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

What Was Tested

This registered phase 2, phase 3 trial tested Oxytocin.

It had three arms (groups): placebo daily (placebo comparator), one (active comparator) and one (active comparator).

Daily administration of placebo during 28 days : placebo continuous.

The registry classes the interventions as drug.

Who Took Part

50 actual participants took part.

It was open to people of any sex aged from 18 years up to 50 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Prader-Willi syndrome genetically confirmed. Absence of extension of the QT interval in the electrocardiogram. Absence of hypokalemia.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: psychiatric troubles; hepatic insufficiency; renal insufficiency.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

The Oxytocin group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2014-06 with completion listed for 2019-01.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Behaviour as assessed by score variations in specific questionaries (time frame: Every day before and after administration of treatment during 28 days). 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).

It also tracked 9 secondary outcomes, for example Change in eating behaviour as assessed by score variations in hunger visual analogic scale, Cerebral Metabolism variations as assessed by Positron Emission Tomography (PET-scan), Cerebral Metabolism variations as assessed by functional Magnetic Resonance Imaging (f-RMI), Evaluation of social skills assessed by specific questionnaires, Evaluation of executive function assessed by specific questionnaires and Evaluation of theory of mind assessed by specific questionnaires.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Oxytocin in 50 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.