An fMRI Study of the Effect of Intravenous Oxytocin vs. Placebo on Response Inhibition and Face Processing in Autism

What Was Tested

The trial (phase 1) is built around Oxytocin.

To study the effect of oxytocin on face processing and response inhibition in autistic adults by fMRI.

It had two arms (groups): Pitocin (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Autism is a developmental disorder affecting approximately 60/10,000 individuals.

It is characterized by social and language deficits and repetitive behaviors/restricted interests.

Functional imaging is becoming a very useful tool in trying to understand the neurobiology of autism.

Oxytocin is a hormone produced by the brain to assist with labor and lactation.

Who Took Part

16 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: Meet DSM-IV, ADI, or ADOS criteria for autism spectrum disorder. Be seen as outpatients.

The full record lists 5 inclusion and 8 exclusion criteria; among the exclusions: subjects who are pregnant or nursing mothers. sexually active women of childbearing potential who are not using adequate birth control measures; subjects with epilepsy; subjects with a history of schizophrenia, schizoaffective disorder or other axis 1 mental disorders, such as bipolar disorder.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

Those kept unaware of assignments: participant and investigator.

It started in 2006-03 with completion listed for 2010-10.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in BOLD with oxytocin infusion (time frame: baseline and 4 hours).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 16 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.