Effects of multiple-dose intranasal oxytocin administration on social responsiveness in children with autism: a randomized, placebo-controlled trial.

Daniels N, Moerkerke M, Steyaert J, Bamps A, Debbaut E, Prinsen J, Tang T, Van der Donck S, Boets B, Alaerts K

Molecular autism20 Apr 2023Cited by 49 (Europe PMC)

PMID37081454PMCIDPMC10117268DOI10.1186/s13229-023-00546-5PepBankPUB-37081454

Summary

BackgroundIntranasal administration of oxytocin is increasingly explored as a new approach to facilitate social development and reduce disability associated with a diagnosis of autism spectrum disorder (ASD). The efficacy of multiple-dose oxytocin administration in children with ASD is, however, not well established.MethodsA double-blind, randomized, placebo-controlled trial with parallel design explored the effects of a 4-week intranasal oxytocin administration (12 IU, twice daily) on parent-rated social responsiveness (Social Responsiveness Scale: SRS-2) in pre-pubertal school-aged children (aged 8-12 years, 61 boys, 16 girls). Secondary outcomes included a questionnaire-based assessment of repetitive behaviors, anxiety, and attachment. Effects of oxytocin were assessed immediately after the administration period and at a follow-up, 4 weeks after the last administration. The double-blind phase was followed by a 4-week single-blind phase during which all participants received intranasal oxytocin.ResultsIn the double-blind phase, both the oxytocin and placebo group displayed significant pre-to-post-improvements in social responsiveness and secondary questionnaires, but improvements were not specific to the intranasal oxytocin. Notably, in the single-blind phase, participants who were first allocated to intranasal placebo and later changed to intranasal oxytocin displayed a significant improvement in social responsiveness, over and above the placebo-induced improvements noted in the first phase. Participants receiving oxytocin in the first phase also showed a significant further improvement upon receiving a second course of oxytocin, but only at the 4-week follow-up. Further, exploratory moderator analyses indicated that children who received psychosocial trainings (3 or more sessions per month) along with oxytocin administration displayed a more pronounced improvement in social responsiveness.LimitationsFuture studies using larger cohorts and more explicitly controlled concurrent psychosocial trainings are warranted to further explore the preliminary moderator effects, also including understudied populations within the autism spectrum, such as children with co-occurring intellectual disabilities.ConclusionsFour weeks of oxytocin administration did not induce treatment-specific improvements in social responsiveness in school-aged children with ASD. Future studies are warranted to further explore the clinical efficacy of oxytocin administration paired with targeted psychosocial trainings that stimulate socio-communicative behaviors. Trial registration The trial was registered with the European Clinical Trial Registry (EudraCT 2018-000769-35) on June 7th, 2018 ( https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-000769-35/BE ).

