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document
N-acetylcysteine as an adjunctive therapy to risperidone for treatment of irritability in autism : a randomized , double-blind , placebo-controlled clinical trial of efficacy and safety . OBJECTIVES According to the proposed interference of N-acetylcysteine ( NAC ) with pathophysiologic processes of autistic disorders ( ADs ) , we aimed to assess the effectiveness and safety of NAC as an adjunct to risperidone in the treatment of ADs in a randomized , double-blind , clinical trial . METHODS The participants were referred outpatients between 4 and 12 years of age with the diagnosis of ADs and a score of more than 12 on Aberrant Behavior Checklist-Community ( ABC-C ) Irritability subscale score . The participants were randomized into 2 groups . One group received risperidone plus NAC , and the other group received risperidone plus placebo . The dose of risperidone was titrated between 1 and 2.0 mg/d , and the dose of NAC was 600 to 900 mg/d . The main outcome was mean decrease in the ABC-C irritability subscale score from baseline at 5 and 10 weeks . Changes in other subscales were considered as secondary outcome measures . RESULTS Forty patients completed the 10-week trial . Baseline characteristics including age , sex and body weight , as well as baseline scores in 5 subscales did not demonstrate statistically significant difference between the 2 groups . Repeated-measures analysis showed significant effect for time × treatment interaction in irritability ( P = 0.01 ) and hyperactivity/noncompliance ( P = 0.02 ) subscales . By week 10 , the NAC group showed significantly more reduction in irritability ( P = 0.02 ) and hyperactivity/noncompliance ( P = 0.01 ) subscales scores . CONCLUSIONS N-acetylcysteine can be considered as an adjuvant therapy for ADs with beneficial therapeutic outcomes .
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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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Intervention_Pharmacological
NAC
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Intervention_Pharmacological
risperidone
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Intervention_Pharmacological
risperidone plus NAC
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Intervention_Control
risperidone plus placebo
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Intervention_Pharmacological
risperidone
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Intervention_Pharmacological
NAC
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Outcome_Other
the effectiveness and safety
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Outcome_Mental
Aberrant Behavior Checklist-Community ( ABC-C ) Irritability subscale score .
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Outcome_Mental
mean decrease in the ABC-C irritability subscale score
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Outcome_Other
Changes in other subscales
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Outcome_Other
baseline scores
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Outcome_Other
subscales
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Outcome_Other
effect
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Participant_Condition
in autism
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Participant_Age
participants were referred outpatients between 4 and 12 years of age
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Participant_Condition
the diagnosis of ADs
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Participant_Condition
a score of more than 12 on Aberrant Behavior Checklist-Community ( ABC-C ) Irritability subscale score
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Participant_Sample-size
Forty
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Participant_Sample-size
10-week