Effect of intranasal oxytocin on the core social symptoms of autism spectrum disorder: a randomized clinical trial.

Yamasue H, Okada T, Munesue T, Kuroda M, Fujioka T, Uno Y, Matsumoto K, Kuwabara H, Mori D, Okamoto Y, Yoshimura Y, Kawakubo Y and 17 more

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Arioka Y, Kojima M, Yuhi T, Owada K, Yassin W, Kushima I, Benner S, Ogawa N, Eriguchi Y, Kawano N, Uemura Y, Yamamoto M, Kano Y, Kasai K, Higashida H, Ozaki N, Kosaka H

Molecular psychiatry29 Jun 2018Cited by 134 (Europe PMC)

PMID29955161DOI10.1038/s41380-018-0097-2PepBankPUB-29955161

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with autism spectrum disorder, intranasal oxytocin did not lower the ADOS reciprocity score more than placebo; the score fell in both groups.
In plain wordsIn adults with autism, oxytocin nasal spray did not improve social reciprocity more than placebo; scores fell in both groups.
Peptide
Oxytocin
Outcome
No significant changeADOS reciprocity score
Study
n = 103
Comparator
Placebo
Analysis
Primary
Outcome group
Autism core symptoms · Mental health and mood
Studied dose
48 IU/day · intranasal · 6 weeksAs given in this study (human).
Measurements
Effect size
−0.08 effect size
ADOS reciprocity, between groups
Source sentences
Summary
Since oxytocin reduced the primary endpoint, Autism Diagnostic Observation Schedule (ADOS) reciprocity, (from 8.5 to 7.7; P < .001) but placebo also reduced the score (8.3 to 7.2; P < .001), no between-group difference was found (effect size -0.08; 95% CI, -0.46 to 0.31; P = .69)
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomized, parallel-group, multicenter, placebo-controlled, double-blind trial in Japan, 106 ASD individuals (18-48 y.o.) were enrolled between Jan 2015 and March 2016.
Summary · context
Participants were randomly assigned to a 6-week intranasal oxytocin (48IU/day, n = 53) or placebo (n = 53) group.
Report a problemFND-2995516101
02HumanRandomized controlled trialEfficacy outcome
In adults with autism spectrum disorder, intranasal oxytocin reduced the ADOS repetitive behavior score compared with placebo.
In plain wordsIn adults with autism, oxytocin nasal spray reduced repetitive behavior scores more than placebo.
Peptide
Oxytocin
Outcome
DecreaseADOS repetitive behavior score
Study
n = 103
Comparator
Placebo
Analysis
Secondary
Outcome group
Autism core symptoms · Mental health and mood
Studied dose
48 IU/day · intranasal · 6 weeksAs given in this study (human).
Measurements
Effect size
0.44 effect size
ADOS repetitive behavior, between groups
Source sentences
Summary
Among the secondary endpoints, oxytocin reduced ADOS repetitive behavior (2.0 to 1.5; P < .0001) compared with placebo (2.0 to 1.8; P = .43) (effect size 0.44; 0.05 to 0.83; P = .026).
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomized, parallel-group, multicenter, placebo-controlled, double-blind trial in Japan, 106 ASD individuals (18-48 y.o.) were enrolled between Jan 2015 and March 2016.
Summary · context
Participants were randomly assigned to a 6-week intranasal oxytocin (48IU/day, n = 53) or placebo (n = 53) group.
Report a problemFND-2995516103
03HumanRandomized controlled trialEfficacy outcome
In adults with autism spectrum disorder, intranasal oxytocin increased gaze fixation duration on socially relevant regions compared with placebo.
In plain wordsIn adults with autism, oxytocin nasal spray increased time spent looking at socially relevant areas more than placebo.
Peptide
Oxytocin
Outcome
IncreaseDuration of gaze fixation on socially relevant regions
Study
n = 103
Comparator
Placebo
Analysis
Secondary
Outcome group
Social behavior and cognition · Mental health and mood
Studied dose
48 IU/day · intranasal · 6 weeksAs given in this study (human).
Measurements
Effect size
0.55 effect size
gaze fixation, between groups
Source sentences
Summary
In addition, the duration of gaze fixation on socially relevant regions, another secondary endpoint, was increased by oxytocin (41.2 to 52.3; P = .03) compared with placebo (45.7 to 40.4; P = .25) (effect size 0.55; 0.10 to 1.0; P = .018).
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomized, parallel-group, multicenter, placebo-controlled, double-blind trial in Japan, 106 ASD individuals (18-48 y.o.) were enrolled between Jan 2015 and March 2016.
Summary · context
Participants were randomly assigned to a 6-week intranasal oxytocin (48IU/day, n = 53) or placebo (n = 53) group.
