The use of Oxytocin for Autism Spectrum Disorders: Investigating the effect on behavior and at the level of the brain.

Oxytocin-based pharmacotherapy for Autism Spectrum Disorders: Investigating the neural and behavioral effects of a promising intervention approach - Oxytocin study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000586-45-BE

Enrollment

Registered

2014-03-27

Start date

2014-05-08

Completion date

Unknown

Last updated

2025-01-13

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

Conditions

Young male adults with Autism Spectrum Disorders (18-30 years) MedDRA version: 16.1 Level: LLT Classification code 10003808 Term: Autistic disorder System Organ Class: 100000004852

Interventions

Trade Name: Syntocinon (oxytocin), nasal spray 40 IE/ml Product Name: Syntocinon (oxytocin) Product Code: RVG 03716 Pharmaceutical Form: Nasal spray Pharmaceutical form of the placebo: Nasal spray Rou

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Young male adult participants with autism spectrum disorder will be recruited mainly from the Expertise Centrum Autisme (ECA) of the UZ Leuven, Belgium. Participants are selected when diagnosed with ASD by a multidisciplinary team of experienced clinicians as defined by the DSMIV- TR (or DSM-V) criteria (Diagnostic and Statistical Manual of Mental Disorders). In addition to the DSM-criteria, the Developmental Dimensional Diagnostic instrument (3DI, David Skuse) and the Autism Diagnostic Observation Schedule (ADOS) will be adopted as diagnostic tests. Participants within an age-range of 18-30 will be included. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Participants will be excluded based on the following criteria: (i) associated psychiatric or neurological disorders (e.g. ADHD), (ii) use of psychotropic medication, (iii) any contraindication to neuroimaging research as assessed with the MRI screening list (see below) MRI contraindications pacemaker, implanted defibrillator, ear implant / a cochlear implant, insulin or implanted pump, a neurostimulator or VP shunt, any metallic object in the eyes (metallic fragments)

Design outcomes

Primary

Measure	Time frame
Main Objective: The current trial aims to explore the neural and behavioral effects of oxytocin in autism spectrum disorders (ASD). Initial studies showed that intranasal administration of oxytocin can have a positive effect on social functioning in ASD. However, future studies are necessary to explore whether and how oxytocin effects neural processes in the brain underlying these behavioral improvements. This trial will not only measure behavioral enhancements, but will specifically focus on elucidating the associated neurophysiological changes by guiding the administration of oxytocin with regular neurophysiological assessments.;Secondary Objective: Not applicable;Primary end point(s): This study will provide results on the effects oxytocin on social functioning and the associated changes in brain function/connectivity/structure in autism spectrum disorders.;Timepoint(s) of evaluation of this end point: The end of the trial is anticipated June 2016.	—

Measure

Time frame

Main Objective: The current trial aims to explore the neural and behavioral effects of oxytocin in autism spectrum disorders (ASD). Initial studies showed that intranasal administration of oxytocin can have a positive effect on social functioning in ASD. However, future studies are necessary to explore whether and how oxytocin effects neural processes in the brain underlying these behavioral improvements. This trial will not only measure behavioral enhancements, but will specifically focus on elucidating the associated neurophysiological changes by guiding the administration of oxytocin with regular neurophysiological assessments.;Secondary Objective: Not applicable;Primary end point(s): This study will provide results on the effects oxytocin on social functioning and the associated changes in brain function/connectivity/structure in autism spectrum disorders.;Timepoint(s) of evaluation of this end point: The end of the trial is anticipated June 2016.

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Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Belgium

Contacts

Public ContactDr. K. Alaerts

KU Leuven

kaat.alaerts@faber.kuleuven.be003216376446

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 28, 2026