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 with autism, both oxytocin and placebo groups improved on secondary questionnaires, and the improvements were not specific to oxytocin.
In plain wordsIn children with autism, secondary questionnaire scores improved in both groups, so the gains were not specific to oxytocin.
Peptide
Oxytocin
Outcome
No significant changeSecondary questionnaires (repetitive behaviors, anxiety, attachment), double-blind phase
Study
n = 77
Comparator
Placebo
Analysis
Secondary
Outcome group
Anxiety and mood · Mental health and mood
Studied dose
12 IU twice daily · intranasal · 4 weeksAs given in this study (human).
Source sentences
Summary
In the double-blind phase, both the oxytocin and placebo group displayed significant pre-to-post-improvements in social responsiveness and secondary questionnaires, but improvements were not specific to the intranasal oxytocin.
2 context sentences(design, population, supporting numbers)
Summary · context
Secondary outcomes included a questionnaire-based assessment of repetitive behaviors, anxiety, and attachment.
Summary · context
A double-blind, randomized, placebo-controlled trial with parallel design explored the effects of a 4-week intranasal oxytocin administration (12 IU, twice daily) on parent-rated social responsiveness (Social Responsiveness Scale: SRS-2) in pre-pubertal school-aged children (aged 8-12 years, 61 boys, 16 girls).
Show in the study text Report a problemFND-3708145402
02HumanRandomized controlled trialEfficacy outcome
In an exploratory analysis in children with autism, those with three or more psychosocial training sessions per month alongside oxytocin showed more improvement in social responsiveness.
In plain wordsIn an exploratory analysis, children with autism who also had frequent psychosocial training showed more improvement in social responsiveness with oxytocin.
Peptide
Oxytocin
Outcome
IncreaseSocial responsiveness by psychosocial training (moderator analysis)
Study
n: not reported in source
Analysis
Exploratory
Outcome group
Social behavior and cognition · Nervous system and cognition
Studied dose
12 IU twice daily · intranasal · 4 weeksAs given in this study (human).
Source sentences
Summary
Further, exploratory moderator analyses indicated that children who received psychosocial trainings (3 or more sessions per month) along with oxytocin administration displayed a more pronounced improvement in social responsiveness.
1 context sentence(design, population, supporting numbers)
Summary · context
A double-blind, randomized, placebo-controlled trial with parallel design explored the effects of a 4-week intranasal oxytocin administration (12 IU, twice daily) on parent-rated social responsiveness (Social Responsiveness Scale: SRS-2) in pre-pubertal school-aged children (aged 8-12 years, 61 boys, 16 girls).
Show in the study text Report a problemFND-3708145405
03HumanRandomized controlled trialEfficacy outcome
In children with autism, four weeks of intranasal oxytocin did not improve social responsiveness more than placebo; both groups improved.
In plain wordsIn children with autism, oxytocin nasal spray did not improve social responsiveness more than placebo; both groups improved.
Peptide
Oxytocin
Outcome
No significant changeParent-rated social responsiveness (SRS-2), double-blind phase
Study
n = 77
Comparator
Placebo
Outcome group
Social behavior and cognition · Nervous system and cognition
Studied dose
12 IU twice daily · intranasal · 4 weeksAs given in this study (human).
Source sentences
Summary
In the double-blind phase, both the oxytocin and placebo group displayed significant pre-to-post-improvements in social responsiveness and secondary questionnaires, but improvements were not specific to the intranasal oxytocin.
2 context sentences(design, population, supporting numbers)
Summary · context
Four weeks of oxytocin administration did not induce treatment-specific improvements in social responsiveness in school-aged children with ASD.
Summary · context
A double-blind, randomized, placebo-controlled trial with parallel design explored the effects of a 4-week intranasal oxytocin administration (12 IU, twice daily) on parent-rated social responsiveness (Social Responsiveness Scale: SRS-2) in pre-pubertal school-aged children (aged 8-12 years, 61 boys, 16 girls).
Show in the study text Report a problemFND-3708145401
04HumanNon-randomized trialEfficacy outcome
In children with autism first given placebo, switching to intranasal oxytocin in the single-blind phase gave a significant further improvement in social responsiveness.
In plain wordsIn children with autism who first got placebo, switching to oxytocin brought further improvement in social responsiveness, in a phase where everyone received oxytocin.
Peptide
Oxytocin
Outcome
IncreaseSocial responsiveness after switch from placebo to oxytocin (single-blind phase)
Study
n: not reported in source
Comparator
Placebo-induced improvement in first phase
Outcome group
Social behavior and cognition · Nervous system and cognition
Studied dose
Dose not stated · intranasal · 4 weeksAs given in this study (human).
Source sentences
Summary
Notably, in the single-blind phase, participants who were first allocated to intranasal placebo and later changed to intranasal oxytocin displayed a significant improvement in social responsiveness, over and above the placebo-induced improvements noted in the first phase.
1 context sentence(design, population, supporting numbers)
Summary · context
A double-blind, randomized, placebo-controlled trial with parallel design explored the effects of a 4-week intranasal oxytocin administration (12 IU, twice daily) on parent-rated social responsiveness (Social Responsiveness Scale: SRS-2) in pre-pubertal school-aged children (aged 8-12 years, 61 boys, 16 girls).
Show in the study text Report a problemFND-3708145403
05HumanNon-randomized trialEfficacy outcome
In children with autism first given oxytocin, a second oxytocin course gave a significant further improvement in social responsiveness, but only at the 4-week follow-up.
In plain wordsIn children with autism who got oxytocin first, a second course brought further improvement, but only at the 4-week follow-up.
Peptide
Oxytocin
Outcome
IncreaseSocial responsiveness after second oxytocin course (single-blind phase)
Study
n: not reported in source
Comparator
Improvement after first oxytocin course
Outcome group
Social behavior and cognition · Nervous system and cognition
Studied dose
Dose not stated · intranasal · 4 weeksAs given in this study (human).
Source sentences
Summary
Participants receiving oxytocin in the first phase also showed a significant further improvement upon receiving a second course of oxytocin, but only at the 4-week follow-up.
1 context sentence(design, population, supporting numbers)
Summary · context
A double-blind, randomized, placebo-controlled trial with parallel design explored the effects of a 4-week intranasal oxytocin administration (12 IU, twice daily) on parent-rated social responsiveness (Social Responsiveness Scale: SRS-2) in pre-pubertal school-aged children (aged 8-12 years, 61 boys, 16 girls).
Show in the study text Report a problemFND-3708145404

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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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