Evaluation of oxytocin treatment in children with autism and intellectual disability’, Multiple-dose Oxytocine - ASD and Intellectual Disability

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513436-14-00

Enrollment

Registered

2024-09-20

Start date

2023-05-30

Completion date

Unknown

Last updated

2025-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism spectrum disorder (ASD)

Brief summary

The Brief Observation of Social Communication Change (BOSCC) (clinician-rated), The Autism Treatment Evaluation Checklist (ATEC) (parent (caregiver) and teacher-rated), Recordings of electrocardiography (ECG) for the assessment of heart rate variability (HRV) during rest

Detailed description

The Repetitive Behavior Scale - Revised (RBS-R) (parent (caregiver) and teacher-rated), The Adaptive Behavior Assessment System (ABAS-3) (parent (caregiver)-rated), The Developmental Behaviour Checklist (DBC) (parent (caregiver)-rated), The Perceived Stress Scale (PSS) (parent (caregiver)-rated), The Child’s Sleep Habits Questionnaire Abbreviated (CSHQ-A) (parent (caregiver)-rated)

Interventions

DRUGsodium chloride nose drops 0.9%

DRUGOxytocine CD Pharma 40 IE/ml neusspray

DRUGoplossing

DRUGSyntocinon 40 IE/ml neusspray

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
The Brief Observation of Social Communication Change (BOSCC) (clinician-rated), The Autism Treatment Evaluation Checklist (ATEC) (parent (caregiver) and teacher-rated), Recordings of electrocardiography (ECG) for the assessment of heart rate variability (HRV) during rest	—

Secondary

Measure	Time frame
The Repetitive Behavior Scale - Revised (RBS-R) (parent (caregiver) and teacher-rated), The Adaptive Behavior Assessment System (ABAS-3) (parent (caregiver)-rated), The Developmental Behaviour Checklist (DBC) (parent (caregiver)-rated), The Perceived Stress Scale (PSS) (parent (caregiver)-rated), The Child’s Sleep Habits Questionnaire Abbreviated (CSHQ-A) (parent (caregiver)-rated)	—

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026