Neural and Behavioral Effects of Oxytocin in Autism Spectrum Disorders

NCT ID: NCT02940574

Last Updated: 2021-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2019-12-31

Brief 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.

Detailed Description

The present study is a monocentric, between-subjects, randomized, placebo-controlled trial. The investigators will recruit approximately 40 young-adult, male individuals with a clinical diagnosis of Autism Spectrum Disorder (ASD). Participants will be randomly allocated to an experimental group (Oxytocin (OT)) and a control group (Placebo (PL)). All participants will receive the same frequency and duration of intervention. Behavioral and neural outcome measures will be assessed at multiple time points in a period of a year. Participants will be tested at 5 occasions: before and after a single dose of nasal spray, after multiple doses of nasal spray (1 daily dose of nasal spray during 4 weeks), after a 4-week retention period and after a 1-year retention period. At each time point participants will be tested at both the behavioral and neural level. Test performance of both participant groups (OT vs PL) will be compared by measuring reaction times and accuracy rates in a computerized task assessing a person's ability to recognize bodily emotional states from point light displays. In addition, attachment, social functioning, restricted behaviour, general quality of life and mood will be assessed via self-reported questionnaires.

Functional MRI measurements will be performed in a 3T MR Philips Intera scanner. Before scanning, subjects will undergo a training session to familiarize them with the task instructions. In addition to the fMRI measurements, resting state fMRI and Diffusion Tensor Imaging (DTI) will also be performed to reveal alterations of the functional and structural connectivity between critical regions.

Statistical analysis of the behavioral data will have a between-subject factor of group (OT vs PL) and within-subject factors of time (change-from-baseline). Image analysis will be performed with Statistical Parametric Mapping (SPM) software. The investigators will contrast for either decreased or increased activation, as different regions may show divergent changes due to the received nasal spray (either OT or PL).

Conditions

Autism Spectrum Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Syntocinon (Oxytocin, product code RVG 03716)

Administration via nasal spray

Group Type: EXPERIMENTAL

Syntocinon (Oxytocin)

Intervention Type: DRUG

Syntocinon nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray

Placebo (Physiological water(sodium chloride (NaCl) solution))

Administration via nasal spray

Group Type: PLACEBO_COMPARATOR

Placebo (Physiological water (solution of sodium chloride (NaCl) in water))

Intervention Type: OTHER

Placebo nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray

Interventions

Syntocinon (Oxytocin)

Syntocinon nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray

Intervention Type: DRUG

Placebo (Physiological water (solution of sodium chloride (NaCl) in water))

Placebo nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

The Branco Weiss Fellowship

OTHER

Sponsor Role: collaborator

Research Foundation Flanders

OTHER

Sponsor Role: collaborator

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Kaat Alaerts

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kaat Alaerts, PhD

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

References

Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.

Reference Type: DERIVED

PMID: 37811711 (View on PubMed)

Other Identifiers

2014-000586-45

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

S56327

Identifier Type: -

Identifier Source: org_study_id