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

NCT01038570 | Completed Phase 2 DMC

• 1 other identifier: 09 071 03
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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. 1.to look for an influence on the understanding of the social codes of the PWS patients,
2. 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.

Conditions

Prader Willi Syndrome

Keywords

Prader Willi syndrome; adults; social behaviour; stress; anxiety; psychological tests

Outcome Measures

Primary Outcomes (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).

  fourth day

Secondary Outcomes (1)

• Result scores at daily stress, anxiety and eating behavior tests

  Five days (first day to fifth day)

Study Arms (2)

Oxytocin

EXPERIMENTAL

Drug: Syntocinon®/- Spray

Physiological serum

PLACEBO COMPARATOR

Drug: Physiological serum (Sodium chloride)

Interventions

Syntocinon®/- Spray DRUG

3 sprays corresponding to 24 IU in each nostril

Oxytocin

Physiological serum (Sodium chloride) DRUG

Sodium chloride 0.9 % (0.3 ml) in each nostril

Physiological serum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PWS genetically confirmed,
• Age 18-year-old superior,
• Negative pregnancy test.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Hôpital marin d'Hendaye

Hendaye, Pyrénées-Atlantiques, 64704, France

Location

Related Publications (1)

• Tauber M, Mantoulan C, Copet P, Jauregui J, Demeer G, Diene G, Roge B, Laurier V, Ehlinger V, Arnaud C, Molinas C, Thuilleaux D. 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. Orphanet J Rare Dis. 2011 Jun 24;6:47. doi: 10.1186/1750-1172-6-47.

  PMID: 21702900 RESULT

MeSH Terms

Conditions

Prader-Willi Syndrome; Social Behavior; Anxiety Disorders

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Imprinting Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Maïthé TAUBER, MD

  Centre de référence du syndrome de Prader-Willi - Equipe d'Endocrinologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2009
• First Posted: December 24, 2009
• Study Start: June 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: May 12, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)