Report a problemFND-2995516104
04HumanRandomized controlled trialEfficacy outcome
In adults with autism spectrum disorder, intranasal oxytocin had no significant effect on the other secondary endpoints.
In plain wordsIn adults with autism, oxytocin nasal spray had no significant effect on the other secondary measures.
Peptide
Oxytocin
Outcome
No significant changeOther secondary endpoints
Study
n = 103
Comparator
Placebo
Analysis
Secondary
Outcome group
Anxiety and mood · Mental health and mood
Studied dose
48 IU/day · intranasal · 6 weeksAs given in this study (human).
Source sentences
Summary
No significant effects were observed for the other secondary endpoints.
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomized, parallel-group, multicenter, placebo-controlled, double-blind trial in Japan, 106 ASD individuals (18-48 y.o.) were enrolled between Jan 2015 and March 2016.
Summary · context
Participants were randomly assigned to a 6-week intranasal oxytocin (48IU/day, n = 53) or placebo (n = 53) group.
Report a problemFND-2995516105
05HumanRandomized controlled trialSafety outcome
In adults with autism spectrum disorder, the prevalence of adverse events did not differ significantly between intranasal oxytocin and placebo.
In plain wordsIn adults with autism, side effects were not significantly more common with oxytocin nasal spray than with placebo.
Peptide
Oxytocin
Outcome
No significant changePrevalence of adverse events
Study
n = 106
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
48 IU/day · intranasal · 6 weeksAs given in this study (human).
Source sentences
Summary
No significant difference in the prevalence of adverse events was observed between groups
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomized, parallel-group, multicenter, placebo-controlled, double-blind trial in Japan, 106 ASD individuals (18-48 y.o.) were enrolled between Jan 2015 and March 2016.
Summary · context
Participants were randomly assigned to a 6-week intranasal oxytocin (48IU/day, n = 53) or placebo (n = 53) group.
Report a problemFND-2995516106
06HumanRandomized controlled trialPharmacokinetics
In adults with autism spectrum disorder, plasma oxytocin rose from baseline to endpoint only in the intranasal oxytocin group compared with placebo.
In plain wordsIn adults with autism, blood oxytocin rose only in the group given oxytocin nasal spray, not in the placebo group.
Peptide
Oxytocin
Outcome
IncreasePlasma oxytocin level
Study
n = 103
Comparator
Placebo
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
48 IU/day · intranasal · 6 weeksAs given in this study (human).
Measurements
Effect size
−1.12 effect size
plasma oxytocin, between groups
Source sentences
Summary
however, plasma oxytocin was only elevated from baseline to endpoint in the oxytocin-group compared with the placebo-group (effect size -1.12; -1.53 to -0.70; P < .0001).
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomized, parallel-group, multicenter, placebo-controlled, double-blind trial in Japan, 106 ASD individuals (18-48 y.o.) were enrolled between Jan 2015 and March 2016.
Summary · context
Participants were randomly assigned to a 6-week intranasal oxytocin (48IU/day, n = 53) or placebo (n = 53) group.
Report a problemFND-2995516102
07HumanRandomized controlled trialSafety outcome
In adults with autism spectrum disorder, one participant had temporary gynecomastia during intranasal oxytocin administration.
In plain wordsIn adults with autism, one person given oxytocin nasal spray had temporary breast enlargement.
Peptide
Oxytocin
Outcome
Not applicableTemporary gynecomastia
Study
n = 53
Outcome group
Adverse events · Endocrine and hormones
Studied dose
48 IU/day · intranasal · 6 weeksAs given in this study (human).
Source sentences
Summary
although one participant experienced temporary gynecomastia during oxytocin administration.
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomized, parallel-group, multicenter, placebo-controlled, double-blind trial in Japan, 106 ASD individuals (18-48 y.o.) were enrolled between Jan 2015 and March 2016.
Summary · context
Participants were randomly assigned to a 6-week intranasal oxytocin (48IU/day, n = 53) or placebo (n = 53) group.
Report a problemFND-2995516107

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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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