Double-blind Placebo Controlled Study of Oxytocin in Fragile X Syndrome

What Was Tested

In this phase 2 trial, researchers set out to test Oxytocin.

It had six arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

Twelve male adolescent (13-24 years) subjects with confirmed genetic diagnosis of FraX (full mutation) will participate in this randomized double-blind placebo-controlled study.

Subjects will then come into the lab for a final assessment on Day 30.

Who Took Part

10 actual participants took part.

It was open to men only aged from 13 years up to 29 years.

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

Examples of who could join: Confirmed genetic diagnosis of Fragile X (FraX) (full mutation). Male (who have more serious effects due to the X chromosome nature of the disorder). Age 13-29 years. Parent of adolescent must be willing to sign informed consent. Intelligence Quotient (IQ) \> 42.

The full record lists 5 inclusion and 2 exclusion criteria; among the exclusions: cardiac risk factors; medication exclusions: opiates or opiate antagonists, corticosteroids, typical or atypical antipsychotics.

How the Study Was Run

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

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

Each person switched between Oxytocin and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

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

It started in 2007-02 with completion listed for 2009-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Eye Contact/Gaze During 10 Minute Social Challenge Task (time frame: baseline, week 2, and week 3).

It also tracked 1 secondary outcome, for example Salivary Cortisol.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 10 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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