CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 51 enrolled
Drug / intervention
8 International Units (IU) of Oxytocin +3 moredrug
Likely dose
24IU of Oxytocinfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03033784
NCT03033784Phase 2Completed
CompareCT.gov

Target Engagement for Intranasal Oxytocin in Autism Spectrum Disorders, an fMRI Dose Response Study

Emory University·interventional·Posted Jan 27, 2017·Updated Jan 12, 2021

In Brief

A Phase 2 clinical trial evaluating 8 International Units (IU) of Oxytocin, 24IU of Oxytocin, and 2 other interventions for Autism and Autism Spectrum Disorder. Completed, enrolled 51 participants across 1 site.

Detailed Summary

The main goal of the study is to look at the effects of intranasal oxytocin on the brain in Autism Spectrum Disorder (ASD). Oxytocin is a hormone that exists naturally in the body and the brain, affecting a wide range of social behaviors and emotions. The investigators will study the effects of different treatments (3 doses of oxytocin and one dose of placebo) on brain functional connectivity at rest in patients with ASD, using functional magnetic resonance imaging (fMRI). Investigators also seek to study how the effects of oxytocin treatment can be affected by genetic, immune and environmental factors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutism, Autism Spectrum Disorder
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 27, 2017
Enrollment StartMay 10, 2017
Primary CompletionOct 3, 2018
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.4 years ago

Interventions

8 International Units (IU) of Oxytocindrug

Participants will receive one dose of intranasal oxytocin at a dose of 8IU.

24IU of Oxytocindrug

Participants will receive one dose of intranasal oxytocin at a dose of 24IU.

48IU of Oxytocindrug

Participants will receive one dose of intranasal oxytocin at a dose of 48IU.

Placebodrug

Participants will receive an intranasal placebo to match the oxytocin doses.