Trial reportBMC psychiatry2013
A randomized double blind placebo controlled clinical trial of N-Acetylcysteine added to risperidone for treating autistic disorders.
Trial report in BMC psychiatry, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 56 papers, 4 of them syntheses that pooled 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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
56 citing papers in PubMed, 4 syntheses or guidelines pooled it, 146 citations in OpenAlex.
- Navigating agitation in neurodevelopmental disorders: A comparative study of pharmacotherapies via network meta-analysis in children and adults with autism spectrum disorder or intellectual disabilities.Journal of psychopharmacology (Oxford, England) · 2025Pooled it
- Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD).The Cochrane database of systematic reviews · 2023Pooled it
- Impact of antipsychotics in children and adolescents with autism spectrum disorder: a systematic review and meta-analysis.Health and quality of life outcomes · 2021Pooled it
- Predictors of placebo response in pharmacological and dietary supplement treatment trials in pediatric autism spectrum disorder: a meta-analysis.Translational psychiatry · 2015Pooled it
- Effects of N-acetylcysteine on oxidative stress biomarkers, depression, and anxiety symptoms in patients with multiple sclerosis.Neuropsychopharmacology reports · 2023Trial
- Findings from a pilot open-label trial of N-acetylcysteine for the treatment of pediatric mania and hypomania.BMC psychiatry · 2022Trial
- A randomized placebo-controlled pilot study of N-acetylcysteine in youth with autism spectrum disorder.Molecular autism · 2016Trial
- Beyond the Outburst: Charting a New Frontier for Understanding and Treating Irritability in Autistic Adults.Autism research : official journal of the International Society for Autism Research · 2026Review
- Medical treatment of autism spectrum disorder in children: Current evidence, controversies, and clinical challenges.World journal of clinical pediatrics · 2026Article
- Clinical outcomes of mitochondrial-enhancing nutraceutical supplementation in psychiatric disorders: A systematic review.General psychiatry · 2026Article
- Novel therapeutics in autism spectrum disorder.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026Review
- Oxidative stress response and NRF2 signaling pathway in autism spectrum disorder.Redox biology · 2025Review
- Heavy metals, noradrenaline/adrenaline ratio, and microbiome-associated hormone precursor metabolites: biomarkers for social behaviour, ADHD symptoms, and executive function in children.Scientific reports · 2025Article
- Urine Metabolomic Profiling and Machine Learning in Autism Spectrum Disorder Diagnosis: Toward Precision Treatment.Metabolites · 2025Article
- Microbiome-Gut-Brain Axis: Implications for the Links Between Inflammatory Bowel Disease and Neuropsychiatric Disorders.Journal of inflammation research · 2025Review
- Autism spectrum disorder and the role of nuclear hormone receptors: insights and therapeutic implications.Frontiers in neuroscience · 2025Review
- An Overview of Pharmacotherapy in the Management of Children with Autism Spectrum Disorder at a Public Hospital in KwaZulu-Natal.Child psychiatry and human development · 2024Article
- Amygdalar neurotransmission alterations in the BTBR mice model of idiopathic autism.Translational psychiatry · 2024Article
- Targeting the circadian modulation: novel therapeutic approaches in the management of ASD.Frontiers in psychiatry · 2024Review
- N-acetylcysteine Pharmacology and Applications in Rare Diseases-Repurposing an Old Antioxidant.Antioxidants (Basel, Switzerland) · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis study examined the efficacy and safety of N-acetylcysteine (NAC) augmentation for treating irritability in children and adolescents with autism spectrum disorders (ASD).
methodForty 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.
resultsThe 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.
conclusionsRisperidone 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 registrationThis trial was registered at http://www.irct.ir. The registration number of this trial was IRCT201106103930N6.
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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.