Evidence map›Paper›PMID 22342106›Full record

Trial reportBiological psychiatry2012

A randomized controlled pilot trial of oral N-acetylcysteine in children with autism.

Antonio Y Hardan, Lawrence K Fung, Robin A Libove, Tetyana V Obukhanych, Surekha Nair, Leonore A Herzenberg, Thomas W Frazier, Rabindra Tirouvanziam

6 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Biological psychiatry, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 113 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
113citing papers in PubMed, 8 pooled it
12.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00627705 phase2completednot on this map

Double-blind , Randomized, Placebo Controlled Study of N-Acetyl Cysteine in Autism.

TypeinterventionalSponsorStanford UniversityRan2008 to 2010Enrolled43ConditionsAutistic DisorderArmsN-Acetyl Cysteine, Placebo - sugar pill
NCT03195465 naterminatednot on this mapstarted 2017, after this paper: background citation

The Effect of High Antioxidant Cacao on Behaviors in Children With Autism Spectrum Disorder

TypeinterventionalSponsorLoma Linda UniversityRan2017 to 2018Enrolled16ConditionsAutism Spectrum DisorderArmsDark Chocolate
NCT04381897 phase2not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Use of N-Acetylcysteine (NAC) in the Treatment of Repetitive Behaviors (RB) and Self-Injurious Behaviors (SIB) in Cornelia de Lange Syndrome: A Randomized Double-Blind Placebo-Controlled Pilot Study

TypeinterventionalSponsorJohns Hopkins UniversityRan2026 to 2027Enrolled10ConditionsCornelia de Lange SyndromeArmsN-acetyl cysteine, Placebo
NCT04481035 phase2completednot on this mapstarted 2019, after this paper: background citation

Antioxidant Therapy With N-acetylcysteine for Learning and Motor Behavior in Children With Neurofibromatosis Type 1

TypeinterventionalSponsorChildren's Hospital Medical Center, CincinnatiRan2019 to 2021Enrolled5ConditionsNeurofibromatosis 1ArmsN-acetylcysteine (NAC), Placebo
NCT04481048 phase2completednot on this mapstarted 2021, after this paper: background citation

Antioxidant Therapy With N-acetylcysteine for Motor Behavior and/or Learning in Children With Neurofibromatosis Type 1

TypeinterventionalSponsorChildren's Hospital Medical Center, CincinnatiRan2021 to 2024Enrolled25ConditionsNeurofibromatosis 1ArmsN-Acetyl cysteine, Placebo
NCT06260566 phase1not yet recruitingnot on this mapstarted 2026, after this paper: background citation

A Phase 1 Trial of Tolerability of Enteral N-Acetylcysteine in Infants

TypeinterventionalSponsorSanjiv HarpavatRan2026 to 2031Enrolled12ConditionsBiliary AtresiaArmsN-Acetylcysteine
3 · Its place in the literature

Who cites it

113 citing papers in PubMed, 8 syntheses or guidelines pooled it, 285 citations in OpenAlex.

  1. Pooled it
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  8. Assessment and management of treatment-refractory obsessive-compulsive disorder in children.Journal of the American Academy of Child and Adolescent Psychiatry · 2015
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  16. Weight Gain and Metabolic Consequences of Risperidone in Young Children With Autism Spectrum Disorder.Journal of the American Academy of Child and Adolescent Psychiatry · 2016
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53 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 1 country.

Antonio Y HardanDepartment of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California 94305, USA. hardanay@stanford.edu
Lawrence K Fung
Robin A Libove
Tetyana V Obukhanych
Surekha Nair
Leonore A Herzenberg
Thomas W Frazier
Rabindra Tirouvanziam
Stanford University · USCleveland Clinic · USStanford Medicine · US

Funding

Case Western Reserve University/Cleveland Clinic CTSA (KL2)KL2RR024990 · NCRR · CASE WESTERN RESERVE UNIVERSITY · PI DAVIS, PAMELA B · 2007 to 2011
$9.5M
NCRR NIH HHS KL2 RR024990
6 · The paper itself

Abstract

backgroundAn 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.

methodsThis 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.

resultsThirty-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).

conclusionsData from this pilot investigation support the potential usefulness of NAC for treating irritability in children with autistic disorder. Large randomized controlled investigations are warranted.

Indexed as

AcetylcysteineAutistic DisorderChildChild, PreschoolDouble-Blind MethodFemaleFree Radical ScavengersHumansIrritable MoodMalePilot ProjectsStereotyped BehaviorTreatment OutcomeAcetylcysteineFree Radical Scavengers

Identifiers

PMID22342106
PMCPMC4914359
OpenAlexW2147802796

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.