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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01038570
First received: November 16, 2009
Last updated: January 6, 2010
Last verified: January 2010
  Purpose

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.

Condition Intervention Phase
Prader Willi Syndrome
Drug: Syntocinon®/- Spray
Drug: Physiological serum (Sodium chloride)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of the Oxytocin Administered in Nasal Pulverizing on the Social Skills, the Stress, the Anxiety and the Eating Habits at Grown-up Patients Presenting a Syndrome of Prader-Willi: Pilot Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Result scores at daily stress, anxiety and eating behavior tests [ Time Frame: Five days (first day to fifth day) ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: June 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oxytocin Drug: Syntocinon®/- Spray
3 sprays corresponding to 24 IU in each nostril
Placebo Comparator: Physiological serum Drug: Physiological serum (Sodium chloride)
Sodium chloride 0.9 % (0.3 ml) in each nostril

Detailed Description:

Recent clinical studies showed that the oxytocin (OT), next to its long-time known actions (lactation, satiety), participates in the regulation of the social behavior. 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 suggest a link between OT and the autistic pathology: the existence of a lower plasmatic rate on OT and the association with a polymorphism of the OT's receptor for autistics patients. Because OT has a role on the pro-social behavior and on the nervous control of the stress, the hypothesis on which a deficit in OT would play a role in the abnormalities of the social behavior was advanced. Moreover, certain features of the autistic spectrum disorder can be found in PWS patients. Moreover, a recent study has shown that OT administered by intra-nasal spray reduces psychosocial stress and increases the confidence in each other in healthy volunteers. The PWS is a genetic pathology and some clinical features are very similar to the autistic pathology. The PWS is the most common cause of syndromic autism. Data from the literature and a collaborative study conducted between our team and the Prof. B. Rogé's team suggests that these two pathologies share common pathophysiological mechanisms. To our knowledge, no study with the OT was conducted in people with PWS. We want to conduct a pilot study in adult patients with PWS. Given the severity of this disease, related to socialization disorders, significant anxiety and overeating, and with no effective therapy, this justifies the pilot study. Moreover, side effects of OT are almost nonexistent when used by intra-nasal.

Objectives: The objectives of this project are to investigate whether the administration by intra-nasal spray of OT plays a role on the understanding of social codes of PWS adult patients. We also analyze its effect on the level of stress, anxiety and eating behavior.

Methodology: This study is a double blind control study. We will include 24 PWS patients, aged over 18 years recruited at the Hendaye Marine Hospital (associated with the PWS reference center whose coordination is in Toulouse). The hospital routinely receives PWS adults for a 4 weeks stay which gives optimal conditions for the establishment of this study. Patients are separated into 2 groups matched one by one on the sex and IQ. One group receives the OT, the other a placebo. Forty five minutes after inhalation, all of the patients are evaluated on their social comprehension thanks to psychometric tests. Furthermore, an analysis based on observation sheets allows us to score daily stress, anxiety and eating behavior. These sheets serve for the comparison between 2 days before and 2 days after the nasal spray on the above described scoring components.

Results: Differences between the two groups will be statistically analyzed by non parametric statistical tests such as Mann-Whitney's test.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01038570

Locations
France
Hôpital marin d'Hendaye
Hendaye, Pyrénées-Atlantiques, France, 64704
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Maïthé TAUBER, MD Centre de référence du syndrome de Prader-Willi - Equipe d'Endocrinologie
  More Information

No publications provided by University Hospital, Toulouse

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nadège ALGANS, Direction de la Recherche - Hôtel-Dieu - Hospital of Toulouse
ClinicalTrials.gov Identifier: NCT01038570     History of Changes
Other Study ID Numbers: 09 071 03
Study First Received: November 16, 2009
Last Updated: January 6, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
Prader Willi syndrome
adults
social behaviour
stress
anxiety
psychological tests

Additional relevant MeSH terms:
Prader-Willi Syndrome
Syndrome
Abnormalities, Multiple
Chromosome Disorders
Congenital Abnormalities
Disease
Genetic Diseases, Inborn
Intellectual Disability
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Nutrition Disorders
Obesity
Overnutrition
Pathologic Processes
Oxytocin
Oxytocics
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014