Interest of Oxytocin as an Adjuvant Treatment of Psycho-educational Measures in Challenging Behaviors in Children With Autism Spectrum Disorders and Moderate to Severe Intellectual Disability: Feasibility and Safety Study. (OT-DEFI)

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516306-28-00

Acronym

RC31/19/0500

Enrollment

Registered

2024-09-10

Start date

2025-02-12

Completion date

Unknown

Last updated

2025-08-19

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

Conditions

Autism with Spectrum Disorders and Moderate to Severe Intellectual Disability

Brief summary

The results will be considered positive if this percentage is greater than or equal to 80%, with a lower limit of the confidence interval of this estimate beyond 61.4%.

Detailed description

Precise statement of the reasons for a possible interruption of the protocol, Qualitative assessment by caregivers and parents of the heaviness of implementing the protocol through semi-directive qualitative and quantitative interviews, - Results of the questionnaires

Interventions

DRUGSODIUM CHLORIDE

DRUGOXYTOCIN

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
The results will be considered positive if this percentage is greater than or equal to 80%, with a lower limit of the confidence interval of this estimate beyond 61.4%.	—

Secondary

Measure	Time frame
Precise statement of the reasons for a possible interruption of the protocol, Qualitative assessment by caregivers and parents of the heaviness of implementing the protocol through semi-directive qualitative and quantitative interviews, - Results of the questionnaires	—

Countries

France

Outcome results

None listed

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