Autism Oxytocin Brain Project

NCT03033784 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: IRB00093455P50MH100023
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism; Autism Spectrum Disorder

Keywords

Neuroscience

Outcome Measures

Primary Outcomes (4)

• Resting State Functional Connectivity (rsFC) Salience Network (Anterior Cingulate Cortex (ACC) and Insula Versus Visual Cortex)

  Investigators will study the effects of intranasal oxytocin (IN-OT) on the resting state functional connectivity between key socio-emotional and social salience brain regions using functional magnetic resonance imaging (fMRI). Resting state functional connectivity is a task-independent metric of brain activity that is based on correlations between low-frequency fluctuations of the blood oxygen level-dependent signal between several brain regions. It reflects the strength of a functional connection that is in good agreement with the underlying neuroanatomy and provides a system-level understanding of brain function. Z-scores represent the number of standard deviations from the mean of 0 and range from -3 to +3, and z-scores greater than 0 indicate greater than average resting state functional connectivity.

  Post Intervention (Up to 40 minutes after receiving spray) at Study Visits 1, 2, 3 and 4

• Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues

  BOLD activity level was assessed via fMRI during completion of the face perception task (FPT) of emotional and neutral faces. BOLD scores are reported on a z-scale, with the mean, standard deviation and the minimum and the maximum. This refers to the non-thresholded z-scores that are obtained for each dose before conducting small volume correction analysis.

  Post Intervention (Up to 70 minutes) at Study Visits 1, 2, 3, and 4

• Percent Change in Blood Oxygen Level Dependent (BOLD) Activity During Ball-Game Task

  BOLD activity in social-emotional brain regions during the perception of emotional facial videos were measured during the ball-game task. Mean percent change in contrast of parameter estimates in anatomical regions of interest are presented here. A positive value indicates increased BOLD activity while a negative value indicates decreased BOLD activity.

  Post Intervention (up to 70 minutes) at Study Visits 1, 2, 3, and 4

• Oxytocin Plasma Concentration

  Plasma concentration of oxytocin prior to administration of study intervention and after administration of study intervention will be compared between the different dose levels and placebo. Plasma concentration of oxytocin is expected to increase following administration of intranasal oxytocin.

  Visits 1, 2, 3 and 4 (before spray and 5 minutes after spray)

Secondary Outcomes (3)

• Rate of Smiling During Global Clinical Interview

  Post Intervention (Up to 180 minutes after receiving spray) at Study Visits 1, 2, 3 and 4

• Milliseconds of Visual Fixation

  Post Intervention (Up to 50 minutes) at Study Visits 1, 2, 3 and 4

• Social Learning Test (SLT) Reaction Time

  Post Intervention (Up to 130 minutes) at Study Visits 1, 2, 3 and 4

Study Arms (2)

Autism Spectrum Disorder (ASD)

EXPERIMENTAL

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.

Drug: 8 International Units (IU) of Oxytocin; Drug: 24IU of Oxytocin; Drug: 48IU of Oxytocin; Drug: Placebo

Healthy Control

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

8 International Units (IU) of Oxytocin DRUG

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

Also known as: syntocinon

Autism Spectrum Disorder (ASD)

24IU of Oxytocin DRUG

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

Also known as: syntocinon

Autism Spectrum Disorder (ASD)

48IU of Oxytocin DRUG

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

Also known as: syntocinon

Autism Spectrum Disorder (ASD)

Placebo DRUG

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

Autism Spectrum Disorder (ASD); Healthy Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• IQ \> 70
• Normal or corrected-to-normal vision
• History of seizures
• Neurological disorder

Sponsors & Collaborators

• Emory University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Elissar Andari, PhD
• Organization: The University of Toledo

elissar.andari@Utoledo.edu

419-383-5227

Study Officials

• Elissar Andari, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Assistant Professor

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: January 27, 2017
• Study Start: May 10, 2017
• Primary Completion: October 3, 2018
• Study Completion: October 3, 2018
• Last Updated: January 12, 2021
• Results First Posted: January 12, 2021

Record last verified: 2020-12

Locations

US (1)