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Child Psychiatry & Human Development
Gepubliceerd in: Child Psychiatry & Human Development 5/2023

16-03-2022 | Original Article

A Phase III Study of Bumetanide Oral Liquid Formulation for the Treatment of Children and Adolescents Aged Between 7 and 17 Years with Autism Spectrum Disorder (SIGN 1 Trial): Participant Baseline Characteristics

Auteurs: Christina Georgoula, Maite Ferrin, Bozena Pietraszczyk-Kedziora, Amaia Hervas, Stéphane Marret, Guiomar Oliveira, Antoine Rosier, Véronique Crutel, Emmanuelle Besse, Cristina Albarrán Severo, Denis Ravel, Joaquin Fuentes

Gepubliceerd in: Child Psychiatry & Human Development | Uitgave 5/2023

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Abstract

The efficacy of bumetanide (oral liquid formulation 0.5 mg bid) as a treatment for the core symptoms of autism spectrum disorders in children and adolescents aged 7–17 years is being investigated in an international, randomised, double-blind, placebo-controlled phase III study. The primary endpoint is the change in Childhood Autism Rating Scale 2 (CARS2) total raw score after 6 months of treatment. At baseline, the 211 participants analysed are broadly representative of autistic subjects in this age range: mean (SD) age, 10.4 (3.0) years; 82.5% male; 47.7% with intelligence quotient ≥ 70. Mean CARS2 score was 40.1 (4.9) and mean Social Responsiveness Scale score was 116.7 (23.4). Final study results will provide data on efficacy and safety of bumetanide in autistic children and adolescents.
vorige artikel Associations Between Anxiety and Home Learning Difficulties in Children and Adolescents with ADHD During the COVID-19 Pandemic
volgende artikel Engagement in a Preventive Intervention for Preadolescent Children in Foster Care: Considerations for Intervention Design
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Metagegevens
Titel
A Phase III Study of Bumetanide Oral Liquid Formulation for the Treatment of Children and Adolescents Aged Between 7 and 17 Years with Autism Spectrum Disorder (SIGN 1 Trial): Participant Baseline Characteristics
Auteurs
Christina Georgoula
Maite Ferrin
Bozena Pietraszczyk-Kedziora
Amaia Hervas
Stéphane Marret
Guiomar Oliveira
Antoine Rosier
Véronique Crutel
Emmanuelle Besse
Cristina Albarrán Severo
Denis Ravel
Joaquin Fuentes
Publicatiedatum
16-03-2022
Uitgeverij
Springer US
Gepubliceerd in
Child Psychiatry & Human Development / Uitgave 5/2023
Print ISSN: 0009-398X
Elektronisch ISSN: 1573-3327
DOI
https://doi.org/10.1007/s10578-022-01328-5

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