Oxytocin and Cognitive Control in Adult ADHD

What Was Tested

The trial (early phase 1) is built around Oxytocin.

Following a screening visit to determine eligibility, participants will return for two main study visits.

It had two arms (groups): Drug order: Oxytocin - placebo (experimental) and Drug order: Placebo - oxytocin (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 24 actual participants took part.

It was open to men only aged from 18 years up to 55 years.

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

Examples of who could join: Diagnosis of attention deficit/hyperactivity disorder.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: history of cardiovascular disease (e.g., hypertrophic cardiomyopathy, valvular heart disease, coronary heart disease, or coronary artery spasms); history of diabetes mellitus; untreated thyroid disease.

How the Study Was Run

It was run as a randomized, crossover and triple-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.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2017-12-14 with completion listed for 2020-11-05.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Stop-signal task (time frame: First and second main study visits (1-4 weeks apart)).

It also tracked 4 secondary outcomes, for example AX-CPT, Category switch task, Global/local task and Simon task.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Oxytocin in 24 people.

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

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.