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Study · Non-randomized trial · n = 8 · 2013

6 results

Long-term administration of intranasal oxytocin is a safe and promising therapy for early adolescent boys with autism spectrum disorders.

Tachibana M, Kagitani-Shimono K, Mohri I, Yamamoto T, Sanefuji W, Nakamura A, Oishi M, Kimura T, Onaka T, Ozono K, Taniike M

Journal of child and adolescent psychopharmacology12 Mar 2013Cited by 120 (Europe PMC)

PMID23480321 (opens in a new tab)DOI10.1089/cap.2012.0048 (opens in a new tab)PepBankPUB-23480321
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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 study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanNon-randomized trialEfficacy outcome

    In eight boys with autism spectrum disorder, six of eight showed improved scores on the communication and social interaction domains of the ADOS-G during long-term intranasal oxytocin.

    In plain wordsIn eight boys with autism, six showed better communication and social interaction scores during long-term oxytocin. There was no control group.

    Peptide
    Oxytocin
    Outcome
    Not applicableADOS-G communication and social interaction scores
    Study

    n = 8

    Outcome group
    Autism core symptoms · Mental health and mood
    Studied dose
    8, 16, 24 IU per dose, stepwise every 2 months · intranasalAs given in this study (human).

    Source sentences

    Summary
    Six of the eight participants showed improved scores on the communication and social interaction domains of the ADOS-G.
    3 context sentences
    Summary · context
    We conducted a singled-armed, open-label study in which OT was administered intranasally over the long term to eight male youth with ASD (10-14 years of age; intelligence quotient [IQ] 20-101).
    Summary · context
    The OT administration was performed in a stepwise increased dosage manner every 2 months (8, 16, 24 IU/dose).
    Summary · context
    A placebo period (1-2 weeks) was inserted before each step.
  2. 02HumanNon-randomized trialEfficacy outcome

    In eight boys with autism spectrum disorder, CBCL T-scores showed no statistically significant improvement during oxytocin treatment.

    In plain wordsIn eight boys with autism, behaviour checklist scores did not improve by a statistically significant amount during oxytocin.

    Peptide
    Oxytocin
    Outcome
    No significant changeCBCL T-scores
    Study

    n = 8

    Outcome group
    Anxiety and mood · Mental health and mood
    Studied dose
    8, 16, 24 IU per dose, stepwise every 2 months · intranasalAs given in this study (human).

    Source sentences

    Summary
    regarding the T-scores of the CBCL and the scores of the ABC, we could not find any statistically significant improvement
    3 context sentences
    Summary · context
    We conducted a singled-armed, open-label study in which OT was administered intranasally over the long term to eight male youth with ASD (10-14 years of age; intelligence quotient [IQ] 20-101).
    Summary · context
    The OT administration was performed in a stepwise increased dosage manner every 2 months (8, 16, 24 IU/dose).
    Summary · context
    A placebo period (1-2 weeks) was inserted before each step.
  3. 03HumanNon-randomized trialEfficacy outcome

    In eight boys with autism spectrum disorder, aberrant behavior checklist scores showed no statistically significant improvement, although some subcategories showed a mild tendency to improve.

    In plain wordsIn eight boys with autism, aberrant behaviour scores did not improve by a statistically significant amount during oxytocin.

    Peptide
    Oxytocin
    Outcome
    No significant changeABC scores
    Study

    n = 8

    Outcome group
    Anxiety and mood · Mental health and mood
    Studied dose
    8, 16, 24 IU per dose, stepwise every 2 months · intranasalAs given in this study (human).

