Phase 4 N=40 Randomized Quadruple-blind Treatment

Neural and Behavioral Effects of Oxytocin in Autism Spectrum Disorders

Autism Spectrum Disorders

Bottom Line

View on ClinicalTrials.gov: NCT02940574 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2020

Primary outcome: Primary: Change From Baseline in Brain Activity During Task (Task-based fMRI) After a Single Dose of Nasal Spray — 0.11; -0.26; -0.15; -0.16 Change-from-baseline (BOLD response)

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Syntocinon (Oxytocin) (Drug); Placebo (Physiological water (solution of sodium chloride (NaCl) in water)) (Other)
Age: Adult · 18+ yrs
Sex: Male
Sponsor: KU Leuven
Primary completion: Dec 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Brain Activity During Task (Task-based fMRI) After a Single Dose of Nasal Spray	0.11; -0.26; -0.15; -0.16	—
PRIMARY Change From Baseline in Brain Activity During Task (Task-based fMRI) After 4 Weeks of Nasal Spray	-0.10; -0.29; -0.09; 0.06	—
PRIMARY Change From Baseline in Brain Activity During Task (Task-based fMRI) After 8 Weeks, Including 4 Weeks Without Nasal Spray	-0.21; -0.16; -0.18; 0.04	—
PRIMARY Change From Baseline in Brain Activity During Task (Task-based fMRI) After 52 Weeks, Including 48 Weeks Without Nasal Spray	-0.18; -0.48; -0.21; 0.03	—
PRIMARY Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After a Single Dose of Nasal Spray	-0.07; 0.03	<0.08
PRIMARY Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 4 Weeks of Nasal Spray	-0.04; 0.11	—
PRIMARY Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 8 Weeks, Including 4 Weeks Without Nasal Spray	-0.07; 0.13	—
PRIMARY Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 52 Weeks, Including 48 Weeks Without Nasal Spray	-0.06; 0.11	—
SECONDARY Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/Reaction Time) After a Single Dose of Nasal Spray	0.000029; 0.000065	—
SECONDARY Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/ Reaction Time) After 4 Weeks of Nasal Spray	0.000044; 0.000073	—
SECONDARY Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/ Reaction Time) After 8 Weeks (Including 4 Weeks Without Nasal Spray)	0.000070; 0.000088	—
SECONDARY Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/ Reaction Time) After 52 Weeks (Including 48 Weeks Without Nasal Spray)	0.000071; 0.000084	—
SECONDARY Change From Baseline in Informant-based/ Self-report Scores on Questionnaires Assessing Attachment, Social Functioning, Quality of Life and Mood After 4 Weeks of Nasal Spray	-5.55; -1.06; 0.0; -0.87; -4.77; -1.76	—
SECONDARY Change From Baseline in Informant-based/ Self-report Scores on Questionnaires Assessing Attachment, Social Functioning, Quality of Life and Mood After 8 Weeks, Including 4 Weeks Without Nasal Spray	-5.64; -7.67; -9.59; -1.20; -4.91; -2.35	—
SECONDARY Change From Baseline in Informant-based/ Self-report Scores on Questionnaires Assessing Attachment, Social Functioning, Quality of Life and Mood After 52 Weeks, Including 48 Weeks Without Nasal Spray	-8.59; -6.72; -7.41; -4.13; -4.91; -0.41	—
SECONDARY Change From Baseline in Scores on Questionnaire Assessing Mood After a Single Dose of Nasal Spray	-1.59; -1.39; -0.09; -0.28; -0.23; -0.67	—

Summary

The current trial aims to explore the neural and behavioral effects of oxytocin in autism spectrum disorders (ASD). Oxytocin is a nonapeptide produced by the paraventricular and supraoptic nuclei of the hypothalamus and is known to play a pivotal role in a variety of complex social behaviors. Initial studies showed that intranasal administration of oxytocin can have a positive effect on social functioning in ASD. However, future studies are necessary to explore whether and how oxytocin effects neural processes in the brain underlying these behavioral improvements. This trial will not only measure behavioral enhancements, but will specifically focus on elucidating the associated neurophysiological changes by guiding the administration of oxytocin with regular neurophysiological assessments.

Eligibility Criteria

Inclusion Criteria

Clinical diagnosis of Autism Spectrum Disorder, Asperger Syndrome or Autism
Male
Age between 18 and 40 years old

Exclusion Criteria

Associated neuro(psycho)logical disorder (i.e. epilepsy, concussion, stroke)
Eye sight worse than + or - 7
Genetic syndrome
Color blindness
Any contraindication to neuroimaging research as assessed with the MRI screening list:

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02940574). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.