AutismPhase 2NCT03033784

Autism Oxytocin Brain Project

A Phase 2 study testing 8 International Units (IU) of Oxytocin, 24IU of Oxytocin and 48IU of Oxytocin in people with Autism and Autism Spectrum Disorder, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Autism, Autism Spectrum Disorder
What is being tested?: 8 International Units (IU) of Oxytocin, 24IU of Oxytocin and 48IU of Oxytocin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 51 participants
Where: 1 siteUnited States
Study dates: 10 May 2017to 3 Oct 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Show all 27Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Emory University
Atlanta, Georgia, 30322

Other trials in United States

About this study

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

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.

Read the 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:

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
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)
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
Being tested: 8 International Units (IU) of Oxytocin, 24IU of Oxytocin, 48IU of Oxytocin, Placebo
Keywords: Neuroscience
Medical subject headings: Autistic Disorder, Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

8 International Units (IU) of OxytocinDrug
Also called syntocinon
Participants will receive one dose of intranasal oxytocin at a dose of 8IU.
24IU of OxytocinDrug
Also called syntocinon
Participants will receive one dose of intranasal oxytocin at a dose of 24IU.
48IU of OxytocinDrug
Also called syntocinon
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.

Study groups in NCT03033784
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

Rate of Smiling During Global Clinical Interview
Clinical improvements will be rated by a clinician as based on a videotaped interview conducted after the MRI scanning session. Values between the different treatment conditions will be assessed to study the effect of intranasal oxytocin on ASD at the clinical level. The improvement will be assessed based on the quality of social interaction between the experimenter and the participant, specifically as the amount of smiling behavior displayed by participants. Larger values indicate that participants are smiling more frequently.
Measured: Post Intervention (Up to 180 minutes after receiving spray) at Study Visits 1, 2, 3 and 4
Milliseconds of Visual Fixation
Eye gaze will be recorded via an eye tracker inside the MRI scanner during the face perception task (FPT). Visual fixation between different treatment conditions will be assessed in ASD participants.
Measured: Post Intervention (Up to 50 minutes) at Study Visits 1, 2, 3 and 4
Social Learning Test (SLT) Reaction Time
During the SLT, participants complete an implicit association test using faces and words. The faces that are presented in this task are partners' faces with whom participants played during the ball-game inside the MRI scanner. In this task, there are congruent blocks where neutral faces of "positive" partners are presented with friendly words and neutral faces of "negative" partners are presented with unfriendly words. During incongruent blocks, neutral faces of "positive" partners are presented with unfriendly words and neutral faces of "negative" partners are presented with friendly words. Participants match the face or the word to one of two categories. Longer reaction time indicates difficulty with selecting a category. Longer reaction time in incongruent trials signifies implicit biases were formed for the positive and negative players such that "positive" partners from the ball-game are now perceived as friendly and "negative" partners are now perceived as unfriendly.
Measured: Post Intervention (Up to 130 minutes) at Study Visits 1, 2, 3 and 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 May 20173 Oct 2018

First posted27 Jan 2017 (estimated)
Study start10 May 2017
Primary completion3 Oct 2018
Study completion3 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AutismStudies of the same condition, open and under way.
More trials run by Emory UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03033784
Sponsor's protocol ID: IRB00093455
Other IDs: P50MH100023
Status last verified: Dec 2020
First submitted: 24 Jan 2017
Last updated: 12 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Autism trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Target Engagement for Intranasal Oxytocin in Autism Spectrum Disorders, an fMRI Dose Response Study
ClinicalTrials.gov ID: NCT03033784
Acronym / sponsor ID: IRB00093455
Conditions: Autism, Autism Spectrum Disorder
Keywords: Neuroscience
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 10 May 2017 (actual)
Primary completion: 3 Oct 2018 (actual)
Study completion: 3 Oct 2018 (actual)
First posted: 27 Jan 2017 (estimated)
Results: Posted 12 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The aims of the research are to:

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Autism Spectrum Disorder (ASD)	Experimental	Drug: 8 International Units (IU) of Oxytocin, Drug: 24IU of Oxytocin, Drug: 48IU of Oxytocin, Drug: PlaceboMale participants diagnosed with ASD will receive 12 puffs (6 in each nostril) of intranasal oxytocin (syntocinon) and placebo (assigned randomly) during 4 study visits.
Healthy Control	Placebo comparator	Drug: PlaceboAge matched healthy controls will receive placebo intranasal spray (12 puffs, 6 per nostril) during one study visit.

