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Trial · Interventional

CompletedPhase 4Results postedRegistry data

Neural and Behavioral Effects of Oxytocin in Autism Spectrum Disorders

NCTNCT02940574 (opens ClinicalTrials.gov in a new tab)Other idS56327Other id2014-000586-45Other id2014
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
40 participants (actual)
Sponsor
KU Leuven · Other
Design
Randomized · Quadruple masking
Countries
Not stated
Start
Apr 2015
Primary completion
Dec 2016
Completion
Dec 2019
First posted
21 Oct 2016 (estimated)
Last update posted
10 Feb 2021
Conditions
Autism Spectrum Disorders

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201520162017201820192020
  1. Ph 4

    Neural and Behavioral Effects of Oxytocin in Autism Spectrum Disorders

    NCT02940574

    Apr 2015 to Dec 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Syntocinon (Oxytocin)Drug
  • Placebo (Physiological water (solution of sodium chloride (NaCl) in water))Other

Arms2

  • Experimental

    Syntocinon (Oxytocin, product code RVG 03716)

    Administration via nasal spray

  • Placebo comparator

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

    Administration via nasal spray

Primary outcomes8

Outcomes the sponsor listed as primary.

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

    Time frame · Value at 30 minutes minus value at baseline

    Registry description

    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)

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

    Time frame · Value at 4 weeks minus value at baseline

    Registry description

    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)

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

    Time frame · Value at 8 weeks minus value at baseline

    Registry description

    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)

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

    Time frame · Value at 52 weeks minus value at baseline

    Registry description

    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)

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

    Time frame · Value at 30 minutes minus value at baseline

    Registry description

    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)

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

    Time frame · Value at 4 weeks minus value at baseline

    Registry description

    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)

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

    Time frame · Value at 8 weeks minus value at baseline

    Registry description

    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)

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

    Time frame · Value at 52 weeks minus value at baseline

    Registry description

    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)

Secondary outcomes(8)

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

    Time frame · Value at 30 minutes minus value at baseline

    Registry description

    Change from baseline in performance on the emotion recognition task (accuracy/reaction time) after a single dose of nasal spray Emotion recognition from point-light displays conveying biological motion. Accuracy (acc) is measured in % of correct responses. Reaction time (rt) is measured in milliseconds. Higher (accuracy/ reaction time) ratio indicates better performance.

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

    Time frame · Value at 4 weeks minus value at baseline

    Registry description

    Change from baseline in performance on the emotion recognition task (accuracy/ reaction time) after 4 weeks of nasal spray. Emotion recognition from point-light displays conveying biological motion. Accuracy (acc) is measured in % of correct responses. Reaction time (rt) is measured in milliseconds. Higher (accuracy/ reaction time) ratio indicates better performance.

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

    Time frame · Value at 8 weeks minus value at baseline

    Registry description

    Change from baseline in performance on the emotion recognition task (accuracy/ reaction time) after 8 weeks (including 4 weeks without nasal spray). Emotion recognition from point-light displays conveying biological motion. Accuracy (acc) is measured in % of correct responses. Reaction time (rt) is measured in milliseconds. Higher (accuracy/ reaction time) ratio indicates better performance.

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

    Time frame · Value at 52 weeks minus value at baseline

    Registry description

    Change from baseline in performance on the emotion recognition task (accuracy/ reaction time) after 52 weeks (including 48 weeks without nasal spray) Accuracy (acc) is measured in % of correct responses. Reaction time (rt) is measured in milliseconds. Higher (accuracy/ reaction time) ratio indicates better performance.

  5. 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

    Time frame · Value at 4 weeks minus value at baseline

    Registry description

    The Social Responsiveness Scale (for adults) (SRS-A) uses a four-point Likert-scale. Higher scores indicate lower social responsiveness. The Repetitive Behavior Scale - Revised (RBS-R) uses a four-point Likert-scale. Higher scores indicate a higher frequency and/or higher severity of restricted and repetitive behaviors. The State Adult Attachment Measure (SAAM) uses a seven-point Likert-scale.Higher scores indicate lower perceived secure attachment on the attachment avoidance and attachment anxiety subscales, and higher perceived secure attachment on the attachment security subscale. Inventory of Parent and Peer Attachment (IPPA) uses a four-point Likert-scale. Higher scores indicate indicate increased feelings of secure attachment towards peers or parents. World Health Organization Quality of Life - Bref (WHO-QL) uses a five-point Likert scale. Higher scores indicate better quality of life. Profile of Mood States (POMS). five-point Likert scale.

  6. 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

    Time frame · Value at 8 weeks minus value at baseline

    Registry description

    The Social Responsiveness Scale (for adults) (SRS-A) uses a four-point Likert-scale. Higher scores indicate lower social responsiveness. The Repetitive Behavior Scale - Revised (RBS-R) uses a four-point Likert-scale. Higher scores indicate a higher frequency and/or higher severity of restricted and repetitive behaviors. The State Adult Attachment Measure (SAAM) uses a seven-point Likert-scale.Higher scores indicate lower perceived secure attachment on the attachment avoidance and attachment anxiety subscales, and higher perceived secure attachment on the attachment security subscale. Inventory of Parent and Peer Attachment (IPPA) uses a four-point Likert-scale. Higher scores indicate indicate increased feelings of secure attachment towards peers or parents. World Health Organization Quality of Life - Bref (WHO-QL) uses a five-point Likert scale. Higher scores indicate better quality of life. Profile of Mood States (POMS). five-point Likert scale.

  7. 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

    Time frame · Value at 52 weeks minus value at baseline

    Registry description

    The Social Responsiveness Scale (for adults) (SRS-A) uses a four-point Likert-scale. Higher scores indicate lower social responsiveness. The Repetitive Behavior Scale - Revised (RBS-R) uses a four-point Likert-scale. Higher scores indicate a higher frequency and/or higher severity of restricted and repetitive behaviors. The State Adult Attachment Measure (SAAM) uses a seven-point Likert-scale.Higher scores indicate lower perceived secure attachment on the attachment avoidance and attachment anxiety subscales, and higher perceived secure attachment on the attachment security subscale. Inventory of Parent and Peer Attachment (IPPA) uses a four-point Likert-scale. Higher scores indicate indicate increased feelings of secure attachment towards peers or parents. World Health Organization Quality of Life - Bref (WHO-QOL) uses a five-point Likert scale. Higher scores indicate better quality of life. Profile of Mood States (POMS). five-point Likert scale.

  8. Change From Baseline in Scores on Questionnaire Assessing Mood After a Single Dose of Nasal Spray

    Time frame · Value at 30 minutes minus value at baseline

    Registry description

    Change from baseline in scores on one questionnaire assessing mood (Profile of Mood States - POMS) after a single dose of nasal spray. This instrument comprises emotional adjectives subdivided in five domains: tension (6 items). depression (8 items). vigor (5 items). fatigue (6 items) and anger (7 items) which have to be rated on a five-point Likert scale ranging from 0 (not at all), 1 (a little), 2 (moderately), 3 (quite a lot), to 4 (extremely). Only for the vigor scale, higher scores indicate improvement.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Value at 30 minutes minus value at baseline

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

GroupValue (Change-from-baseline (BOLD response))Spread
Syntocinon (Oxytocin, Product Code RVG 03716)0.110.49
Placebo (Physiological Water(Sodium Chloride (NaCl) Solution))-0.260.72
Primary outcomeMean· Value at 4 weeks minus value at baseline

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

GroupValue (Change-from-baseline (BOLD response))Spread
Syntocinon (Oxytocin, Product Code RVG 03716)-0.100.59
Placebo (Physiological Water(Sodium Chloride (NaCl) Solution))-0.290.68
Primary outcomeMean· Value at 8 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

GroupValue (Change-from-baseline (BOLD response))Spread
Syntocinon (Oxytocin, Product Code RVG 03716)-0.210.58
Placebo (Physiological Water(Sodium Chloride (NaCl) Solution))-0.160.66
Primary outcomeMean· Value at 52 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

GroupValue (Change-from-baseline (BOLD response))Spread
Syntocinon (Oxytocin, Product Code RVG 03716)-0.180.56
Placebo (Physiological Water(Sodium Chloride (NaCl) Solution))-0.480.73
Primary outcomeMean· Value at 30 minutes minus value at baseline

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

GroupValue (Change-from-base z-transformed r-value)Spread
Syntocinon (Oxytocin, Product Code RVG 03716)-0.070.21
Placebo (Physiological Water(Sodium Chloride (NaCl) Solution))0.030.20
Primary outcomeMean· Value at 4 weeks minus value at baseline

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

GroupValue (Change-from-base z-transformed r-value)Spread
Syntocinon (Oxytocin, Product Code RVG 03716)-0.040.22
Placebo (Physiological Water(Sodium Chloride (NaCl) Solution))0.110.21
Primary outcomeMean· Value at 8 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

GroupValue (Change-from-base z-transformed r-value)Spread
Syntocinon (Oxytocin, Product Code RVG 03716)-0.070.17
Placebo (Physiological Water(Sodium Chloride (NaCl) Solution))0.130.18
Primary outcomeMean· Value at 52 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

GroupValue (Change-from-base z-transformed r-value)Spread
Syntocinon (Oxytocin, Product Code RVG 03716)-0.060.20
Placebo (Physiological Water(Sodium Chloride (NaCl) Solution))0.110.23

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Syntocinon (Oxytocin, Product Code RVG 03716)Administration via nasal spray 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 spray0 / 220 / 222 / 22
Placebo (Physiological Water(Sodium Chloride (NaCl) Solution))Administration via nasal spray 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 spray0 / 180 / 183 / 18

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedIffland 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

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 40 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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)

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