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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01038570
Recruitment Status : Completed
First Posted : December 24, 2009
Last Update Posted : May 12, 2017
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:

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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : June 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  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 Outcome Measures :
  1. Result scores at daily stress, anxiety and eating behavior tests [ Time Frame: Five days (first day to fifth day) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01038570

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

Publications of Results:
Responsible Party: University Hospital, Toulouse Identifier: NCT01038570     History of Changes
Other Study ID Numbers: 09 071 03
First Posted: December 24, 2009    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Prader-Willi Syndrome
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Nutrition Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Reproductive Control Agents
Physiological Effects of Drugs