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (27 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
8 International Units (IU) of OxytocinAlso: syntocinonParticipants will receive one dose of intranasal oxytocin at a dose of 8IU.	Drug	Autism Spectrum Disorder (ASD)
24IU of OxytocinAlso: syntocinonParticipants will receive one dose of intranasal oxytocin at a dose of 24IU.	Drug	Autism Spectrum Disorder (ASD)
48IU of OxytocinAlso: syntocinonParticipants will receive one dose of intranasal oxytocin at a dose of 48IU.	Drug	Autism Spectrum Disorder (ASD)
PlaceboParticipants will receive an intranasal placebo to match the oxytocin doses.	Drug	Autism Spectrum Disorder (ASD), Healthy Control

Primary outcome

Resting State Functional Connectivity (rsFC) Salience Network (Anterior Cingulate Cortex (ACC) and Insula Versus Visual Cortex)
Time frame: Post Intervention (Up to 40 minutes after receiving spray) at Study Visits 1, 2, 3 and 4
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.
Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
Time frame: Post Intervention (Up to 70 minutes) at Study Visits 1, 2, 3, and 4
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.
Percent Change in Blood Oxygen Level Dependent (BOLD) Activity During Ball-Game Task
Time frame: Post Intervention (up to 70 minutes) at Study Visits 1, 2, 3, and 4
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.
Oxytocin Plasma Concentration
Time frame: Visits 1, 2, 3 and 4 (before spray and 5 minutes after spray)
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.

3 secondary outcomes

Rate of Smiling During Global Clinical Interview
Time frame: Post Intervention (Up to 180 minutes after receiving spray) at Study Visits 1, 2, 3 and 4
Milliseconds of Visual Fixation
Time frame: Post Intervention (Up to 50 minutes) at Study Visits 1, 2, 3 and 4
Social Learning Test (SLT) Reaction Time
Time frame: Post Intervention (Up to 130 minutes) at Study Visits 1, 2, 3 and 4

Results and safety

Results posted to the registry on 12 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dose Order: Placebo, 8 International Units (IU), 24IU, 48IU	9	9
Dose Order: 24IU, 8IU, Placebo, 48IU	2	1
Dose Order: 24IU, Placebo, 8IU, 48IU	4	4
Dose Order: 48IU, Placebo, 8IU, 24IU	4	4
Dose Order: 8IU, 24IU, Placebo, 48IU	3	3
Dose Order: 48IU, 24IU, 8IU, Placebo	2	2
Dose Order: Placebo, 48IU, 24IU, 8IU	2	2
Dose Order: Placebo, 24IU, 48IU, 8IU	2	2
Dose Order: 48IU, 24IU, Placebo, 8IU	1	1
Dose Order: 8IU, 24IU, 48IU, Placebo	1	1
Dose Order: 24IU, 48IU, 8IU, Placebo	1	1
Dose Order: 48IU, 8IU, Placebo, 24IU	1	1
Healthy Controls Receiving the Placebo	19	17

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

Time frame: Post Intervention (Up to 40 minutes after receiving spray) at Study Visits 1, 2, 3 and 4. Mean (Standard Deviation). Unit: z-scores rsFC salience-visual

Measure	Placebo in ASD Participants n = 30	8IU of Oxytocin Spray n = 30	24IU of Oxytocin Spray n = 30	48IU of Oxytocin Spray n = 30	Healthy Controls Receiving Placebo n = 17
Value	0.338 (0.331)	0.400 (0.261)	0.428 (0.248)	0.522 (0.216)	0.591 (0.214)

Population analysed: This analysis includes participants with complete data for all visits. Two participants withdrew and data from another participant were not able to be analyzed due to technical problems during the MRI.

Primary outcome: Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues

Time frame: Post Intervention (Up to 70 minutes) at Study Visits 1, 2, 3, and 4. Mean (Full Range). Unit: z-scores

Measure	Placebo in ASD Participants n = 26	8IU of Oxytocin Spray n = 28	24IU of Oxytocin Spray n = 29	48IU of Oxytocin Spray n = 25	Healthy Controls Receiving Placebo n = 17
Face versus Fixation, Insular Cortex	0.347824 (-3.086408 to 2.294047)	-0.758427 (-2.614224 to 0.614738)	-0.602304 (-2.746292 to 1.613434)	0.33747 (-2.70115 to 2.94780)	-0.540874 (-3.423316 to 2.087243)
Face versus Fixation, Cingulate Gyrus, Anterior Division	0.313911 (-2.50618 to 2.058421)	-0.59443 (-2.122833 to 1.013119)	-0.922999 (-2.996872 to 2.020612)	0.03105 (-2.13638 to 2.62367)	-0.573381 (-3.103699 to 2.334144)
Face versus Fixation, Frontal Orbital Cortex	0.517829 (-2.3038 to 3.234023)	-0.339727 (-2.099626 to 2.850896)	0.133334 (-2.105783 to 2.2979)	0.51544 (-2.51943 to 3.32401)	0.504016 (-2.080812 to 3.234903)
Face versus Fixation, Occipital Fusiform Gyrus	3.427291 (-0.812082 to 5.631112)	3.556448 (-1.039342 to 6.120963)	3.403614 (-1.445628 to 5.572412)	3.39230 (-1.00470 to 5.80665)	3.322934 (-0.978423 to 6.224413)
Face versus Fixation, Left Laterobasal Amygdala	-0.003581 (-1.595989 to 2.935086)	-0.46194 (-1.821512 to 0.953573)	0.347864 (-1.570765 to 1.521856)	1.06647 (-1.74681 to 2.66841)	1.341538 (-1.84355 to 3.69492)
Face versus Fixation, Right Laterobasal Amygdala	0.817701 (-0.488433 to 1.900966)	-0.80763 (-1.895006 to 2.793559)	0.57701 (-0.796838 to 2.303261)	0.989042 (-2.810703 to 3.013389)	1.03517 (-2.307756 to 3.598735)
Face versus Fixation, Left Accumbens	0.324295 (-1.939803 to 1.759384)	-0.358148 (-1.451141 to 0.765259)	-0.76235 (-1.917312 to 0.928076)	-0.364131 (-1.405679 to 1.852745)	-0.859178 (-2.026179 to 1.316851)

