EUCTR2014-000586-45-BEActive, not recruitingPhase 1
Oxytocin-based pharmacotherapy for Autism Spectrum Disorders:Investigating the neural and behavioral effects of a promising interventionapproach - Oxytocin study
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- KU Leuven
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Male
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
- •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
- •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)
Investigators
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