42085
document
A placebo-controlled , fixed-dose study of aripiprazole in children and adolescents with irritability associated with autistic disorder . OBJECTIVE To evaluate the short-term efficacy and safety of aripiprazole in the treatment of irritability in children and adolescents with autistic disorder . METHOD Two hundred eighteen children and adolescents ( aged 6-17 years ) with a diagnosis of autistic disorder , and with behaviors such as tantrums , aggression , self-injurious behavior , or a combination of these symptoms , were randomized 1:1:1:1 to aripiprazole ( 5 , 10 , or 15 mg/day ) or placebo in this 8-week double-blind , randomized , placebo-controlled , parallel-group study . Efficacy was evaluated using the caregiver-rated Aberrant Behavior Checklist Irritability subscale ( primary efficacy measure ) and the clinician-rated Clinical Global Impressions-Improvement score . Safety and tolerability were also assessed . RESULTS At week 8 , all aripiprazole doses produced significantly greater improvement than placebo in mean Aberrant Behavior Checklist Irritability subscale scores ( 5 mg/day , -12.4 ; 10 mg/day , -13.2 ; 15 mg/day , -14.4 ; versus placebo , -8.4 ; all p < .05 ) . All aripiprazole doses demonstrated significantly greater improvements in mean Clinical Global Impressions-Improvement score than placebo at week 8 . Discontinuation rates due to adverse events were as follows : placebo 7.7 % , aripiprazole 5 mg/day 9.4 % , 10 mg/day 13.6 % , and 15 mg/day 7.4 % . The most common adverse event leading to discontinuation was sedation . There were two serious adverse events : presyncope ( 5 mg/day ) and aggression ( 10 mg/day ) . At week 8 , mean weight change ( last observation carried forward ) was as follows : placebo +0.3 kg , aripiprazole 5 mg/day +1.3 kg , 10 mg/day +1.3 kg , and 15 mg/day +1.5 kg ; all p < .05 versus placebo . CONCLUSIONS Aripiprazole was efficacious and generally safe and well tolerated in the treatment of children and adolescents with irritability associated with autistic disorder .
42086
Intervention_Control
placebo-controlled
42087
Intervention_Pharmacological
aripiprazole
42088
Intervention_Pharmacological
aripiprazole
42089
Intervention_Pharmacological
aripiprazole
42090
Intervention_Pharmacological
aripiprazole
42091
Intervention_Pharmacological
aripiprazole
42092
Intervention_Control
placebo
42093
Intervention_Pharmacological
aripiprazole
42094
Intervention_Control
placebo
42095
Intervention_Pharmacological
Aripiprazole
42096
Outcome_Other
efficacy
42097
Outcome_Other
safety
42098
Outcome_Other
Efficacy
42099
Outcome_Mental
Aberrant Behavior Checklist Irritability subscale ( primary efficacy measure )
42100
Outcome_Mental
clinician-rated Clinical Global Impressions-Improvement score
42101
Outcome_Other
Safety and tolerability
42102
Outcome_Other
improvement
42103
Outcome_Mental
Aberrant Behavior Checklist Irritability subscale scores
42104
Outcome_Mental
improvements in mean Clinical Global Impressions-Improvement score
42105
Outcome_Adverse-effects
adverse events
42106
Outcome_Adverse-effects
adverse event
42107
Outcome_Adverse-effects
serious adverse events
42108
Outcome_Adverse-effects
presyncope
42109
Outcome_Adverse-effects
aggression
42110
Outcome_Physical
weight change
42111
Outcome_Other
efficacious
42112
Outcome_Other
safe
42113
Outcome_Other
well tolerated
42114
Participant_Age
children
42115
Participant_Age
adolescents
42116
Participant_Condition
irritability
42117
Participant_Condition
autistic disorder
42118
Participant_Age
children
42119
Participant_Age
adolescents
42120
Participant_Condition
autistic disorder
42121
Participant_Sample-size
Two hundred eighteen
42122
Participant_Age
children
42123
Participant_Age
adolescents
42124
Participant_Age
6-17 years
42125
Participant_Condition
autistic disorder
42126
Participant_Condition
tantrums
42127
Participant_Condition
aggression , self-injurious behavior ,
42128
Participant_Age
children
42129
Participant_Age
adolescents
42130
Participant_Condition
irritability
42131
Participant_Condition
autistic disorder .