Trial · Interventional

CompletedNot applicableRegistry data

Oxytocin Intranasal Administrations in Children With Prader-Willi Syndrome Aged From 3 to 12 Years

Short name Oxyjeune

NCTNCT03114371Other id15 7837 03Other id2016-003273-18Other id2016

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Not applicable
Enrollment: 40 participants (actual)
Sponsor: University Hospital, Toulouse · Other
Design: Randomized · Double masking
Countries: 1 country
France
Start: 28 Nov 2016
Primary completion: Jan 2019
Completion: 11 Jan 2019
First posted: 14 Apr 2017
Last update posted: 12 Nov 2020
Conditions: Prader-Willi Syndrome

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20162017201820192020

N/A
Oxyjeune
NCT03114371
28 Nov 2016 to 11 Jan 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Positive results in preclinical and clinical studies in adults and infants with Prader-Willi syndrome lead investigators to set up a new study in children with Prader-Willi syndrome. The objective of this study is to document effects of oxytocin intranasal administrations on behavioural troubles in children with Prader-Willi syndrome aged from 3 to 12 years.

Interventions

OxytocinDrug
PlaceboDrug
OxytocinDrug

Arms2

Experimental
Oxytocin
Daily intranasal administrations of oxytocin for 12 weeks, followed by an open-label period of 12 weeks of oxytocin. Oxytocin dose will be 8 International Unit for patients aged from 3 to 6 years and 16 International Unit for patients aged from 7 to 12 years.
Placebo comparator
Placebo
Daily intranasal administrations of placebo for 12 weeks, followed by an open-label period of 12 weeks of oxytocin. Oxytocin dose will be International Unit for patients aged from 3 to 6 years and 16 International Unit for patients aged from 7 to 12 years.

Primary outcomes1

Outcomes the sponsor listed as primary.

Evolution of behavioural troubles evaluated by the global score of Child Behavior Check List Questionnaire after 12 weeks of oxytocin/placebo treatment.
Time frame · Week 12
Registry description
It's variation between inclusion and 12 weeks of total score total problems from the Child Behavior Check List Questionnaire.

Secondary outcomes(8)

Evaluation of hyperphagia after 12 weeks of oxytocin/placebo treatment.
Time frame · Week 12
Registry description
It is the variation of each of the three sub-scores obtained from the Dykens hyperphagia questionnaire between day 0 and week 12.
Evaluation of social skills after 12 weeks of oxytocin/placebo treatment.
Time frame · Week 12
Registry description
It is variation between day 0 and week 12 of the total score obtained from the social skills assessment questionnaire for children aged from 3 to 6 years and the Social Responsiveness Scale questionnaire for children aged from 7 to 12 years.
Evaluation of auto- and hetero-aggressive after 12 weeks of oxytocin/placebo treatment.
Time frame · Week 12
Registry description
It is variation between day 0 and week 12 of the total score obtained from the self-aggression assessment questionnaire.
Evaluation of psychopathology after 12 weeks of oxytocin/placebo treatment.
Time frame · Week 12
Registry description
It is the variation of the following sub-scores obtained from the Child Behaviour Check List questionnaire (only the following 3 subscales) between day 0 and week 12.
Evaluation of global clinical status after 12 weeks of oxytocin/placebo treatment.
Time frame · Weeks 12
Registry description
It is improvement of the patient's overall clinical condition after 12 weeks of treatment with oxytocin/placebo. It's assessed by the Clinical Global Impression Scale's score. This scale of improvement of Clinical Global Impression is a 7-point ordinal qualitative scale of "very greatly improved" rated + 3 to "very strongly aggravated" rated -3. The result is expressed in total score which varies from -3 to +3.
Evaluation of acyl and desacyl ghrelin plasma levels after 12 weeks of oxytocin/placebo treatment.
Time frame · Week 12
Registry description
It is evolution of circulating levels of acylated and deacylated ghrelin will be the variations of these rates and the variation of the relationships between day 0 and week 12.
Evaluation of attentional abilities after 12 weeks of oxytocin/placebo treatment, for patients aged from 7 to 12 years at inclusion.
Time frame · Week 12
Registry description
It is evolution of attentional abilities is evaluated by a computerized test, the Attention Network Test.
Evaluation of metabolic brain resting state after 12 weeks of oxytocin/placebo treatment, for patients aged from 7 to 12 years at inclusion.
Time frame · Week 12
Registry description
It is evolution of metabolic brain resting state is evaluated by a magnetic resonance imaging to study the cerebral metabolism between day 0 and week 12.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies11

Studies that cite this trial.

