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Brain Imaging Study of Adults With Autism Spectrum Disorders

Plain-language guide to NCT01093768: phase 1 randomized trial of Oxytocin and Vasopressin, 38 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT01093768
Phase
phase 1
Status
completed
Start
2010-02-19
Completion (planned or actual)
2013-04-11
Participants
38 (actual)
Design
randomized, diagnostic
Conditions studied
Autism Spectrum Disorders
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

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

This research study investigates the effects of oxytocin and vasopressin on brain activity in adults with Autism Spectrum Disorders using functional magnetic resonance imaging (fMRI).

Background: \- Oxytocin and vasopressin are two hormones produced in the brain.

Both hormones can influence activity in brain regions such as the amygdala that are involved in social and emotional processing.

The registry classes the interventions as drug.

More on the Plan

Design: This will be a double-blind cross-over functional magnetic resonance imaging (fMRI) study, requiring three visits in addition to a screening visit.

At each visit, participants will receive an intranasal application of oxytocin, vasopressin, or placebo and will be scanned while performing social cognition tasks and tasks involving the processing of affective stimuli.

Their main brain region of interest will be the amygdala.

Who Took Part

Enrollment: 38 actual participants took part.

It was open to people of any sex aged from 18 years up to 40 years.

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

The full record lists 1 inclusion and 0 exclusion criteria.

How the Study Was Run

The set-up was randomized and crossover.

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.

It started in 2010-02-19 with completion listed for 2013-04-11.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

Researchers chose this as the main measure: Changes in brain activations (time frame: 1.5 hours).

It also tracked 1 secondary outcome, for example Performance scores and reaction time on behavioral tasks.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin and Vasopressin in 38 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 and the Vasopressin compound page, all human trials.

Our Notes on the Compounds

Oxytocin: A peptide hormone with established obstetric medical uses and a less settled role in research on behavior, sexual function and appetite.

Vasopressin: A 9-amino-acid hormone (antidiuretic hormone) that controls water balance and blood vessel tone; used in septic shock.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.