Bumetanide for the Autism Spectrum Clinical Effectiveness Trial

Conditions: Autism Spectrum Disorders (ASDs)
Epilepsy

Registration Number: NL-OMON20585

Lead Sponsor: niversity Medical Center Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 172

Inclusion Criteria

1. Males and females aged 5-15 years

2. Above ASD cut-off scores on the Social Responsiveness Scale and either a clinical
ASD diagnosis based on DSM-5 (or DSM-IV) or an epilepsy diagnosis

Exclusion Criteria

1. Total IQ<55

2. Presence of a severe medical or genetic disorder other than related to ASD or epilepsy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Aberrant Behavior Checklist (ABC) Irritability Subscale

Secondary Outcome Measures

Name	Time	Method
- World Health Organization Quality of life (WHOQOL-BREF)<br /><br>- EQ5D-5L; EQ5D-Youth<br /><br>- BRIEF<br /><br>- Productivity Cost Questionnaire (iPCQ)<br /><br>- Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P)<br /><br>- ABC sub scales<br /><br>- Repetitive Behavior Scale (RBS-V)<br /><br>- Social Responsiveness Scale (SRS)<br /><br>- Sensory Profile (SP-NL)<br /><br>- SP School Sompanion (SP-SC)<br /><br>Epilepsy related variables (if applicable)<br /><br>- Seizure frequency<br /><br>- Number of occasions rescue medication is necessary