53795
document
A randomized controlled pilot trial of oral N-acetylcysteine in children with autism . BACKGROUND An imbalance in the excitatory/inhibitory systems with abnormalities in the glutamatergic pathways has been implicated in the pathophysiology of autism . Furthermore , chronic redox imbalance was also recently linked to this disorder . The goal of this pilot study was to assess the feasibility of using oral N-acetylcysteine ( NAC ) , a glutamatergic modulator and an antioxidant , in the treatment of behavioral disturbance in children with autism . METHODS This was a 12-week , double-blind , randomized , placebo-controlled study of NAC in children with autistic disorder . Subjects randomized to NAC were initiated at 900 mg daily for 4 weeks , then 900 mg twice daily for 4 weeks and 900 mg three times daily for 4 weeks . The primary behavioral measure ( Aberrant Behavior Checklist [ ABC ] irritability subscale ) and safety measures were performed at baseline and 4 , 8 , and 12 weeks . Secondary measures included the ABC stereotypy subscale , Repetitive Behavior Scale-Revised , and Social Responsiveness Scale . RESULTS Thirty-three subjects ( 31 male subjects , 2 female subjects ; aged 3.2-10.7 years ) were randomized in the study . Follow-up data was available on 14 subjects in the NAC group and 15 in the placebo group . Oral NAC was well tolerated with limited side effects . Compared with placebo , NAC resulted in significant improvements on ABC irritability subscale ( F = 6.80 ; p < .001 ; d = .96 ) . CONCLUSIONS Data from this pilot investigation support the potential usefulness of NAC for treating irritability in children with autistic disorder . Large randomized controlled investigations are warranted .
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Intervention_Pharmacological
N-acetylcysteine
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Intervention_Pharmacological
oral N-acetylcysteine ( NAC )
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
NAC
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Intervention_Pharmacological
NAC
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Intervention_Control
placebo
53802
Intervention_Pharmacological
NAC
53803
Intervention_Control
placebo
53804
Intervention_Pharmacological
NAC
53805
Intervention_Pharmacological
NAC
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Outcome_Mental
Aberrant Behavior Checklist [ ABC ] irritability subscale
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Outcome_Mental
ABC stereotypy subscale , Repetitive Behavior Scale-Revised , and Social Responsiveness Scale
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Outcome_Other
tolerated
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Outcome_Mental
ABC irritability subscale
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Participant_Age
children
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Participant_Condition
autism
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Participant_Age
children
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Participant_Condition
autism
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Participant_Age
children
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Participant_Condition
autistic disorder
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Participant_Sample-size
Thirty-three
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Participant_Sample-size
31
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Participant_Sex
male
53819
Participant_Sample-size
2
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Participant_Sex
female
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Participant_Age
3.2-10.7 years
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Participant_Sample-size
14
53823
Participant_Sample-size
15
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Participant_Age
children
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Participant_Condition
autistic disorder