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Clinical Trials/EUCTR2014-000586-45-BE
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

KU Leuven0 sites40 target enrollmentStarted: March 27, 2014Last updated:
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

Sponsor
KU Leuven

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