OXYTOCIN for Autism Spectrum Disorder

Inclusion criteria

• {"criterion_text":"- Voluntary written informed asent of the participant if possible and voluntary informed consent of their legally authorized representative has been obtained prior to any screening procedures\n- Participants participating in the ASD group must have a formal ASD diagnosis, established by a multidisciplinary team of experienced clinicians as defined by the DSM-IV-TR or DSM-5- criteria (Diagnostic and Statistical Manual of Mental Disorders)\n- Male participants within an age-range of 8 to 12 years old; only female participants at pre-puberty within this age-range on the day of the study visit\n- Estimated Verbal Comprehension Index and Visiual Spatial Index determined by the WISC-V-NL above 70\n- Psychopharmacological medication and psychosocial therapy must remain stable during four weeks prior to the intake visit and during four weeks prior to the study visit"}

Exclusion criteria

• {"criterion_text":"- Known hypersensitivity to active substance or excipients in nasal sprays\n- Participants participating in the NT group or their first-degree relatives has a diagnosis of autism, and/or any psychiatric or neurological disorder that may affect the safety of the participant or the integrity of the trial.\n- Participants participating in the NT group must not have a total SRS T-score of ≥ 60\n- Any active medical condition (neurological, psychiatric, developmental, gastrointestinal, motoric disorders, etc., other than ASD or comorbid ADHD in participants with ASD) that may affect the safety of the participant, the integrity of the trial, or the effect of the IMP.\n- Any anti-epileptic medication and/or any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial\n- Participation in an interventional Trial with an investigational medicinal product (IMP) or device\n- Significant hearing or vision impairments\n- Non-Dutch native speaker\n- Regular nasal obstruction or nosebleeds\n- Subjects who recently have had previous chronic treatment with oxytocin"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint of this project is the change from baseline treatment effects on dyadic attunement in children with ASD and the experimenter, determined by multimodal measures of neurophysiological and behavioral responses as defined in the study protocol, during screen-based and real-life social interaction paradigms","definition_or_measurement_approach":"Change from baseline in dyadic attunement determined by multimodal measures of neurophysiological and behavioral responses as defined in the study protocol, assessed during screen-based and real-life social interaction paradigms."}

Secondary endpoints

• {"endpoint_text":"- The secondary endpoint of this project is the change from baseline treatment effects on post-intervention endogenous oxytocin and cortisol levels measured in saliva samples","definition_or_measurement_approach":"Change from baseline in post-intervention endogenous oxytocin and cortisol levels measured in saliva samples."}

Methods

• Recruitment arrangements documented (K1_Recruitment and Informed consent procedure) – country: Belgium
• Recruitment material - Flyer (paper) – channel: printed flyer; target audience: participants/parents/school organisations; country: Belgium
• Recruitment material - Paper Poster – channel: printed poster; target audience: participants/parents/school organisations; country: Belgium
• Recruitment material - Digital Poster / Digital Poster Vertical – channel: digital/online poster; target audience: participants/parents/school organisations; country: Belgium
• Information letters and ICF documents for minors, parents, school organisations and experimenter (subject information and informed consent forms) – channel: written information provided to participants/parents; country: Belgium

Belgium

Earliest CTIS Part Ii Submission Date

15-02-2024

Latest Decision Or Authorization Date

19-03-2026

Processing Time Days

763

Number Of Sites

1

Number Of Participants

140

Primary sponsor

Full Name

UZ Leuven

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium

Third parties

• {"country":"","full_name":"Apotheek A15 B.V.","duties_or_roles":"Source of monetary support / repackaging described in product change description","organisation_type":""}
• {"country":"","full_name":"Fonds voor Wetenschappelijk Onderzoek - Vlaanderen","duties_or_roles":"Source of monetary support","organisation_type":""}