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Study · Randomized controlled trial · n = 24 · 2011

5 results

Oxytocin may be useful to increase trust in others and decrease disruptive behaviours in patients with Prader-Willi syndrome: a randomised placebo-controlled trial in 24 patients.

Tauber M, Mantoulan C, Copet P, Jauregui J, Demeer G, Diene G, Rogé B, Laurier V, Ehlinger V, Arnaud C, Molinas C, Thuilleaux D

Orphanet journal of rare diseases24 Jun 2011Cited by 81 (Europe PMC)

PMID21702900 (opens in a new tab)PMCIDPMC3141367 (opens in a new tab)DOI10.1186/1750-1172-6-47 (opens in a new tab)PepBankPUB-21702900
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Summary

BackgroundPrader-Willi syndrome (PWS) is a complex neurodevelopmental genetic disorder with hypothalamic dysfunction, early morbid obesity with hyperphagia, and specific psychiatric phenotypes including cognitive and behavioural problems, particularly disruptive behaviours and frequent temper outbursts that preclude socialization. A deficit in oxytocin (OT)-producing neurons of the hypothalamic paraventricular nucleus has been reported in these patients.MethodsIn a double-blind, randomised, placebo-controlled study, 24 adult patients with PWS received a single intranasal administration of 24 IU of OT or placebo and were tested 45 min later on social skills. Behaviours were carefully monitored and scored using an in-house grid as follows: over the two days before drug administration, on the half-day following administration, and over the subsequent two days. All patients were in a dedicated PWS centre with more than ten years of experience. Patients are regularly admitted to this controlled environment.ResultsPatients with PWS who received a single intranasal administration of OT displayed significantly increased trust in others (P = 0.02) and decreased sadness tendencies (P = 0.02) with less disruptive behaviour (P = 0.03) in the two days following administration than did patients who received placebo. In the half-day following administration, we observed a trend towards less conflict with others (p = 0.07) in the OT group compared with the placebo group. Scores in tests assessing social skills were not significantly different between the two groups.ConclusionsThis study needs to be reproduced and adapted. It nevertheless opens new perspectives for patients with PWS and perhaps other syndromes with behavioural disturbances and obesity.Trial registration numberClinicalTrials.gov: NCT01038570.
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 adults with Prader-Willi syndrome, a single intranasal dose of oxytocin increased trust in others in the two days after dosing versus placebo.

    In plain wordsIn adults with Prader-Willi syndrome, one nasal dose of oxytocin increased trust in others more than placebo over two days.

    Peptide
    Oxytocin
    Outcome
    IncreaseTrust in others
    Study

    n = 24

    Comparator
    Placebo
    Outcome group
    Social behavior and cognition · Mental health and mood
    Studied dose
    24 IU · intranasal · single doseAs given in this study (human).

    Source sentences

    Summary
    Patients with PWS who received a single intranasal administration of OT displayed significantly increased trust in others (P = 0.02) and decreased sadness tendencies (P = 0.02) with less disruptive behaviour (P = 0.03) in the two days following administration than did patients who received placebo.
    1 context sentence
    Summary · context
    In a double-blind, randomised, placebo-controlled study, 24 adult patients with PWS received a single intranasal administration of 24 IU of OT or placebo and were tested 45 min later on social skills.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In adults with Prader-Willi syndrome, a single intranasal dose of oxytocin decreased sadness tendencies in the two days after dosing versus placebo.

    In plain wordsIn adults with Prader-Willi syndrome, one nasal dose of oxytocin reduced sadness tendencies more than placebo over two days.

    Peptide
    Oxytocin
    Outcome
    DecreaseSadness tendencies
    Study

    n = 24

    Comparator
    Placebo
    Outcome group
    Anxiety and mood · Mental health and mood
    Studied dose
    24 IU · intranasal · single doseAs given in this study (human).

