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

Phase 1

• Conditions: Autism Spectrum Disorders; MedDRA version: 20.0Level: LLTClassification code 10003808Term: Autistic disorderSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Psychological processes [F02]

• Registration Number: EUCTR2018-000769-35-BE
• Lead Sponsor: niversity Hospital, KU Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-07
• Study Completion: 2021-08-30
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Patients eligible for inclusion in this Trial have to meet all of the following criteria:
1. Written informed consent must be obtained prior to any screening procedures
2. Male participants within an age-range of 8 to 12 years old ; only female participants at pre-puberty within this age-range at the onset of participation in the trial
3. Stable background treatment during four weeks prior to screening

Additionally, participants for the Trial Oxytocin treatment must meet the following criterium:
1. Diagnosed with ASD by a multidisciplinary team of experienced clinicians as defined by the DSM-IV-TR or DSM- IV-TR criteria (Diagnostic and Statistical Manual of Mental Disorders).

Note that 30 typically develloped (control) participants, with no diagnosis of ASD (age range 8-12 years) will be recruited to participate in the baseline assessments (no administration of oxytocin).

Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients eligible for this Trial must not meet any of the following criteria:
1. Patient has history of any neurological disorder (stroke, concussion, epilepsy etc).
2. Significant hearing or vision impairments.
3. Non-Dutch native speaker.
4. Verbal IQ below 70.
5. Regular nasal obstruction or nosebleeds.
6. Current or prior use of oxytocin.
7. Participation in another Clinical Trial.
8. Known hypersensitivity to active substance or excipients in nasal sprays.
9. (Significant) change in background treatments.
10. any contraindication to MRI research
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