Oxytocin in young children with Prader-Willi syndrome: Results of a randomized, double-blind, placebo-controlled, crossover trial investigating 3 months of oxytocin.

Damen L, Grootjen LN, Juriaans AF, Donze SH, Huisman TM, Visser JA, Delhanty PJD, Hokken-Koelega ACS

Clinical endocrinology21 Dec 2020Cited by 45 (Europe PMC)

PMID33296519PMCIDPMC8246775DOI10.1111/cen.14387PepBankPUB-33296519

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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: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study6

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

01HumanRandomized controlled trialEfficacy outcome
In children with Prader-Willi syndrome, intranasal oxytocin had no significant effect on social behaviour in the total group versus placebo.
In plain wordsIn children with Prader-Willi syndrome, nasal oxytocin did not significantly change social behaviour overall compared with placebo.
Peptide
Oxytocin
Outcome
No significant changeSocial behaviour (Oxytocin Questionnaire) in total group
Study
n = 26
Comparator
Placebo
Outcome group
Social behavior and cognition · Nervous system and cognition
Studied dose
16-40 IU/day · intranasal · 3 monthsAs given in this study (human).
Source sentences
Summary
In the total group, no significant effects of oxytocin on social behaviour
2 context sentences(design, population, supporting numbers)
Summary · context
To evaluate the effects of 3 months of twice daily intranasal oxytocin (dose range 16-40 IU/day), compared to placebo, on behaviour and hyperphagia in children with PWS.
Summary · context
Twenty-six children with PWS aged 3-11 years.
Report a problemFND-3329651901
02HumanRandomized controlled trialEfficacy outcome
In children with Prader-Willi syndrome, intranasal oxytocin had no significant effect on hyperphagia in the total group versus placebo.
In plain wordsIn children with Prader-Willi syndrome, nasal oxytocin did not significantly change excessive hunger overall compared with placebo.
Peptide
Oxytocin
Outcome
No significant changeHyperphagia (Dykens questionnaire) in total group
Study
n = 26
Comparator
Placebo
Outcome group
Appetite and food intake · Nervous system and cognition
Studied dose
16-40 IU/day · intranasal · 3 monthsAs given in this study (human).
Source sentences
Summary
In the total group, no significant effects of oxytocin on social behaviour or hyperphagia
2 context sentences(design, population, supporting numbers)
Summary · context
To evaluate the effects of 3 months of twice daily intranasal oxytocin (dose range 16-40 IU/day), compared to placebo, on behaviour and hyperphagia in children with PWS.
Summary · context
Twenty-six children with PWS aged 3-11 years.
Report a problemFND-3329651902
03HumanRandomized controlled trialSafety outcome
In children with Prader-Willi syndrome, intranasal oxytocin was well tolerated and there were no serious adverse events.
In plain wordsIn children with Prader-Willi syndrome, nasal oxytocin was well tolerated, with no serious side effects.
Peptide
Oxytocin
Outcome
No significant changeTolerability and serious adverse events
Study
n = 26
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
16-40 IU/day · intranasal · 3 monthsAs given in this study (human).
Source sentences
Summary
Oxytocin treatment was well tolerated, and there were no serious adverse events.
2 context sentences(design, population, supporting numbers)
Summary · context
To evaluate the effects of 3 months of twice daily intranasal oxytocin (dose range 16-40 IU/day), compared to placebo, on behaviour and hyperphagia in children with PWS.
Summary · context
Twenty-six children with PWS aged 3-11 years.
Report a problemFND-3329651906
04HumanRandomized controlled trialEfficacy outcome
In boys with Prader-Willi syndrome, Oxytocin Questionnaire scores improved significantly during oxytocin treatment, compared with a deterioration during placebo.
In plain wordsIn boys with Prader-Willi syndrome, social behaviour scores improved with nasal oxytocin, while they worsened with placebo.
Peptide
Oxytocin
Outcome
IncreaseOxytocin Questionnaire score in boys
Study
n: not reported in source
Comparator
Placebo
Outcome group
Social behavior and cognition · Nervous system and cognition
Studied dose
16-40 IU/day · intranasal · 3 monthsAs given in this study (human).
Measurements
Oxytocin Questionnaire change
4.5 points
oxytocin
Oxytocin Questionnaire change
−4 points
placebo
Source sentences
Summary
However, in boys, the Oxytocin Questionnaire scores improved significantly during oxytocin treatment, compared to a deterioration during placebo (4.5 (-0.8 to 15.3) vs. -4.0 (-11.3 to 0.8), P = .025).
2 context sentences(design, population, supporting numbers)
Summary · context
To evaluate the effects of 3 months of twice daily intranasal oxytocin (dose range 16-40 IU/day), compared to placebo, on behaviour and hyperphagia in children with PWS.
Summary · context
Twenty-six children with PWS aged 3-11 years.
Report a problemFND-3329651903
05HumanRandomized controlled trialEfficacy outcome
In children with Prader-Willi syndrome, Dykens hyperphagia scores remained similar during oxytocin treatment, while they deteriorated during placebo.
In plain wordsIn children with Prader-Willi syndrome, hunger scores stayed the same with nasal oxytocin, but got worse with placebo.
Peptide
Oxytocin
Outcome
No significant changeDykens hyperphagia questionnaire score
Study
n: not reported in source
Comparator
Placebo
Outcome group
Appetite and food intake · Nervous system and cognition
Studied dose
16-40 IU/day · intranasal · 3 monthsAs given in this study (human).
Measurements
Dykens hyperphagia change
0 points
oxytocin
Dykens hyperphagia change
−3.5 points
placebo
Source sentences
Summary
The Dykens hyperphagia questionnaire scores remained similar during oxytocin treatment, while there was a deterioration during placebo (0.0 (-0.8 to 4.3) vs. -3.5 (-6.0 to 0.0), P = .046).
2 context sentences(design, population, supporting numbers)
Summary · context
To evaluate the effects of 3 months of twice daily intranasal oxytocin (dose range 16-40 IU/day), compared to placebo, on behaviour and hyperphagia in children with PWS.
Summary · context
Twenty-six children with PWS aged 3-11 years.
Report a problemFND-3329651904
06HumanRandomized controlled trialEfficacy outcome
In children with Prader-Willi syndrome and a deletion, both questionnaire scores improved significantly during oxytocin treatment, with deteriorations during placebo.
In plain wordsIn children with Prader-Willi syndrome and a deletion, behaviour and hunger scores improved with nasal oxytocin but worsened with placebo.
Peptide
Oxytocin
Outcome
IncreaseQuestionnaire scores in patients with a deletion
Study
n: not reported in source
Comparator
Placebo
Outcome group
Social behavior and cognition · Nervous system and cognition
Studied dose
16-40 IU/day · intranasal · 3 monthsAs given in this study (human).
Source sentences
Summary
Patients with a deletion had significant improvements in both questionnaire scores during oxytocin treatment, but deteriorations during placebo.
2 context sentences(design, population, supporting numbers)
Summary · context
To evaluate the effects of 3 months of twice daily intranasal oxytocin (dose range 16-40 IU/day), compared to placebo, on behaviour and hyperphagia in children with PWS.
Summary · context
Twenty-six children with PWS aged 3-11 years.
Report a problemFND-3329651905

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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.

Version 2Current
11 Oct 2026, 00:50 UTC
Study results updated
Version 1
9 Oct 2026, 02:48 UTC
First added · source update from Europe PMC

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