Modulation of Reinforcement Learning

What Was Tested

The trial (not phased) is built around Oxytocin.

This study aims to examine the modulation of neuronal and behavioural parameters of social reinforcement learning.

It had two arms (groups): Cross over Oxytocin and Placebo (other) and Cross over Placebo and Oxytocin (other).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 60 actual participants took part.

It was open to men only aged from 18 years up to 26 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age between 18 and 26 years. Written informed consent. Proband understands character, extent and individual consequences of the study. Competent persons who are able to follow the instructions of the study personnel. For ASD patients: assured ASD diagnosis, comply of the ASD criteria ADI-R/ADOS-G.

The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: anaphylaxis of oxytocin or other chemical substances; metal inside the body or other contraindications of mri scan; physical illness which can affect the examinations or endanger the proband.

How the Study Was Run

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

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both Oxytocin and the comparison in turn, acting as their own control.

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

Those kept unaware of assignments: participant and investigator.

It started in 2013-10-18 with completion listed for 2016-08-07.

It ran at 1 site in Germany.

Its stated primary purpose is diagnostic.

What Was Measured

Researchers chose this as the main measure: Bold Signal in nucleus accumbens (time frame: 1 Day).

It also tracked 1 secondary outcome, for example Bold signal in ventral tegmental areal.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 60 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.