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Trial · Interventional

CompletedPhase 2Registry data

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

NCTNCT01038570 (opens ClinicalTrials.gov in a new tab)Other id09 071 03
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
24 participants (actual)
Sponsor
University Hospital, Toulouse · Other
Design
Randomized · Triple masking
Countries
1 country

France

Start
Jun 2009
Primary completion
Sept 2009
Completion
Sept 2009
First posted
24 Dec 2009 (estimated)
Last update posted
12 May 2017
Conditions
Prader Willi Syndrome

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20092010
  1. Ph 2

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

    NCT01038570

    Jun 2009 to Sept 2009

Registry summary

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

The role of oxytocin (OT) is already known in the regulation of satiety but some clinical studies demonstrated that OT participates also in the regulation of social behavior by its implication on a better comprehension of emotion which plays a role on theory of mind and empathy. By the way, these 2 behaviors are deviants for patients with Prader-Willi Syndrome (PWS). Actually, no study was led on the effect of OT on PWS patients but Swaab and al in 1995 showed a significant reduction in number and in volume of neurons expressing OT in the paraventricular nucleus of PWS patients. Recent data were obtained studying OT in patients with autism which showed a link between the deregulation of OT and the autistic pathology. Clinical and imaging studies obtained with PWS and autistic populations make us believe that some mechanisms are common between these two pathologies. The objectives of this project are: 1. to look for an influence on the understanding of the social codes of the PWS patients, 2. to look for an influence on the behavior of stress and anxiety and on the regulation of eating habits when patients receive a nasal pulverizing of OT.

Interventions

  • Syntocinon®/- SprayDrug
  • Physiological serum (Sodium chloride)Drug

Arms2

  • Experimental

    Oxytocin

  • Placebo comparator

    Physiological serum

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Result scores at Psychological tests : "Reading the mind in the eyes" (RMET), Tests for evaluation of the "theory of mind" : Sally and Ann, Cartoons,"L'esprit des autres", "Social Attribution Task" (SAT).

    Time frame · fourth day

Secondary outcomes(1)

  1. Result scores at daily stress, anxiety and eating behavior tests

    Time frame · Five days (first day to fifth day)

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

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 PDFSee results (5)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * PWS genetically confirmed, * Age 18-year-old superior, * Negative pregnancy test. Exclusion Criteria: * Severe psychiatric troubles * Problem administration staff, * Saving of justice, * Abnormalities of the heart rhythm, * Hepatic or renal insufficiency, * Pregnancy, * Oxytocin hypersensibility, * Treatment causing rhythm disorders.

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