    Source sentences

    Summary
    regarding the T-scores of the CBCL and the scores of the ABC, we could not find any statistically significant improvement, although several subcategories showed a mild tendency for improvement.
    3 context sentences
    Summary · context
    We conducted a singled-armed, open-label study in which OT was administered intranasally over the long term to eight male youth with ASD (10-14 years of age; intelligence quotient [IQ] 20-101).
    Summary · context
    The OT administration was performed in a stepwise increased dosage manner every 2 months (8, 16, 24 IU/dose).
    Summary · context
    A placebo period (1-2 weeks) was inserted before each step.
  4. 04HumanNon-randomized trialEfficacy outcome

    Caregivers of five of the eight boys reported certain positive effects of oxytocin therapy, especially on the quality of reciprocal communication.

    In plain wordsCaregivers of five of eight boys with autism reported positive effects of oxytocin, mainly on two-way communication. There was no control group.

    Peptide
    Oxytocin
    Outcome
    Not applicableCaregiver-reported positive effects
    Study

    n = 8

    Outcome group
    Social behavior and cognition · Mental health and mood
    Studied dose
    8, 16, 24 IU per dose, stepwise every 2 months · intranasalAs given in this study (human).

    Source sentences

    Summary
    Caregivers of five of the eight participants reported certain positive effects of the OT therapy, especially on the quality of reciprocal communication.
    3 context sentences
    Summary · context
    We conducted a singled-armed, open-label study in which OT was administered intranasally over the long term to eight male youth with ASD (10-14 years of age; intelligence quotient [IQ] 20-101).
    Summary · context
    The OT administration was performed in a stepwise increased dosage manner every 2 months (8, 16, 24 IU/dose).
    Summary · context
    A placebo period (1-2 weeks) was inserted before each step.
  5. 05HumanNon-randomized trialSafety outcome

    In eight boys with autism spectrum disorder, no side effects were observed during long-term intranasal oxytocin.

    In plain wordsIn eight boys with autism, no side effects were seen during long-term oxytocin. The group was very small.

    Peptide
    Oxytocin
    Outcome
    No significant changeSide effects
    Study

    n = 8

    Outcome group
    Adverse events · Mental health and mood
    Studied dose
    8, 16, 24 IU per dose, stepwise every 2 months · intranasalAs given in this study (human).

    Source sentences

    Summary
    All participants showed excellent compliance and no side effects.
    4 context sentences
    Summary · context
    In addition, side effects were monitored by measuring blood pressure and examining urine and blood samples.
    Summary · context
    We conducted a singled-armed, open-label study in which OT was administered intranasally over the long term to eight male youth with ASD (10-14 years of age; intelligence quotient [IQ] 20-101).
    Summary · context
    The OT administration was performed in a stepwise increased dosage manner every 2 months (8, 16, 24 IU/dose).
    Summary · context
    A placebo period (1-2 weeks) was inserted before each step.
  6. 06HumanNon-randomized trialOther

    All eight boys showed excellent compliance with long-term intranasal oxytocin.

    In plain wordsAll eight boys with autism took the oxytocin treatment as planned.

    Peptide
    Oxytocin
    Outcome
    Not applicableCompliance
    Study

    n = 8

    Outcome group
    Adverse events · Mental health and mood
    Studied dose
    8, 16, 24 IU per dose, stepwise every 2 months · intranasalAs given in this study (human).

    Source sentences

    Summary
    All participants showed excellent compliance and no side effects.
    3 context sentences
    Summary · context
    We conducted a singled-armed, open-label study in which OT was administered intranasally over the long term to eight male youth with ASD (10-14 years of age; intelligence quotient [IQ] 20-101).
    Summary · context
    The OT administration was performed in a stepwise increased dosage manner every 2 months (8, 16, 24 IU/dose).
    Summary · context
    A placebo period (1-2 weeks) was inserted before each step.

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 stopped early · source ClinicalTrials.gov (opens in a new tab)

TerminatedPhase 2/3NCT02007447

Oxytocin in Adolescents With Autism Spectrum Disorders

University of Sao Paulo General Hospitaln = 30Jun 2015 to 4 May 2018

Autism Spectrum Disorder

Trial pageClinicalTrials.govUpdated 28 Oct 2019

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, 02:51 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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