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Study · Randomized controlled trial · n = 30 · 2014

2 results

A double-blind randomized controlled trial of oxytocin nasal spray in Prader Willi syndrome.

Einfeld SL, Smith E, McGregor IS, Steinbeck K, Taffe J, Rice LJ, Horstead SK, Rogers N, Hodge MA, Guastella AJ

American journal of medical genetics. Part A30 Jun 2014Cited by 103 (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: Publisher copyright. Results still quote short attributed sentences.

Results from this study2

2 results from studies that gave the peptide. 2 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In people with Prader-Willi syndrome, intranasal oxytocin had little impact on any symptom measure versus placebo.

    In plain wordsIn people with Prader-Willi syndrome, oxytocin nasal spray had little effect on symptom measures compared with placebo.

    Peptide
    Oxytocin
    Outcome
    No significant changePWS symptom measures (behaviour, compulsion, hyperphagia, sleepiness, emotion recognition)
    Study

    n = 30

    Comparator
    Placebo
    Outcome group
    Anxiety and mood · Mental health and mood
    Studied dose
    24 IU or 18 IU twice daily, then 40 IU or 32 IU twice daily (by age) · intranasal · 8 weeksAs given in this study (human).

    Source sentences

    Summary
    Oxytocin had little impact on any measure.
    3 context sentences
    Summary · context
    Measures used to assess changes were standardized well-accepted measures, including the Developmental Behavior Checklist-Monitor, Parent, Teacher, and Adult; The Yale-Brown Obsessive Compulsive Scale; The Dykens Hyperphagia questionnaire; Reading The Mind in the Eyes Test; Epworth Sleepiness Scale and the Movie Stills.
    Summary · context
    Thirty individuals with PWS aged 12-30 years participated in an 18-week randomized double-blind placebo-controlled crossover trial.
    Summary · context
    Participants received 8 weeks of oxytocin and 8 weeks of placebo with a minimum 2-week washout period.
  2. 02HumanRandomized controlled trialSafety outcome

    In people with Prader-Willi syndrome, higher-dose intranasal oxytocin increased temper outbursts, the only significant difference found.

    In plain wordsIn people with Prader-Willi syndrome, higher-dose oxytocin nasal spray was linked to more temper outbursts, the only significant difference.

    Peptide
    Oxytocin
    Outcome
    IncreaseTemper outbursts at higher oxytocin dose
    Study

    n = 18

    Comparator
    Placebo
    Outcome group
    Anxiety and mood · Mental health and mood
    Studied dose
    40 IU twice daily (16 years and over); 32 IU twice daily (13-15 years) · intranasal · 8 weeksAs given in this study (human).

    Source sentences

    Summary
    The only significant difference found between the baseline, oxytocin, and placebo measures was an increase in temper outbursts (P = 0.023) with higher dose oxytocin.
    3 context sentences
    Summary · context
    The dose was increased for the remaining 18 participants to 40 IU B.I.D for participants 16 years and over and 32 IU B.I.D for 13-15 years.
    Summary · context
    Thirty individuals with PWS aged 12-30 years participated in an 18-week randomized double-blind placebo-controlled crossover trial.
    Summary · context
    Participants received 8 weeks of oxytocin and 8 weeks of placebo with a minimum 2-week washout period.

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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