Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency

What Was Tested

In this phase 1 trial, researchers set out to test Oxytocin.

Following a screening visit to determine eligibility, participants will return for three main study visits in Part A.

During the main study visits, study participants will receive either oxytocin or placebo, followed by assessments of emotional behavior.

It had eight arms (groups): Part A Arm 1 (experimental), Part A Arm 2 (experimental), Part A Arm 3 (experimental), Part A Arm 4 (experimental) and Part A Arm 5 (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 40 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Age 18 and above. Normal serum/plasma sodium. Stable hormone replacement.

The full record lists 5 inclusion and 11 exclusion criteria; among the exclusions: active substance use disorder within the last 6 months; history of psychosis; medication changes that could interfere with study procedures or endpoints per study physician discretion.

How the Study Was Run

The set-up was randomized, crossover and quadruple-blind.

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

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

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 2025-09-10 with completion listed for 2027-06.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

It also tracked 3 secondary outcomes, for example Dot-probe task - anxious behavior between all three interventions, Depressive behavior - probabilistic reward task between all three interventions and Socioemotional functioning - Emotion recognition task between all three interventions.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 40 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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