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Study · Randomized controlled trial · n = 79 · 2024

4 results

Chronic oxytocin administration stimulates the oxytocinergic system in children with autism.

Moerkerke M, Daniels N, Tibermont L, Tang T, Evenepoel M, Van der Donck S, Debbaut E, Prinsen J, Chubar V, Claes S, Vanaudenaerde B, Willems L, Steyaert J, Boets B, Alaerts K

Nature communications2 Jan 2024Cited by 35 (Europe PMC)

Summary

Clinical efficacy of intranasal administration of oxytocin is increasingly explored in autism spectrum disorder, but to date, the biological effects of chronic administration regimes on endogenous oxytocinergic function are largely unknown. Here exploratory biological assessments from a completed randomized, placebo-controlled trial showed that children with autism (n = 79, 16 females) receiving intranasal oxytocin for four weeks (12 IU, twice daily) displayed significantly higher salivary oxytocin levels 24 hours after the last oxytocin nasal spray administration, but no longer at a four-week follow up session. Regarding salivary oxytocin receptor gene (OXTR) epigenetics (DNA-methylation), oxytocin-induced reductions in OXTR DNA-methylation were observed, suggesting a facilitation of oxytocin receptor expression in the oxytocin compared to the placebo group. Notably, heightened oxytocin levels post-treatment were significantly associated with reduced OXTR DNA-methylation and improved feelings of secure attachment. These findings indicate that four weeks of chronic oxytocin administration stimulated the endogenous oxytocinergic system in children with autism.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanRandomized controlled trialPharmacokinetics

    In children with autism, four weeks of intranasal oxytocin raised salivary oxytocin 24 hours after the last dose compared with placebo.

    In plain wordsIn children with autism, four weeks of nasal oxytocin led to higher oxytocin in saliva a day after the last dose than placebo.

    Peptide
    Oxytocin
    Outcome
    IncreaseSalivary oxytocin 24 hours after last dose
    Study

    n = 79

    Comparator
    Placebo
    Analysis
    Exploratory
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    12 IU twice daily · intranasal · four weeksAs given in this study (human).

    Source sentences

    Summary
    displayed significantly higher salivary oxytocin levels 24 hours after the last oxytocin nasal spray administration
    1 context sentence
    Summary · context
    children with autism (n = 79, 16 females) receiving intranasal oxytocin for four weeks (12 IU, twice daily)
  2. 02HumanRandomized controlled trialPharmacokinetics

    In children with autism, salivary oxytocin was no longer higher with oxytocin than with placebo at the four-week follow-up.

    In plain wordsIn children with autism, saliva oxytocin was no longer higher than with placebo four weeks after treatment ended.

    Peptide
    Oxytocin
    Outcome
    No significant changeSalivary oxytocin at four-week follow-up
    Study

    n = 79

    Comparator
    Placebo
    Analysis
    Exploratory
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    12 IU twice daily · intranasal · four weeksAs given in this study (human).

    Source sentences

    Summary
    but no longer at a four-week follow up session.
    1 context sentence
    Summary · context
    children with autism (n = 79, 16 females) receiving intranasal oxytocin for four weeks (12 IU, twice daily)
  3. 03HumanRandomized controlled trialMechanism

    In children with autism, intranasal oxytocin reduced salivary oxytocin receptor gene (OXTR) DNA-methylation compared with placebo.

    In plain wordsIn children with autism, nasal oxytocin lowered a chemical mark on the oxytocin receptor gene compared with placebo.

    Peptide
    Oxytocin
    Outcome
    DecreaseSalivary OXTR DNA-methylation
    Study

    n = 79

    Comparator
    Placebo
    Analysis
    Exploratory
    Outcome group
    Receptor activity and mechanism · Nervous system and cognition
    Studied dose
    12 IU twice daily · intranasal · four weeksAs given in this study (human).

    Source sentences

    Summary
    Regarding salivary oxytocin receptor gene (OXTR) epigenetics (DNA-methylation), oxytocin-induced reductions in OXTR DNA-methylation were observed, suggesting a facilitation of oxytocin receptor expression in the oxytocin compared to the placebo group.
    1 context sentence
    Summary · context
    children with autism (n = 79, 16 females) receiving intranasal oxytocin for four weeks (12 IU, twice daily)
  4. 04HumanRandomized controlled trialMechanism

    In children with autism, higher oxytocin levels after treatment were associated with reduced OXTR DNA-methylation and improved feelings of secure attachment.

    In plain wordsIn children with autism, higher oxytocin after treatment was linked to a lower gene methylation mark and better feelings of secure attachment.

    Peptide
    Oxytocin
    Outcome
    Not applicableAssociation of post-treatment oxytocin with OXTR methylation and secure attachment
    Study

    n = 79

    Analysis
    Exploratory
    Outcome group
    Receptor activity and mechanism · Nervous system and cognition
    Studied dose
    12 IU twice daily · intranasal · four weeksAs given in this study (human).

    Source sentences

    Summary
    Notably, heightened oxytocin levels post-treatment were significantly associated with reduced OXTR DNA-methylation and improved feelings of secure attachment.
    1 context sentence
    Summary · context
    children with autism (n = 79, 16 females) receiving intranasal oxytocin for four weeks (12 IU, twice daily)

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)

CompletedPhase 2NCT06945926

The Effect of Oxytocin Nasal Spray on Preventing Postoperative Delirium in Elderly Patients Undergoing Orthopedic Surgery

Zhejiang Universityn = 2271 Jun 2025 to 2 Jun 2026

Cervical Spinal Stenosis · Thoracic Spinal Stenosis · Lumbar Spinal Stenosis · Rotator Cuff Injury · Femoral Head Necrosis · Spinal Trauma · Knee Joint Injury

Trial pageClinicalTrials.govUpdated 20 Aug 2026

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, 00:50 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 02:47 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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