Autism Spectrum Disorders MedDRA version: 20.0 Level: LLT Classification code 10003808 Term: Autistic disorder System Organ Class: 100000004873
Conditions
Sponsors
University Hospital, KU Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Exploring the effects and mechanism of multiple-dose oxytocin treatment (OT) in children with Autism Spectrum Disorders (ASD) (age 8-12 years). The principal aim of the current clinical trial is to explore the effects and mechanism of multiple-dose OT treatment in children with ASD, by assessing the effects of treatment both at the neural and the behavioral level. ;Secondary Objective: A secondary objective of the trial is to explore the effects of multiple-dose OT treatment on physiological measurements of stress (e.g., heart rate variability, skin conductance, and respiration) and to identify mediating factors that may modulate treatment responses (e.g. symptom severity, OT concentration, epigenetic variations of the OT receptor gene). Furthermore, by adopting an extensive neuroimaging protocol (both EEG and MRI) and assessments of physiological measurements of stress (e.g., heart rate variability, skin conductance, and respiration), the current study will allow to specifically explore whether and how neural changes are related to changes in these physiological indices. ;Primary end point(s): The primary aims of this project are assessing the change from baseline after oxytocin administration on: - Brain activity measured with Magnetic Resonance Imaging (MRI) (a) During tasks – Task based functional MRI: Eye Gaze and Fast Periodic Visual Stimulation Paradigm (b) During rest – Resting state functional MRI - Brain activity measured with Electro-encephalography (EEG) (a) During tasks – Task based EEG: Eye Gaze and Fast Periodic Visual Stimulation Paradigm (b) During rest – Resting state EEG - Behavioral assessments of autism symptoms (social functioning, repetitive behavior), (social) anxiety, attachment ;Timepoint(s) of evaluation of this end point: The end of the trial is anticipated September 2021. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary aims of this project are assessing the change from baseline after oxytocin administration on: - Physiological measurments Heart rate and heart rate variability Skin conductance Respiration - Endogene measurements of oxytocin and cortisol levels measured in saliva samples The clinical trial will also include two exploratory outcome measures: - additional saliva samples, to explore the level of epigenetic modifications of the oxytocin receptor gene - mouth swaps, to assess microbiome compositions - fecal samples, to assess microbiome compositions ;Timepoint(s) of evaluation of this end point: The end of the trial is anticipated September 2021. | — |
Countries
Belgium
Contacts
Public ContactProf. Dr. K. Alaerts
University Hospital, KU Leuven
Outcome results
None listed