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Study · Randomized controlled trial · n = 31 · 2016

5 results

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

Yatawara CJ, Einfeld SL, Hickie IB, Davenport TA, Guastella AJ

Molecular psychiatry27 Oct 2015Cited by 265 (Europe PMC)

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: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study5

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

  1. 01HumanRandomized controlled trialEfficacy outcome

    In young children with autism, oxytocin nasal spray significantly improved caregiver-rated social responsiveness, the primary outcome, compared with placebo.

    In plain wordsIn young children with autism, oxytocin nasal spray improved caregiver-rated social responsiveness more than placebo did.

    Peptide
    Oxytocin
    Outcome
    Direction not reportedCaregiver-rated social responsiveness
    Study

    n = 31

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Social behavior and cognition · Mental health and mood
    Studied dose
    12 IU twice daily (24 IU per day) · intranasal · 5 weeksAs given in this study (human).

    Source sentences

    Summary
    Compared with placebo, oxytocin led to significant improvements on the primary outcome of caregiver-rated social responsiveness.
    1 context sentence
    Summary · context
    Thirty-one children with autism received 12 International Units (IU) of oxytocin and placebo nasal spray morning and night (24 IU per day) for 5 weeks, with a 4-week washout period between each treatment.
  2. 02HumanRandomized controlled trialSafety outcome

    In young children with autism, oxytocin nasal spray was well tolerated overall.

    In plain wordsIn young children with autism, oxytocin nasal spray was generally well tolerated.

    Peptide
    Oxytocin
    Outcome
    Not applicableOverall tolerability
    Study

    n = 31

    Outcome group
    Adverse events · Whole body
    Studied dose
    12 IU twice daily (24 IU per day) · intranasal · 5 weeksAs given in this study (human).

    Source sentences

    Summary
    Overall, nasal spray was well tolerated
    1 context sentence
    Summary · context
    Thirty-one children with autism received 12 International Units (IU) of oxytocin and placebo nasal spray morning and night (24 IU per day) for 5 weeks, with a 4-week washout period between each treatment.
  3. 03HumanRandomized controlled trialSafety outcome

    In young children with autism, thirst was among the most common adverse events with oxytocin nasal spray.

    In plain wordsIn young children with autism, thirst was one of the most common side effects of oxytocin nasal spray.

    Peptide
    Oxytocin
    Outcome
    Direction not reportedThirst as adverse event
    Study

    n = 31

    Outcome group
    Adverse events · Whole body
    Studied dose
    12 IU twice daily (24 IU per day) · intranasal · 5 weeksAs given in this study (human).

    Source sentences

    Summary
    Overall, nasal spray was well tolerated, and the most common reported adverse events were thirst, urination and constipation.
    1 context sentence
    Summary · context
    Thirty-one children with autism received 12 International Units (IU) of oxytocin and placebo nasal spray morning and night (24 IU per day) for 5 weeks, with a 4-week washout period between each treatment.
  4. 04HumanRandomized controlled trialSafety outcome

    In young children with autism, urination was among the most common adverse events reported with oxytocin nasal spray.

    In plain wordsIn young children with autism, urination was one of the most common side effects reported with oxytocin nasal spray.

    Peptide
    Oxytocin
    Outcome
    Direction not reportedUrination as adverse event
    Study

    n = 31

    Outcome group
    Adverse events · Whole body
    Studied dose
    12 IU twice daily (24 IU per day) · intranasal · 5 weeksAs given in this study (human).

    Source sentences

    Summary
    Overall, nasal spray was well tolerated, and the most common reported adverse events were thirst, urination and constipation.
    1 context sentence
    Summary · context
    Thirty-one children with autism received 12 International Units (IU) of oxytocin and placebo nasal spray morning and night (24 IU per day) for 5 weeks, with a 4-week washout period between each treatment.
  5. 05HumanRandomized controlled trialSafety outcome

    In young children with autism, constipation was among the most common adverse events with oxytocin nasal spray.

    In plain wordsIn young children with autism, constipation was one of the most common side effects of oxytocin nasal spray.

    Peptide
    Oxytocin
    Outcome
    Direction not reportedConstipation as adverse event
    Study

    n = 31

    Outcome group
    Adverse events · Whole body
    Studied dose
    12 IU twice daily (24 IU per day) · intranasal · 5 weeksAs given in this study (human).

    Source sentences

    Summary
    Overall, nasal spray was well tolerated, and the most common reported adverse events were thirst, urination and constipation.
    1 context sentence
    Summary · context
    Thirty-one children with autism received 12 International Units (IU) of oxytocin and placebo nasal spray morning and night (24 IU per day) for 5 weeks, with a 4-week washout period between each treatment.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedNot applicableNCT03114371

Oxytocin Intranasal Administrations in Children With Prader-Willi Syndrome Aged From 3 to 12 Years

University Hospital, Toulousen = 4028 Nov 2016 to 11 Jan 2019

Prader-Willi Syndrome

Trial pageClinicalTrials.govUpdated 12 Nov 2020

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    11 Oct 2026, 01:30 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 02:49 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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