Neural and Behavioral Effects of Oxytocin in Autism Spectrum Disorders

NCT02940574 | Completed Phase 4 Results

• 2 other identifiers: S563272014-000586-45
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Autism Spectrum Disorders

Keywords

Oxytocin; Autism Spectrum Disorders

Outcome Measures

Primary Outcomes (8)

• Change From Baseline in Brain Activity During Task (Task-based fMRI) After a Single Dose of Nasal Spray

  Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) After a Single Dose of Nasal Spray BOLD response (Blood-oxygen-level-dependent response)

  Value at 30 minutes minus value at baseline

• Change From Baseline in Brain Activity During Task (Task-based fMRI) After 4 Weeks of Nasal Spray

  Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) after 4 weeks of nasal spray BOLD response (Blood-oxygen-level-dependent response)

  Value at 4 weeks minus value at baseline

• Change From Baseline in Brain Activity During Task (Task-based fMRI) After 8 Weeks, Including 4 Weeks Without Nasal Spray

  Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) after 8 weeks, including 4 weeks without nasal spray BOLD response (Blood-oxygen-level-dependent response)

  Value at 8 weeks minus value at baseline

• Change From Baseline in Brain Activity During Task (Task-based fMRI) After 52 Weeks, Including 48 Weeks Without Nasal Spray

  Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) after 52 weeks, including 48 weeks without nasal spray BOLD response (Blood-oxygen-level-dependent response)

  Value at 52 weeks minus value at baseline

• Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After a Single Dose of Nasal Spray

  Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After a Single Dose of Nasal Spray Amygdala connectivity (Change-from-baseline z-transformed r-value) Higher z-transformed r-value indicates higher connectivity (higher correlated brain activity)

  Value at 30 minutes minus value at baseline

• Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 4 Weeks of Nasal Spray

  Change from baseline in brain connectivity during rest (resting-state fMRI) after 4 weeks of nasal spray Amygdala connectivity (Change-from-baseline z-transformed r-value) Higher z-transformed r-value indicates higher connectivity (higher correlated brain activity)

  Value at 4 weeks minus value at baseline

• Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 8 Weeks, Including 4 Weeks Without Nasal Spray

  Change from baseline in brain connectivity during rest (resting-state fMRI) after 8 weeks, including 4 weeks without nasal spray Amygdala connectivity (Change-from-baseline z-transformed r-value) Higher z-transformed r-value indicates higher connectivity (higher correlated brain activity)

  Value at 8 weeks minus value at baseline

• Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 52 Weeks, Including 48 Weeks Without Nasal Spray

  Change from baseline in brain connectivity during rest (resting-state fMRI) after 52 weeks, including 48 weeks without nasal spray Amygdala connectivity (Change-from-baseline z-transformed r-value) Higher z-transformed r-value indicates higher connectivity (higher correlated brain activity)

  Value at 52 weeks minus value at baseline

Secondary Outcomes (8)

• Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/Reaction Time) After a Single Dose of Nasal Spray

  Value at 30 minutes minus value at baseline

• Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/ Reaction Time) After 4 Weeks of Nasal Spray

  Value at 4 weeks minus value at baseline

• Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/ Reaction Time) After 8 Weeks (Including 4 Weeks Without Nasal Spray)

  Value at 8 weeks minus value at baseline

• Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/ Reaction Time) After 52 Weeks (Including 48 Weeks Without Nasal Spray)

  Value at 52 weeks minus value at baseline

• 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

  Value at 4 weeks minus value at baseline

Study Arms (2)

Syntocinon (Oxytocin, product code RVG 03716)

EXPERIMENTAL

Administration via nasal spray

Drug: Syntocinon (Oxytocin)

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

PLACEBO COMPARATOR

Administration via nasal spray

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

Interventions

Syntocinon (Oxytocin) 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

Syntocinon (Oxytocin, product code RVG 03716)

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

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• KU Leuven: lead
• The Branco Weiss Fellowship: collaborator
• Research Foundation Flanders: collaborator

Related Publications (1)

• 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.

  PMID: 37811711 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Prof. Dr. Kaat Alaerts
• Organization: KU Leuven

kaat.alaerts@kuleuven.be

16 37 64 46

Study Officials

• Kaat Alaerts, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 19, 2016
• First Posted: October 21, 2016
• Study Start: April 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2019
• Last Updated: February 10, 2021
• Results First Posted: February 13, 2020

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share