Studies with results

10 studies on this page

Indexing hint: Randomized controlled trial · 2016

5 results

The effect of oxytocin nasal spray on social interaction deficits observed in young children with autism: a randomized clinical crossover trial.

Yatawara et al. 2016Molecular psychiatrycited by 265

PMID 26503762PMC4995545DOI 10.1038/mp.2015.162PUB-26503762

Free to read · publisher termsCC BY-NC-ND5 results

Read at source See results (5)

Indexing hint: Randomized controlled trial · 2015

3 results

The effects of a course of intranasal oxytocin on social behaviors in youth diagnosed with autism spectrum disorders: a randomized controlled trial.

Guastella et al. 2015Journal of child psychology and psychiatry, and allied disciplinescited by 227

PMID 25087908DOI 10.1111/jcpp.12305PUB-25087908

Full text at the publisher3 results

Publisher page See results (3)

Indexing hint: Randomized controlled trial · 2014

2 results

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

Einfeld et al. 2014American journal of medical genetics. Part Acited by 103

PMID 24980612DOI 10.1002/ajmg.a.36653PUB-24980612

Full text at the publisher2 results

Publisher page See results (2)

Indexing hint: Randomized controlled trial · 2012

5 results

Effects of intranasal oxytocin on social anxiety in males with fragile X syndrome.

Hall et al. 2012Psychoneuroendocrinologycited by 107

PMID 21862226PMC3353652DOI 10.1016/j.psyneuen.2011.07.020PUB-21862226

Rights unknown5 results

Source link See results (5)

Indexing hint: Randomized controlled trial · 2012

3 results

Oxytocin increases amygdala reactivity to threatening scenes in females.

Lischke et al. 2012Psychoneuroendocrinologycited by 156

PMID 22365820DOI 10.1016/j.psyneuen.2012.01.011PUB-22365820

Full text at the publisher3 results

Publisher page See results (3)

Indexing hint: Systematic review · 2011

3 results

A review of safety, side-effects and subjective reactions to intranasal oxytocin in human research.

MacDonald et al. 2011Psychoneuroendocrinologycited by 276

PMID 21429671DOI 10.1016/j.psyneuen.2011.02.015PUB-21429671

Full text at the publisher3 results

Publisher page See results (3)

Indexing hint: Randomized controlled trial · 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 et al. 2011Orphanet journal of rare diseasescited by 81

PMID 21702900PMC3141367DOI 10.1186/1750-1172-6-47PUB-21702900

CC BY5 results

Download PDF See results (5)

Indexing hint: Randomized controlled trial · 2010

2 results

Intranasal oxytocin improves emotion recognition for youth with autism spectrum disorders.

Guastella et al. 2010Biological psychiatrycited by 686

PMID 19897177DOI 10.1016/j.biopsych.2009.09.020PUB-19897177

Full text at the publisher2 results

Publisher page See results (2)

Indexing hint: Clinical trial · 2005

3 results

Oxytocin increases trust in humans.

Kosfeld et al. 2005Naturecited by 1,701

PMID 15931222DOI 10.1038/nature03701PUB-15931222

Full text at the publisher3 results

Publisher page See results (3)

Indexing hint: Case report · 1995

3 results

Alterations in the hypothalamic paraventricular nucleus and its oxytocin neurons (putative satiety cells) in Prader-Willi syndrome: a study of five cases.

Swaab et al. 1995The Journal of clinical endocrinology and metabolismcited by 299

PMID 7852523DOI 10.1210/jcem.80.2.7852523PUB-07852523

Rights unknown3 results

Source link See results (3)

More studies

1 study on this page

Indexing hint: Animal study · 2010

A single postnatal injection of oxytocin rescues the lethal feeding behaviour in mouse newborns deficient for the imprinted Magel2 gene.

Schaller et al. 2010Human molecular geneticscited by 190

PMID 20876615DOI 10.1093/hmg/ddq424PUB-20876615

Full text at the publisher

Publisher page

Eligibility

Who could join, as posted.

Sex: All
Age: from 3 Years up to 12 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * patient with a complete genetic diagnosis of Prader-Willi syndrome * patient treated by growth hormone for at least 1 year * patient naïve for oxytocin for at least 5 years Exclusion Criteria: * patient who do not accept intranasal administrations (major behavioural trouble) * patient with hepatic insufficiency : serum transaminases (SGOT, SGPT) higher than 3 times normal values for age * patient with renal insufficiency : serum creatinine higher than 3 times normal values for age * patient with an antecedent of abnormal electrocardiogram * patient with arterial hypertension or hypotension * patient with type 1 or 2 diabetes

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