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A randomized double-blind placebo-controlled clinical trial of adjuvant buspirone for irritability in autism . BACKGROUND The brain serotonin level is decreased in individuals with autism . Buspirone is a 5-HT ( 1A ) receptor agonist with antiaggressive effects increasing prosocial behaviors . METHODS We conducted an 8-week randomized double-blind placebo-controlled clinical trial . Participants included 40 outpatient children and adolescents with autism . The patients took buspirone plus risperidone or risperidone plus placebo during 8 weeks . The patients were assessed at baseline , week 4 , and week 8 using the Aberrant Behavior Checklist-Community Rating Scale . RESULTS Eighteen patients in the placebo group and 16 patients in the buspirone group completed this trial . The mean dose of buspirone was 6.7 ( SD 2.7 ) mg/day . Irritability subscale score significantly decreased during this trial in both groups ( buspirone group : declined from 25.7 [ SD 5.7 ] to 16.3 [ SD 8.5 ] ; placebo group : declined from 24.7 [ SD 7.6 ] to 18.2 [ SD 7.7 ] ) . The Cohen d effect size was .45 . Thirteen ( 81.2 % ) of 16 patients in the buspirone group and 7 ( 38.9 % ) of 18 patients in the placebo group showed a ≥30 % decline in irritability score . The relative risk for treatment was 2.1 . There were no serious adverse effects . The most common adverse effects in the buspirone group were increased appetite , drowsiness , and fatigue . CONCLUSION This clinical trial supports that low dose buspirone plus risperidone is more effective than risperidone plus placebo for treating irritability in individuals with autism .
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Intervention_Pharmacological
buspirone
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
buspirone plus risperidone
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Intervention_Pharmacological
risperidone
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Intervention_Control
plus placebo
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Outcome_Physical
irritability
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Outcome_Other
Irritability subscale score
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Outcome_Other
in irritability score
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Outcome_Adverse-effects
The relative risk
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Outcome_Adverse-effects
no serious adverse effects
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Outcome_Physical
were increased appetite
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Outcome_Physical
drowsiness
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Outcome_Physical
fatigue
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Outcome_Physical
treating irritability
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Participant_Condition
irritability in autism
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Participant_Sample-size
40 outpatient
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Participant_Age
children
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Participant_Age
adolescents
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Participant_Sample-size
Eighteen patients
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Participant_Sample-size
16 patients
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Participant_Condition
in individuals with autism