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Autism Oxytocin Brain Project

NCT03033784 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2021-01-12

Study results available
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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.

Conditions

Interventions

DRUG

8 International Units (IU) of Oxytocin

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

DRUG

24IU of Oxytocin

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

DRUG

48IU of Oxytocin

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

DRUG

Placebo

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

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Elissar Andari, PhD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-10
Primary Completion
2018-10-03
Completion
2018-10-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03033784 on ClinicalTrials.gov