accompanied by severe tantrums , aggression , or self-injurious behavior in children 5 to 17 years old . The primary outcome measures were the score on the Irritability subscale of the Aberrant Behavior Checklist and the rating on the Clinical Global Impressions - Improvement ( CGI-I ) scale at eight weeks . RESULTS A total of 101 children ( 82 boys and 19 girls ; mean [ +/-SD ] age , 8.8+/-2.7 years ) were randomly assigned to receive risperidone ( 49 children ) or placebo ( 52 ) . Treatment with risperidone for eight weeks ( dose range , 0.5 to 3.5 mg per day ) resulted in a 56.9 percent reduction in the Irritability score , as compared with a 14.1 percent decrease in the placebo group ( P < 0.001 ) . The rate of a positive response , defined as at least a 25 percent decrease in the Irritability score and a rating of much improved or very much improved on the CGI-I scale , was 69 percent in the risperidone group ( 34 of 49 children had a positive response ) and 12 percent in the placebo group ( 6 of 52 , P < 0.001 ) . Risperidone therapy was associated with an average weight gain of 2.7+/-2.9 kg , as compared with 0.8+/-2.2 kg with placebo ( P < 0.001 ) . Increased appetite , fatigue , drowsiness , dizziness , and drooling were more common in the risperidone group than in the placebo group ( P < 0.05 for each comparison ) . In two thirds of the children with a positive response to risperidone at eight weeks ( 23 of 34 ) , the benefit was maintained at six months . CONCLUSIONS Risperidone was effective and well tolerated for the treatment of tantrums , aggression , or self-injurious behavior in children with autistic disorder . The short period of this trial limits inferences about adverse effects such as tardive dyskinesia .
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Intervention_Pharmacological
Risperidone
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Intervention_Pharmacological
atypical antipsychotic
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Intervention_Pharmacological
risperidone
10053
Intervention_Control
placebo
10054
Intervention_Pharmacological
risperidone
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Intervention_Control
placebo
10056
Intervention_Pharmacological
risperidone
10057
Intervention_Control
placebo
10058
Intervention_Pharmacological
risperidone
10059
Intervention_Control
placebo
10060
Intervention_Pharmacological
Risperidone
10061
Intervention_Control
placebo
10062
Intervention_Pharmacological
risperidone
10063
Intervention_Pharmacological
Risperidone
10064
Outcome_Mental
Irritability score
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Outcome_Mental
Irritability score
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Outcome_Mental
CGI-I scale
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Outcome_Physical
average weight gain
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Outcome_Physical
appetite ,
10069
Outcome_Adverse-effects
fatigue
10070
Outcome_Physical
,
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Outcome_Adverse-effects
drowsiness
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Outcome_Physical
,
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Outcome_Adverse-effects
dizziness
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Outcome_Physical
, and
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Outcome_Adverse-effects
drooling
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Participant_Age
children
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Participant_Condition
autism
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Participant_Condition
behavioral problems .
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Participant_Condition
autistic disorder
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Participant_Age
children
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Participant_Sample-size
101
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Participant_Sample-size
82
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Participant_Sample-size
19
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Participant_Sample-size
49
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Participant_Age
children
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Participant_Condition
autistic disorder