The use of Oxytocin for Autism Spectrum Disorders: Investigating theeffect on behavior and at the level of the brain.
- Conditions
- Young male adults with Autism Spectrum Disorders (18-30 years)MedDRA version: 16.1Level: LLTClassification code 10003808Term: Autistic disorderSystem Organ Class: 100000004852Therapeutic area: Psychiatry and Psychology [F] - Psychological processes [F02]
- Registration Number
- EUCTR2014-000586-45-BE
- Lead Sponsor
- KU Leuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 40
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
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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The current trial aims to explore the neural and behavioral effects of<br>oxytocin in autism spectrum disorders (ASD).<br>Initial studies showed that intranasal administration of oxytocin can<br>have a positive effect on social functioning in ASD. However, future<br>studies are necessary to explore whether and how oxytocin effects<br>neural processes in the brain underlying these behavioral improvements.<br>This trial will not only measure behavioral enhancements, but will<br>specifically focus on elucidating the associated neurophysiological<br>changes by guiding the administration of oxytocin with regular<br>neurophysiological assessments.;Secondary Objective: Not applicable;Primary end point(s): This study will provide results on the effects oxytocin on social<br>functioning and the associated changes in brain<br>function/connectivity/structure in autism spectrum disorders.;Timepoint(s) of evaluation of this end point: The end of the trial is anticipated June 2016.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable