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A randomized double blind placebo controlled clinical trial of N-Acetylcysteine added to risperidone for treating autistic disorders . BACKGROUND This study examined the efficacy and safety of N-acetylcysteine ( NAC ) augmentation for treating irritability in children and adolescents with autism spectrum disorders ( ASD ) . METHOD Forty children and adolescents met diagnostic criteria for ASD according to DSM-IV . They were randomly allocated into one of the two groups of NAC ( 1200 mg/day ) +risperidone or placebo+risperidone . NAC and placebo were administered in the form of effervescent and in two divided doses for 8 weeks . Irritability subscale score of Aberrant Behavior Checklist ( ABC ) was considered as the main outcome measure . Adverse effects were also checked . RESULTS The mean score of irritability in the NAC+risperidone and placebo+risperidone groups at baseline was 13.2 ( 5.3 ) and 16.7 ( 7.8 ) , respectively . The scores after 8 weeks were 9.7 ( 4.1 ) and 15.1 ( 7.8 ) , respectively . Repeated measures of ANOVA showed that there was a significant difference between the two groups after 8 weeks . The most common adverse effects in the NAC+risperidone group were constipation ( 16.1 % ) , increased appetite ( 16.1 % ) , fatigue ( 12.9 % ) , nervousness ( 12.9 % ) , and daytime drowsiness ( 12.9 % ) . There was no fatal adverse effect . CONCLUSIONS Risperidone plus NAC more than risperidone plus placebo decreased irritability in children and adolescents with ASD . Meanwhile , it did not change the core symptoms of autism . Adverse effects were not common and NAC was generally tolerated well . TRIAL REGISTRATION This trial was registered at http : //www.irct.ir . The registration number of this trial was IRCT201106103930N6 .
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Intervention_Control
placebo
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Intervention_Pharmacological
N-Acetylcysteine
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Intervention_Pharmacological
risperidone
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Intervention_Pharmacological
N-acetylcysteine ( NAC )
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Outcome_Mental
Irritability subscale score of Aberrant Behavior Checklist
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Outcome_Adverse-effects
Adverse effects
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Outcome_Mental
mean score of irritability
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Outcome_Adverse-effects
constipation
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Outcome_Adverse-effects
increased appetite
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Outcome_Adverse-effects
fatigue
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Outcome_Adverse-effects
nervousness
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Outcome_Adverse-effects
daytime drowsiness
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Outcome_Adverse-effects
no fatal adverse effect
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Outcome_Mental
core symptoms of autism
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Participant_Condition
autistic
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Participant_Condition
autism
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Participant_Age
Forty children and adolescents
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Participant_Condition
ASD
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Participant_Condition
ASD