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

Time frame: Post Intervention (up to 70 minutes) at Study Visits 1, 2, 3, and 4. Mean (Standard Error). Unit: percent change in contrast

Measure	Placebo in ASD Participants n = 22	8IU of Oxytocin Spray n = 22	24IU of Oxytocin Spray n = 22	48IU of Oxytocin Spray n = 22	Healthy Controls Receiving Placebo n = 16
Human Minus Computer, Negative Feedback, Left Amygdala	0.2568 (0.0563)	0.1379 (0.0494)	0.1631 (0.0430)	0.3304 (0.0658)	0.3502 (0.0738)
Human Minus Computer, Negative Feedback, Right Amygdala	0.3141 (0.0621)	0.1118 (0.0452)	0.1979 (0.0490)	0.3576 (0.0641)	0.3823 (0.0796)
Human Minus Computer, Negative Feedback, Right Laterobasal Amygdala	0.1724 (0.0476)	0.0921 (0.0379)	0.0984 (0.0362)	0.2569 (0.0666)	0.2258 (0.0479)
Human Minus Computer, Negative Feedback, Left Laterobasal Amygdala	0.1512 (0.0493)	0.0739 (0.0472)	0.1094 (0.0417)	0.2014 (0.0715)	0.2717 (0.0555)
Human Minus Computer, Negative Feedback, Ventral Anterior Insula (Sphere)	0.1830 (0.0801)	0.0311 (0.0574)	-0.0575 (0.0661)	0.1866 (0.0872)	0.0815 (0.0651)
Human Minus Computer, Negative Feedback, Anterior Cingulate (Sphere)	0.2604 (0.1109)	0.0953 (0.0630)	0.0419 (0.0497)	0.3214 (0.0780)	0.1406 (0.0525)
Human Minus Computer, Positive Feedback, Anterior Cingulate (Sphere)	0.2774 (0.0854)	0.0996 (0.0564)	0.1526 (0.0711)	0.2343 (0.0696)	0.1218 (0.0594)
Human Minus Computer, Positive Feedback, Frontal Orbital Cortex	0.2263 (0.0760)	0.1338 (0.0360)	0.1826 (0.0509)	0.1859 (0.0575)	0.2301 (0.0388)

Population analysed: This analysis includes participants with high quality images that were able to be examined. Some participants moved during the MRI resulting in distorted images.

Primary outcome: Oxytocin Plasma Concentration

Time frame: Visits 1, 2, 3 and 4 (before spray and 5 minutes after spray). Mean (Standard Deviation). Unit: picogram/milliliter

Measure	Placebo in ASD Participants n = 30	8IU of Oxytocin Spray n = 30	24IU of Oxytocin Spray n = 30	48IU of Oxytocin Spray n = 30
Prior to spray	8.09 (3.97)	11.17 (6.99)	9.06 (3.45)	9.72 (9.40)
After spray	7.75 (3.67)	14.36 (9.28)	17.52 (8.41)	20.86 (12.66)

Population analysed: Only participants with ASD had blood drawn for plasma oxytocin concentrations. This analysis includes participants who provided a blood sample (one refused to give a sample).

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 48 (0%)	3 of 48 (6.3%)	0 of 48
8IU of Oxytocin Spray	0 of 32 (0%)	4 of 32 (12.5%)	0 of 32
24IU of Oxytocin Spray	0 of 32 (0%)	5 of 32 (15.6%)	0 of 32
48IU of Oxytocin Spray	0 of 31 (0%)	5 of 31 (16.1%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elissar Andari, PhD principal investigator

Emory University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Resting State Functional Connectivity (rsFC) Salience Network (Anterior Cingulate Cortex (ACC) and Insula Versus Visual Cortex) (time frame: Post Intervention (Up to 40 minutes after receiving spray) at Study Visits 1, 2, 3 and 4). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03033784.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2021.