    Source sentences

    Summary
    Patients with PWS who received a single intranasal administration of OT displayed significantly increased trust in others (P = 0.02) and decreased sadness tendencies (P = 0.02) with less disruptive behaviour (P = 0.03) in the two days following administration than did patients who received placebo.
    1 context sentence
    Summary · context
    In a double-blind, randomised, placebo-controlled study, 24 adult patients with PWS received a single intranasal administration of 24 IU of OT or placebo and were tested 45 min later on social skills.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In adults with Prader-Willi syndrome, a single intranasal dose of oxytocin reduced disruptive behaviour in the two days after dosing versus placebo.

    In plain wordsIn adults with Prader-Willi syndrome, one nasal dose of oxytocin reduced disruptive behaviour more than placebo over two days.

    Peptide
    Oxytocin
    Outcome
    DecreaseDisruptive behaviour
    Study

    n = 24

    Comparator
    Placebo
    Outcome group
    Anxiety and mood · Mental health and mood
    Studied dose
    24 IU · intranasal · single doseAs given in this study (human).

    Source sentences

    Summary
    Patients with PWS who received a single intranasal administration of OT displayed significantly increased trust in others (P = 0.02) and decreased sadness tendencies (P = 0.02) with less disruptive behaviour (P = 0.03) in the two days following administration than did patients who received placebo.
    1 context sentence
    Summary · context
    In a double-blind, randomised, placebo-controlled study, 24 adult patients with PWS received a single intranasal administration of 24 IU of OT or placebo and were tested 45 min later on social skills.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In adults with Prader-Willi syndrome, oxytocin showed only a non-significant trend towards less conflict with others in the half-day after dosing versus placebo.

    In plain wordsIn adults with Prader-Willi syndrome, oxytocin showed only a trend, not a clear difference, towards less conflict than placebo in the first half-day.

    Peptide
    Oxytocin
    Outcome
    No significant changeConflict with others in the half-day after dosing
    Study

    n = 24

    Comparator
    Placebo
    Outcome group
    Social behavior and cognition · Mental health and mood
    Studied dose
    24 IU · intranasal · single doseAs given in this study (human).

    Source sentences

    Summary
    In the half-day following administration, we observed a trend towards less conflict with others (p = 0.07) in the OT group compared with the placebo group.
    1 context sentence
    Summary · context
    In a double-blind, randomised, placebo-controlled study, 24 adult patients with PWS received a single intranasal administration of 24 IU of OT or placebo and were tested 45 min later on social skills.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In adults with Prader-Willi syndrome, social skills test scores did not differ significantly between oxytocin and placebo.

    In plain wordsIn adults with Prader-Willi syndrome, social skills test scores were not clearly different between oxytocin and placebo.

    Peptide
    Oxytocin
    Outcome
    No significant changeSocial skills test scores
    Study

    n = 24

    Comparator
    Placebo
    Outcome group
    Social behavior and cognition · Mental health and mood
    Studied dose
    24 IU · intranasal · single doseAs given in this study (human).

    Source sentences

    Summary
    Scores in tests assessing social skills were not significantly different between the two groups.
    1 context sentence
    Summary · context
    In a double-blind, randomised, placebo-controlled study, 24 adult patients with PWS received a single intranasal administration of 24 IU of OT or placebo and were tested 45 min later on social skills.

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

Registered trials3

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

3 trials · 3 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
CompletedPhase 1NCT02013258

Oxytocin Trial in Prader-Willi Syndrome

University of Floridan = 24Mar 2015 to Aug 2015

Prader Willi Syndrome

Trial pageClinicalTrials.govUpdated 5 Apr 2018
CompletedPhase 2NCT01038570

Comparative Study Between Prader-Willi Patients Who Take Oxytocin Versus Placebo

University Hospital, Toulousen = 24Jun 2009 to Sept 2009

Prader Willi Syndrome

Trial pageClinicalTrials.govUpdated 12 May 2017

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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