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Study · Randomized controlled trial · n = 30 · 2025

5 results

Random forest and Shapley Additive exPlanations predict oxytocin targeted effects on brain functional networks involved in salience and sensorimotor processing, in a randomized clinical trial in autism.

Andari E, Gopinath K, O'Leary E, Caceres GA, Nishitani S, Smith AK, Ousley O, Rilling JK, Cubells JF, Young LJ

Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology2 Apr 2025Cited by 1 (Europe PMC)

PMID40175527 (opens in a new tab)PMCIDPMC12260019 (opens in a new tab)DOI10.1038/s41386-025-02095-2 (opens in a new tab)PepBankPUB-40175527
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Summary

Intranasal oxytocin (IN-OXT) has shown some promises in rescuing social deficits in autism spectrum disorder (ASD) as well as some inconsistencies in long-term trials. We conducted a target engagement study to study the precise effects of different doses of IN-OXT on brain resting-state functional connectivity (rsFC) in ASD. We examined the effects of varying doses of IN-OXT (0 IU, 8 IU, 24 IU, 48 IU) on rsFC in a double-blind, placebo-controlled, within-subject design in 30 male adults with ASD and 17 neurotypical controls (NT) receiving placebo. Random forest analysis was used to classify individuals as ASD or NT. Shapely Additive explanations values were calculated to rank brain functional networks by level of contribution to ASD deficits and to evaluate IN-OXT dose effects. The model predicted ASD diagnosis with an AUC of 94%. Hypoconnectivity between salience/empathy and visual networks, and hyperconnectivity between reward and sensorimotor networks and theory of mind networks were among the strongest predictors of ASD deficits. IN-OXT had a dose-dependent effect on rescuing both deficits described above. Overall, 48 IU dose was more effective, and 24 IU dose was more effective in those who have lower DNA OXT receptor methylation and lower severity of clinical symptoms. Higher doses of OXT might be necessary to enhance empathic responses, and ASD individuals with less support needs and with a preserved OXT system might benefit most from OXT treatment. Applying machine learning approaches in OXT research can provide data-driven unbiased results that can inform future clinical trials.
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.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In male adults with autism, intranasal oxytocin had a dose-dependent effect that rescued hypoconnectivity between salience/empathy and visual networks.

    In plain wordsIn men with autism, nasal oxytocin shifted weak brain connectivity toward the typical pattern, with a bigger effect at higher doses.

    Peptide
    Oxytocin
    Outcome
    IncreaseHypoconnectivity between salience/empathy and visual networks
    Study

    n = 30

    Comparator
    Placebo
    Outcome group
    Brain and neuronal activity · Nervous system and cognition
    Studied dose
    8 IU, 24 IU and 48 IU · intranasalAs given in this study (human).

    Source sentences

    Summary
    IN-OXT had a dose-dependent effect on rescuing both deficits described above.
    1 context sentence
    Summary · context
    We examined the effects of varying doses of IN-OXT (0 IU, 8 IU, 24 IU, 48 IU) on rsFC in a double-blind, placebo-controlled, within-subject design in 30 male adults with ASD and 17 neurotypical controls (NT) receiving placebo.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In male adults with autism, intranasal oxytocin had a dose-dependent effect that rescued hyperconnectivity between reward and sensorimotor networks and theory of mind networks.

    In plain wordsIn men with autism, nasal oxytocin shifted overly strong brain connectivity toward the typical pattern, with a bigger effect at higher doses.

    Peptide
    Oxytocin
    Outcome
    DecreaseHyperconnectivity between reward and sensorimotor networks and theory of mind networks
    Study

    n = 30

    Comparator
    Placebo
    Outcome group
    Brain and neuronal activity · Nervous system and cognition
    Studied dose
    8 IU, 24 IU and 48 IU · intranasalAs given in this study (human).

    Source sentences

    Summary
    IN-OXT had a dose-dependent effect on rescuing both deficits described above.
    1 context sentence
    Summary · context
    We examined the effects of varying doses of IN-OXT (0 IU, 8 IU, 24 IU, 48 IU) on rsFC in a double-blind, placebo-controlled, within-subject design in 30 male adults with ASD and 17 neurotypical controls (NT) receiving placebo.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In male adults with autism, the 48 IU dose of intranasal oxytocin was more effective overall than the other doses on connectivity deficits.

    In plain wordsIn men with autism, the highest nasal oxytocin dose worked best overall on brain connectivity.

    Peptide
    Oxytocin
    Outcome
    Not applicableOverall effect of 48 IU on connectivity deficits
    Study

    n = 30

    Comparator
    Placebo
    Outcome group
    Brain and neuronal activity · Nervous system and cognition
    Studied dose
    48 IU · intranasalAs given in this study (human).

    Source sentences

    Summary
    Overall, 48 IU dose was more effective, and 24 IU dose was more effective in those who have lower DNA OXT receptor methylation and lower severity of clinical symptoms.
    1 context sentence
    Summary · context
    We examined the effects of varying doses of IN-OXT (0 IU, 8 IU, 24 IU, 48 IU) on rsFC in a double-blind, placebo-controlled, within-subject design in 30 male adults with ASD and 17 neurotypical controls (NT) receiving placebo.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In male adults with autism, the 24 IU dose was more effective in those with lower DNA oxytocin receptor methylation.

    In plain wordsIn men with autism, the middle nasal oxytocin dose worked better in those with lower oxytocin receptor methylation.

    Peptide
    Oxytocin
    Outcome
    Not applicableEffect of 24 IU by DNA OXT receptor methylation
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Brain and neuronal activity · Nervous system and cognition
    Studied dose
    24 IU · intranasalAs given in this study (human).

    Source sentences

    Summary
    Overall, 48 IU dose was more effective, and 24 IU dose was more effective in those who have lower DNA OXT receptor methylation and lower severity of clinical symptoms.
    1 context sentence
    Summary · context
    We examined the effects of varying doses of IN-OXT (0 IU, 8 IU, 24 IU, 48 IU) on rsFC in a double-blind, placebo-controlled, within-subject design in 30 male adults with ASD and 17 neurotypical controls (NT) receiving placebo.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In male adults with autism, the 24 IU dose was more effective in those with lower severity of clinical symptoms.

    In plain wordsIn men with autism, the middle nasal oxytocin dose worked better in those with milder symptoms.

    Peptide
    Oxytocin
    Outcome
    Not applicableEffect of 24 IU by clinical symptom severity
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Brain and neuronal activity · Nervous system and cognition
    Studied dose
    24 IU · intranasalAs given in this study (human).

    Source sentences

    Summary
    Overall, 48 IU dose was more effective, and 24 IU dose was more effective in those who have lower DNA OXT receptor methylation and lower severity of clinical symptoms.
    1 context sentence
    Summary · context
    We examined the effects of varying doses of IN-OXT (0 IU, 8 IU, 24 IU, 48 IU) on rsFC in a double-blind, placebo-controlled, within-subject design in 30 male adults with ASD and 17 neurotypical controls (NT) receiving placebo.

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

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, 02:48 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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