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document
Efficacy of Low-Dose Buspirone for Restricted and Repetitive Behavior in Young Children with Autism Spectrum Disorder : A Randomized Trial . OBJECTIVES To determine safety and efficacy of the 5HT1A serotonin partial agonist buspirone on core autism and associated features in children with autism spectrum disorder ( ASD ) . STUDY DESIGN Children 2-6 years of age with ASD ( N = 166 ) were randomized to receive placebo or 2.5 or 5.0 mg of buspirone twice daily . The primary objective was to evaluate the effects of 24 weeks of buspirone on the Autism Diagnostic Observation Schedule ( ADOS ) Composite Total Score . Secondary objectives included evaluating the effects of buspirone on social competence , repetitive behaviors , language , sensory dysfunction , and anxiety and to assess side effects . Positron emission tomography measures of tryptophan metabolism and blood serotonin concentrations were assessed as predictors of buspirone efficacy . RESULTS There was no difference in the ADOS Composite Total Score between baseline and 24 weeks among the 3 treatment groups ( P = .400 ) ; however , the ADOS Restricted and Repetitive Behavior score showed a time-by-treatment effect ( P = .006 ) ; the 2.5-mg buspirone group showed significant improvement ( P = .003 ) , whereas placebo and 5.0-mg buspirone groups showed no change . Children in the 2.5-mg buspirone group were more likely to improve if they had fewer foci of increased brain tryptophan metabolism on positron emission tomography ( P = .018 ) or if they showed normal levels of blood serotonin ( P = .044 ) . Adverse events did not differ significantly among treatment groups . CONCLUSIONS Treatment with 2.5 mg of buspirone in young children with ASD might be a useful adjunct therapy to target restrictive and repetitive behaviors in conjunction with behavioral interventions . TRIAL REGISTRATION ClinicalTrials.gov : NCT00873509 .
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Intervention_Pharmacological
Low-Dose Buspirone
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Intervention_Pharmacological
5HT1A serotonin partial agonist buspirone
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Intervention_Control
placebo
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Intervention_Pharmacological
buspirone
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Intervention_Pharmacological
buspirone
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Intervention_Pharmacological
buspirone
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Intervention_Pharmacological
buspirone
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Intervention_Pharmacological
buspirone
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Intervention_Control
placebo
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Intervention_Pharmacological
buspirone
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Intervention_Pharmacological
buspirone
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Intervention_Pharmacological
buspirone
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Outcome_Physical
Autism Diagnostic Observation Schedule ( ADOS ) Composite Total Score
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Outcome_Physical
social competence
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Outcome_Physical
repetitive behaviors
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Outcome_Physical
language
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Outcome_Physical
sensory dysfunction
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Outcome_Physical
anxiety
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Outcome_Adverse-effects
side effects
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Outcome_Physical
Positron emission tomography measures of tryptophan metabolism and blood serotonin concentrations
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Outcome_Physical
ADOS Composite Total Score
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Outcome_Physical
ADOS Restricted and Repetitive Behavior score
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Participant_Age
Young Children
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Participant_Condition
Autism Spectrum Disorder
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Participant_Age
children
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Participant_Condition
autism spectrum disorder ( ASD )
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Participant_Age
Children 2-6 years of age
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Participant_Condition
ASD
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Participant_Sample-size
166
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Participant_Age
young children
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Participant_Condition
ASD