Evidence map›Paper›PMID 35292925›Full record

Trial reportChild psychiatry and human development2023

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.

Christina Georgoula, Maite Ferrin, Bozena Pietraszczyk-Kedziora, Amaia Hervas, Stéphane Marret, Guiomar Oliveira, Antoine Rosier, Véronique Crutel, Emmanuelle Besse, Cristina Albarrán Severo and 2 more

Abstract readRandomized Controlled TrialClinical Trial, Phase III
PubMed Publisher
In one paragraph

Trial report in Child psychiatry and human development, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.4field-weighted citation impact, top 21% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 13 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 6 institutions in 3 countries.

Christina GeorgoulaReCognition Health, London, UK.
Maite FerrinReCognition Health, London, UK.
Bozena Pietraszczyk-KedzioraChild and Adolescent Psychiatry Unit, Niepubliczny Zakład Opieki Zdrowotnej Gdańskie Centrum Zdrowia, Gdańsk, Poland.
Amaia HervasChild and Adolescent Mental Health Unit, Hospital Universitari Mútua de Terrassa, and Global Institute of Neurodevelopment Integrated Care (IGAIN), Barcelona, Spain.
Stéphane MarretDepartment of Neonatal Pediatrics, Intensive Care, and Neuropediatrics, Rouen University Hospital and INSERM U 1245 Team 4 Neovasc, School of Medicine, Normandy University, Rouen, France.
Guiomar OliveiraNeurodevelopmental and Autism Unit From Child Developmental Center and Centro de Investigação e Formação Clínica, Hospital Pediátrico, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal.
Antoine RosierDepartment of Neonatal Pediatrics, CHU de Rouen and CHU le Rouvray, Sotteville les Rouen, France.
Véronique CrutelNeuro Inflammation Therapeutic Area, Institut de Recherches Internationales Servier, 50 Rue Carnot, 92284, Suresnes CEDEX, France.
Emmanuelle BesseNeuro Inflammation Therapeutic Area, Institut de Recherches Internationales Servier, 50 Rue Carnot, 92284, Suresnes CEDEX, France.
Cristina Albarrán SeveroNeuro Inflammation Therapeutic Area, Institut de Recherches Internationales Servier, 50 Rue Carnot, 92284, Suresnes CEDEX, France. cristina.albarran-severo@servier.com.
Denis RavelNeurochlore, Marseille, France.
Joaquin FuentesChild & Adolescent Psychiatry Service, Policlínica Gipuzkoa and Gipuzkoa Autism Society (GAUTENA), Donostia/San Sebastián, Spain.
Servier (France) · FRCentre Hospitalier du Rouvray · FRHospitais da Universidade de Coimbra · PTInserm · FRMútua Terrassa · ESPoliclínica Gipuzkoa · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Autism Spectrum DisorderAutistic DisorderAdolescentBumetanideChildDouble-Blind MethodFemaleHumansMaleTreatment OutcomeBumetanideAutism spectrum disorderBumetanidePaediatricsRandomised controlled trial

Identifiers

PMID35292925
OpenAlexW4220752015

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.