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Clinical Trials in the EU / 2025-524797-42-00
Authorised, not yet recruiting Phase III

Assessment of self-perceived stress and repetitive behaviors after six weeks of daily intranasal oxytocin administration versus placebo: a randomised, multicentre, parallel group pragmatic trial in 210 men and women with autism

2025-524797-42-00 · tracked via the Priya Life Science EU tracker
Sponsor
UZ Leuven
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Mental Disorders
Decision date
03/11/2026
Enrollment target
210
Sites
Belgium

Condition studied

Autism Spectrum Disorder

Investigational medicinal product(s)

Placebo - physiological water-based nasal sprays (NaCl 0.9%)Oxytocin CD Pharma 6,7 mikrogram/dos nässpraylösning

Every trial of Oxytocin across our registers →

Eligibility

Age group
65+ years, 18-64 years
Sex
Female, Male

Primary endpoint

The self-perceived stress assessment at T1 (7 weeks after randomization and following the six week IMP administration) of the Perceived stress scale (PSS-10) compared to the assessment at baseline

Endpoint detail

The PSS-10 assessment at the follow-up sessions T2, T3, and T4

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-524797-42-00 on CTIS ↗ ← All trials in the EU