Autism Oxytocin Brain Project

NCT ID: NCT03033784

Last Updated: 2021-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-10
• Study Completion Date: 2018-10-03

Brief 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.

Detailed Description

This study consists of investigating the effects of several doses of acute administration of intranasal oxytocin on brain activity in adults with Autism Spectrum Disorder (ASD). There is increasing evidence for the role of intranasal oxytocin (IN-OT) in enhancing social skills in ASD. Nevertheless, there is still a need of determining target engagement for oxytocin's action on brain and behavior. Here, investigators are studying the effects of different doses of IN-OT on the modulation of behavioral outcomes and neural responses in a double blind crossover study in individuals with ASD.

The aims of the research are to:

1. Study the effects of IN-OT doses on the modulation of brain functional connectivity between key socio-emotional brain regions during resting state in ASD

2. Study the effects of IN-OT doses on the blood-oxygen-level dependent (BOLD) activity of key emotional and perceptual brain networks in response to social cues (such as faces)

3. Study the effects of IN-OT on the BOLD activity of brain regions during an interactive social environment (ball game) in ASD

Investigators will compare the neuroimaging and behavioral results of individuals with ASD to control healthy males who will receive intranasal placebo. Investigators are also investigating the role of genetic factors, behavioral or clinical sub-groups of ASD, immune and environmental factors in modulating the effect of IN-OT on brain and behavior.

Participants with ASD will undergo 4 clinical visits during which they receive various randomly assigned doses of intranasal oxytocin and placebo. Both participants and the experimenter will be blind to the type of the treatment administered.

There will be only one visit for healthy controls who will all receive placebo spray. The visit for healthy controls will be conducted in a single-blind design. The experimenter will be aware that the subject is receiving placebo. However, the participant will be told that he might receive oxytocin or placebo.

Conditions

Autism; Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Autism Spectrum Disorder (ASD)

Male participants diagnosed with ASD will receive 12 puffs (6 in each nostril) of intranasal oxytocin (syntocinon) and placebo (assigned randomly) during 4 study visits.

Group Type: EXPERIMENTAL

8 International Units (IU) of Oxytocin

Intervention Type: DRUG

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

24IU of Oxytocin

Intervention Type: DRUG

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

48IU of Oxytocin

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

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

Healthy Control

Age matched healthy controls will receive placebo intranasal spray (12 puffs, 6 per nostril) during one study visit.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

8 International Units (IU) of Oxytocin

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

Intervention Type: DRUG

24IU of Oxytocin

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

Intervention Type: DRUG

48IU of Oxytocin

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

syntocinon; syntocinon; syntocinon

Eligibility Criteria

Inclusion Criteria

• Have an ASD diagnosis based on the Autism Diagnostic Observation Schedule (ADOS) and Autism Diagnostic Interview (ADI) criteria, gold standards of research-based autism diagnosis
• Intelligence quotient (IQ) > 70
• Normal or corrected-to-normal vision

• IQ > 70
• Normal or corrected-to-normal vision

Exclusion Criteria

• Recent occurrence of seizures (past 5 years)
• Brain damage or head trauma (can be included at discretion of PI and sponsor)
• Color blind
• Cardiovascular disease
• Presence of a severe medical problem
• Severe mental retardation
• Alcoholism or substance abuse
• Asthma (can be included at the discretion of study physician/nurse practitioner if episodes are infrequent and no active problems at time of the study)
• Migraine headaches (at the discretion of the nurse practitioner or the study physician)
• Claustrophobia (at discretion of study physician/designee/PI)
• Pacemakers, cochlear implants, surgical clips or metal fragments

• History of seizures
• Neurological disorder
• Current psychiatric disorder
• Previous psychiatric disorder (can be included at discretion of PI)
• Current use of psychoactive drugs
• Previous use of psychoactive drugs (can be included at discretion of PI)
• Head trauma (can be included at discretion of PI)
• Alcoholism or substance abuse
• Cardiovascular disease
• Color blind
• Asthma (can be included at the discretion of study physician/nurse practitioner if episodes are infrequent and no active problems at time of the study)
• Migraine headaches (at the discretion of the nurse practitioner or the study physician)
• Claustrophobia (at discretion of study physician/designee/PI)
• Presence of a severe medical problem
• Severe mental retardation
• Pacemakers, cochlear implants, surgical clips or metal fragments

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Elissar Andari

Adjunct Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elissar Andari, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00093455

Identifier Type: -

Identifier Source: org_study_id

P50MH100023

Identifier Type: NIH

Identifier Source: secondary_id

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