The effect of oxytocin nasal spray on social interaction in young children with autism: a randomized clinical trial.

Guastella AJ, Boulton KA, Whitehouse AJO, Song YJ, Thapa R, Gregory SG, Pokorski I, Granich J, DeMayo MM, Ambarchi Z, Wray J, Thomas EE, Hickie IB

Molecular psychiatry27 Oct 2022Cited by 57 (Europe PMC)

PMID36302965PMCIDPMC9607840DOI10.1038/s41380-022-01845-8PepBankPUB-36302965

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Summary

Early supports to enhance social development in children with autism are widely promoted. While oxytocin has a crucial role in mammalian social development, its potential role as a medication to enhance social development in humans remains unclear. We investigated the efficacy, tolerability, and safety of intranasal oxytocin in young children with autism using a double-blind, randomized, placebo-controlled, clinical trial, following a placebo lead-in phase. A total of 87 children (aged between 3 and 12 years) with autism received 16 International Units (IU) of oxytocin (n = 45) or placebo (n = 42) nasal spray, morning and night (32 IU per day) for twelve weeks, following a 3-week placebo lead-in phase. Overall, there was no effect of oxytocin treatment over time on the caregiver-rated Social Responsiveness Scale (SRS-2) (p = 0.686). However, a significant interaction with age (p = 0.028) showed that for younger children, aged 3-5 years, there was some indication of a treatment effect. Younger children who received oxytocin showed improvement on caregiver-rated social responsiveness ( SRS-2). There was no other evidence of benefit in the sample as a whole, or in the younger age group, on the clinician-rated Clinical Global Improvement Scale (CGI-S), or any secondary measure. Importantly, placebo effects in the lead-in phase were evident and there was support for washout of the placebo response in the randomised phase. Oxytocin was well tolerated, with more adverse side effects reported in the placebo group. This study suggests the need for further clinical trials to test the benefits of oxytocin treatment in younger populations with autism.Trial registration www.anzctr.org.au (ACTRN12617000441314).

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialEfficacy outcome
In children aged 3 to 12 years with autism, intranasal oxytocin had no effect over time on caregiver-rated SRS-2 compared with placebo.
In plain wordsIn children with autism, oxytocin nasal spray did not change caregiver-rated social responsiveness over time compared with placebo.
Peptide
Oxytocin
Outcome
No significant changeCaregiver-rated SRS-2 over time, all children
Study
n = 87
Comparator
Placebo
Outcome group
Social behavior and cognition · Nervous system and cognition
Studied dose
16 IU morning and night (32 IU per day) · intranasal · 12 weeksAs given in this study (human).
Source sentences
Summary
Overall, there was no effect of oxytocin treatment over time on the caregiver-rated Social Responsiveness Scale (SRS-2) (p = 0.686).
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 87 children (aged between 3 and 12 years) with autism received 16 International Units (IU) of oxytocin (n = 45) or placebo (n = 42) nasal spray, morning and night (32 IU per day) for twelve weeks, following a 3-week placebo lead-in phase.
Show in the study text Report a problemFND-3630296501
02HumanRandomized controlled trialSafety outcome
In children with autism, intranasal oxytocin was well tolerated.
In plain wordsIn children with autism, oxytocin nasal spray was well tolerated.
Peptide
Oxytocin
Outcome
No significant changeTolerability
Study
n = 87
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
16 IU morning and night (32 IU per day) · intranasal · 12 weeksAs given in this study (human).
Source sentences
Summary
Oxytocin was well tolerated
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 87 children (aged between 3 and 12 years) with autism received 16 International Units (IU) of oxytocin (n = 45) or placebo (n = 42) nasal spray, morning and night (32 IU per day) for twelve weeks, following a 3-week placebo lead-in phase.
Show in the study text Report a problemFND-3630296505
03HumanRandomized controlled trialEfficacy outcome
In children with autism aged 3 to 5 years, oxytocin showed some indication of a treatment effect on caregiver-rated SRS-2, with a significant age interaction.
In plain wordsIn younger children with autism, oxytocin showed some sign of better caregiver-rated social responsiveness than placebo.
Peptide
Oxytocin
Outcome
Direction not reportedCaregiver-rated SRS-2 in children aged 3-5 years
Study
n: not reported in source
Comparator
Placebo
Outcome group
Social behavior and cognition · Nervous system and cognition
Studied dose
16 IU morning and night (32 IU per day) · intranasal · 12 weeksAs given in this study (human).
Source sentences
Summary
However, a significant interaction with age (p = 0.028) showed that for younger children, aged 3-5 years, there was some indication of a treatment effect. Younger children who received oxytocin showed improvement on caregiver-rated social responsiveness ( SRS-2).
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 87 children (aged between 3 and 12 years) with autism received 16 International Units (IU) of oxytocin (n = 45) or placebo (n = 42) nasal spray, morning and night (32 IU per day) for twelve weeks, following a 3-week placebo lead-in phase.
Show in the study text Report a problemFND-3630296502
04HumanRandomized controlled trialEfficacy outcome
In children with autism, oxytocin showed no benefit on the clinician-rated CGI-S in the whole sample or in the younger age group.
In plain wordsIn children with autism, oxytocin did not improve the clinician-rated global score compared with placebo.
Peptide
Oxytocin
Outcome
No significant changeClinician-rated CGI-S
Study
n: not reported in source
Comparator
Placebo
Outcome group
Social behavior and cognition · Nervous system and cognition
Studied dose
16 IU morning and night (32 IU per day) · intranasal · 12 weeksAs given in this study (human).
Source sentences
Summary
There was no other evidence of benefit in the sample as a whole, or in the younger age group, on the clinician-rated Clinical Global Improvement Scale (CGI-S), or any secondary measure.
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 87 children (aged between 3 and 12 years) with autism received 16 International Units (IU) of oxytocin (n = 45) or placebo (n = 42) nasal spray, morning and night (32 IU per day) for twelve weeks, following a 3-week placebo lead-in phase.
Show in the study text Report a problemFND-3630296503
05HumanRandomized controlled trialEfficacy outcome
In children with autism, oxytocin showed no benefit on any secondary measure in the whole sample or in the younger age group.
In plain wordsIn children with autism, oxytocin did not improve any secondary measure compared with placebo.
Peptide
Oxytocin
Outcome
No significant changeSecondary measures
Study
n: not reported in source
Comparator
Placebo
Outcome group
Social behavior and cognition · Nervous system and cognition
Studied dose
16 IU morning and night (32 IU per day) · intranasal · 12 weeksAs given in this study (human).
Source sentences
Summary
There was no other evidence of benefit in the sample as a whole, or in the younger age group, on the clinician-rated Clinical Global Improvement Scale (CGI-S), or any secondary measure.
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 87 children (aged between 3 and 12 years) with autism received 16 International Units (IU) of oxytocin (n = 45) or placebo (n = 42) nasal spray, morning and night (32 IU per day) for twelve weeks, following a 3-week placebo lead-in phase.
Show in the study text Report a problemFND-3630296504

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Version history

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Version 2Current
11 Oct 2026, 00:50 UTC
Study results updated
Version 1
9 Oct 2026, 02:48 UTC
First added · source update from Europe PMC

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