Sulforaphane as an adjunctive treatment for irritability in children with autism spectrum disorder: A randomized, double-blind, placebo-controlled clinical trial
Momtazmanesh S, Amirimoghaddam-Yazdi Z, Moghaddam HS, Mohammadi MR, Akhondzadeh S
Psychiatry and clinical neurosciences · 54 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
- Consumo medido con
- No se indica
Quién lo pagó
- Financiación
- Financiación independiente
- Universidad u hospital
- Tehran University of Medical Sciences and Health Services
- Subvenciones
- Tehran University of Medical Sciences and Health Services (37048)
Según 1 financiador declarado.
Publicación
- Publicado
- 2020-04-29 · Psychiatry Clin Neurosci · vol. 74 · número 7 · págs. 398–405
- Editorial
- Wiley
- Citado
- 63 citas · más que el 91% de estudios similares · 2.9× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 54 trabajos
- Acceso
- De pago
- Áreas de investigación
- Autism Spectrum Disorder Research · Child Nutrition and Feeding Issues · Schizophrenia research and treatment
- Palabras clave
- sulforaphane, autism spectrum disorder, irritability, risperidone, adjunctive therapy, hyperactivity, children, Aberrant Behavior Checklist, adverse events
- MeSH
- humans, inflammation, isothiocyanates, sulfoxides, risperidone, antipsychotic agents, anti-inflammatory agents, antioxidants, treatment outcome, drug therapy, combination, double-blind method, irritable mood, oxidative stress, child, child, preschool, female, male, autism spectrum disorder
5 autores
- Sara Momtazmanesh🇮🇷Roozbeh Hospital; Tehran University of Medical Sciences
- Zeinab Amirimoghaddam‐Yazdi🇮🇷Roozbeh Hospital; Tehran University of Medical Sciences
- Hossein Sanjari Moghaddam🇮🇷Roozbeh Hospital; Tehran University of Medical Sciences
- Mohammad Reza Mohammadi🇮🇷Roozbeh Hospital; Tehran University of Medical Sciences
- Shahin Akhondzadeh🇮🇷 · autor de correspondenciaRoozbeh Hospital; Tehran University of Medical Sciences
Resumen
El texto original del estudio, en el idioma en que se publicó.
Aim
Irritability related to autism spectrum disorder (ASD) complicates the management of ASD patients at home and in clinical settings. In this randomized, double-blind, placebo-controlled clinical trial, we aimed to investigate the beneficial effects of adjuvant treatment with risperidone and sulforaphane in alleviating the irritability of children with ASD.
Methods
Sixty drug-free patients aged 4-12 years were randomly assigned to one of two groups receiving risperidone plus sulforaphane or placebo. Risperidone was started with a daily dose of 0.25 mg in patients weighing 45 kg). Sulforaphane was administered at a daily dose of 50 μmol (≤45 kg) or 100 μmol (>45 kg). The participants were assessed with the Aberrant Behavior Checklist - Community Edition at baseline and at Weeks 5 and 10.
Results
Compared to the placebo group, ASD patients in the sulforaphane group showed greater improvements in Irritability score (primary outcome measure; P = 0.001) and Hyperactivity/Noncompliance score (secondary outcome measure; P = 0.015), and significant Time × Treatment effect for Irritability (P = 0.007) and Hyperactivity/Noncompliance (P = 0.008). However, no difference was seen in improvements in the other secondary measures: Lethargy/Social Interaction score, Stereotypic Behavior score, Inappropriate Speech score, and frequency of adverse events.
Conclusion
Our results support the safety and efficacy of sulforaphane as an adjuvant to risperidone for improvement of irritability and hyperactivity symptoms in children with ASD.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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