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Completed

NCT Number: NCT02804373

Effects of Intranasal Administration of Oxytocin in Adults With Prader-Willi Syndrome

The investigator thinks that the oxytocin (OT) can improve durably and significantly the behavior disorders and thus the socialization but also the satisfaction and could thus be an interesting therapeutic alternative for the patients presenting a Prader-Willi Syndrome (SPW). Although today several studies demonstrated the effects of the OT in various domains of the behavior, the investigator do not know either its specificity of action about the cerebral level, or its duration of action, or the optimal modalities of administration and in particular at patients SPW.

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Key information

Conditions

Prader-Willi Syndrome Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Imprinting Disorders Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Centre de référence Prader-Willi - Hôpital Purpan

Toulouse, 31059, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Prader-Willi syndrome genetically confirmed
  • Absence of extension of the QT interval in the electrocardiogram
  • Absence of hypokalemia

Exclusion criteria

  • Psychiatric troubles
  • Anomalies of the heart rhythm in significant ECG
  • Hepatic insufficiency
  • Renal insufficiency
  • Patients presenting a pregnancy or breast-feeding
  • High sensibility to OT
  • High sensibility to the excipients of the product
  • Patients having family history of genetic pathology causing an extension of the interval QT
  • Patients having risk factors of advanced twist

Treatment and study plan

Oxytocin (OXT) continuous

Drug

Administration of 24 IU of oxytocin daily during 28 days

Other names: Syntocinon

Placebo

Drug

Placebo daily during 28 days

Placebo continuous

Drug

Placebo administration the following 2 days after each OXT administration, during 28 days.

Oxytocin

Drug

Administration of 24 IU of oxytocin every 3 days during 28 days.

Other names: Syntocinon

Primary outcomes

  1. Change in Behaviour as assessed by score variations in specific questionaries

    Time frame: Every day before and after administration of treatment during 28 days

  2. Change in eating Behaviour as assessed by score variations in specific questionaries

    Time frame: Every day before and after administration of treatment during 28 days

Secondary outcomes

  1. Change in eating behaviour as assessed by score variations in hunger visual analogic scale

    Time frame: Every day before and after administration of treatment during 28 days

  2. Cerebral Metabolism variations as assessed by Positron Emission Tomography (PET-scan)

    Time frame: Day 1, day 2 and day 30

    Brain imaging

  3. Cerebral Metabolism variations as assessed by functional Magnetic Resonance Imaging (f-RMI)

    Time frame: Day 1, day 2 and day 29

    Brain imaging

  4. Evaluation of social skills assessed by specific questionnaires

    Time frame: Day 1, day 2 and day 30

  5. Evaluation of executive function assessed by specific questionnaires

    Time frame: Day 1, day 2 and day 30

  6. Evaluation of theory of mind assessed by specific questionnaires

    Time frame: Day 1, day 2 and day 30

  7. Social processing assessed by oculomotor exploration

    Time frame: Day 1, day 2 and day 30

  8. Multisensory processing assessed by Neurovisual task

    Time frame: Day 1, day 2 and day 30

  9. Hormon blood concentration levels as assessed by bioassays

    Time frame: Day 2 and day 30

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: PRADOTIM

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jun 17, 2016
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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