Autism Spectrum DisordersPhase 4NCT02940574

Neural and Behavioral Effects of Oxytocin in Autism Spectrum Disorders

A Phase 4 study testing Syntocinon (Oxytocin) in people with Autism Spectrum Disorders, run by KU Leuven.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 40 years, men only
Conditions the study is for: Autism Spectrum Disorders
What is being tested?: Syntocinon (Oxytocin)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: No sites listed yet
Study dates: Apr 2015to Dec 2019
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
Men only
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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)

About this study

Official title: Oxytocin-based Pharmacotherapy for Autism Spectrum Disorders: Investigating the Neural and Behavioral Effects of a Promising Intervention Approach

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.

Read the 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
Being tested: Syntocinon (Oxytocin), Placebo (Physiological water (solution of sodium chloride (NaCl) in water))
Keywords: Oxytocin, Autism Spectrum Disorders
Medical subject headings: Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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
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

Study groups in NCT02940574
Study group	Role	What they receive
Syntocinon (Oxytocin, product code RVG 03716)	Experimental	Administration via nasal spray Receives: Drug: Syntocinon (Oxytocin)
Placebo (Physiological water(sodium chloride (NaCl) solution))	Placebo comparator	Administration via nasal spray Receives: Other: Placebo (Physiological water (solution of sodium chloride (NaCl) in water))

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
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.
Measured: Value at 4 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 8 Weeks, Including 4 Weeks Without Nasal Spray
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.
Measured: Value at 8 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 52 Weeks, Including 48 Weeks Without Nasal Spray
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.
Measured: Value at 52 weeks minus value at baseline
Change From Baseline in Scores on Questionnaire Assessing Mood After a Single Dose of Nasal Spray
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.
Measured: Value at 30 minutes minus value at baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2015Dec 2019

First posted21 Oct 2016 (estimated)
Study startApr 2015
Primary completionDec 2016
Study completionDec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
More trials run by KU LeuvenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02940574
Sponsor's protocol ID: S56327
Other IDs: 2014-000586-45, 2014
Status last verified: Jan 2021
First submitted: 19 Oct 2016
Last updated: 10 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 37811711

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Autism Spectrum Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Oxytocin-based Pharmacotherapy for Autism Spectrum Disorders: Investigating the Neural and Behavioral Effects of a Promising Intervention Approach
ClinicalTrials.gov ID: NCT02940574
Acronym / sponsor ID: S56327
Conditions: Autism Spectrum Disorders
Keywords: Oxytocin, Autism Spectrum Disorders
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: KU LeuvenUniversity, hospital or other
Collaborators: The Branco Weiss Fellowship, Research Foundation Flanders
Study start: Apr 2015 (actual)
Primary completion: Dec 2016 (actual)
Study completion: Dec 2019 (actual)
First posted: 21 Oct 2016 (estimated)
Results: Posted 13 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Syntocinon (Oxytocin, product code RVG 03716)	Experimental	Drug: Syntocinon (Oxytocin)Administration via nasal spray
Placebo (Physiological water(sodium chloride (NaCl) solution))	Placebo comparator	Other: Placebo (Physiological water (solution of sodium chloride (NaCl) in water))Administration via nasal spray

Who may qualify

Ages: 18 to 40 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (7 listed)

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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Drug	Syntocinon (Oxytocin, product code RVG 03716)
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	Other	Placebo (Physiological water(sodium chloride (NaCl) solution))

Primary outcome

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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)

8 secondary outcomes

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
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
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
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
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
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
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
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

Results and safety

Results posted to the registry on 13 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Syntocinon (Oxytocin, Product Code RVG 03716)	22	21
Placebo (Physiological Water(Sodium Chloride (NaCl) Solution))	18	18

Primary outcome: 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. Mean (Standard Deviation). Unit: Change-from-baseline (BOLD response)

Measure	Syntocinon (Oxytocin, Product Code RVG 03716) n = 21	Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) n = 17
Brain activity - Superior temporal sulcus	0.11 (0.49)	-0.26 (0.72)
Brain activity - Amygdala	-0.15 (0.50)	-0.16 (0.58)

Population analysed: 1 subject lost in Syntocinon group due to subject withdrawal. 1 subject lost in Placebo group due to low data quality (excessive in-scanner head motion)

Primary outcome: 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. Mean (Standard Deviation). Unit: Change-from-baseline (BOLD response)

Measure	Syntocinon (Oxytocin, Product Code RVG 03716) n = 21	Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) n = 17
Brain activity - Superior temporal sulcus	-0.10 (0.59)	-0.29 (0.68)
Brain activity - Amygdala	-0.09 (0.46)	0.06 (0.45)

Population analysed: 1 subject lost in Syntocinon group due to subject withdrawal. 1 subject lost in Placebo group due to low data quality (excessive in-scanner head motion)

Primary outcome: 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. Mean (Standard Deviation). Unit: Change-from-baseline (BOLD response)

Measure	Syntocinon (Oxytocin, Product Code RVG 03716) n = 21	Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) n = 17
Brain activity - Superior temporal sulcus	-0.21 (0.58)	-0.16 (0.66)
Brain activity - Amygdala	-0.18 (0.52)	0.04 (0.56)

Population analysed: 1 subject lost in Syntocinon group due to subject withdrawal. 1 subject lost in Placebo group due to low data quality (excessive in-scanner head motion)

Primary outcome: 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. Mean (Standard Deviation). Unit: Change-from-baseline (BOLD response)

Measure	Syntocinon (Oxytocin, Product Code RVG 03716) n = 18	Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) n = 14
Brain activity - Superior temporal sulcus	-0.18 (0.56)	-0.48 (0.73)
Brain activity - Amygdala	-0.21 (0.51)	0.03 (0.40)

Population analysed: 1 subject lost in Syntocinon group due to subject withdrawal. (+ 3 additional participants lost for 1-year follow-up) 1 subject lost in Placebo group due to low data quality (excessive in-scanner head motion) (+ 3 additional participants lost for 1-year follow-up)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected over a period of (approximately) four weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Syntocinon (Oxytocin, Product Code RVG 03716)	0 of 22 (0%)	2 of 22 (9.1%)	0 of 22
Placebo (Physiological Water(Sodium Chloride (NaCl) Solution))	0 of 18 (0%)	3 of 18 (16.7%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37811711Iffland 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kaat Alaerts, PhD principal investigator

KU Leuven

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Syntocinon (Oxytocin) in people with Autism Spectrum Disorders, run by KU Leuven.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02940574, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.