Trial · Interventional

CompletedPhase 2Results postedRegistry data

Autism Oxytocin Brain Project

NCTNCT03033784Other idIRB00093455Other idP50MH100023

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 51 participants (actual)
Sponsor: Emory University · Other
Design: Randomized · Double masking
Countries: 1 country
United States
Start: 10 May 2017
Primary completion: 3 Oct 2018
Completion: 3 Oct 2018
First posted: 27 Jan 2017 (estimated)
Last update posted: 12 Jan 2021
Conditions: Autism · Autism Spectrum Disorder

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201720182019

Ph 2
Autism Oxytocin Brain Project
NCT03033784
10 May 2017 to 3 Oct 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

8 International Units (IU) of OxytocinDrug
24IU of OxytocinDrug
48IU of OxytocinDrug
PlaceboDrug

Arms2

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

Primary outcomes4

Outcomes the sponsor listed as primary.

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
Registry description
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
Registry description
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
Registry description
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)
Registry description
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.

Secondary outcomes(3)

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
Registry description
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.
Milliseconds of Visual Fixation
Time frame · Post Intervention (Up to 50 minutes) at Study Visits 1, 2, 3 and 4
Registry description
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.
Social Learning Test (SLT) Reaction Time
Time frame · Post Intervention (Up to 130 minutes) at Study Visits 1, 2, 3 and 4
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

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

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

Group	Value (z-scores rsFC salience-visual)	Spread
Placebo in ASD Participants	0.338	0.331
8IU of Oxytocin Spray	0.400	0.261
24IU of Oxytocin Spray	0.428	0.248
48IU of Oxytocin Spray	0.522	0.216
Healthy Controls Receiving Placebo	0.591	0.214

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

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

Group	Value (z-scores)
Placebo in ASD Participants	0.347824
8IU of Oxytocin Spray	-0.758427
24IU of Oxytocin Spray	-0.602304
48IU of Oxytocin Spray	0.33747
Healthy Controls Receiving Placebo	-0.540874

Primary outcomeMean· 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

Group	Value (percent change in contrast)	Spread
Placebo in ASD Participants	0.2568	0.0563
8IU of Oxytocin Spray	0.1379	0.0494
24IU of Oxytocin Spray	0.1631	0.0430
48IU of Oxytocin Spray	0.3304	0.0658
Healthy Controls Receiving Placebo	0.3502	0.0738

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

Oxytocin Plasma Concentration

Group	Value (picogram/milliliter)	Spread
Placebo in ASD Participants	8.09	3.97
8IU of Oxytocin Spray	11.17	6.99
24IU of Oxytocin Spray	9.06	3.45
48IU of Oxytocin Spray	9.72	9.40

Secondary and other outcome results(3)

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

Rate of Smiling During Global Clinical Interview

Group	Value (Smiles per minute)	Spread
Placebo in ASD Participants	0.954	0.724
8IU of Oxytocin Spray	0.954	0.801
24IU of Oxytocin Spray	1.013	0.810
48IU of Oxytocin Spray	1.015	0.744

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

Milliseconds of Visual Fixation

Group	Value (milliseconds)	Spread
Placebo in ASD Participants	91786.05	65288.71
8IU of Oxytocin Spray	82503.23	48615.57
24IU of Oxytocin Spray	134913.00	55067.12
48IU of Oxytocin Spray	130600.90	66305.70

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

Social Learning Test (SLT) Reaction Time

Group	Value (milliseconds)	Spread
Placebo in ASD Participants	939.43	605.79
8IU of Oxytocin Spray	972.08	950.41
24IU of Oxytocin Spray	905.99	741.22
48IU of Oxytocin Spray	896.63	679.50
Healthy Controls Receiving Placebo	762.72	335.81

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
PlaceboParticipants receiving the placebo	0 / 48	0 / 48	3 / 48
8IU of Oxytocin SprayParticipants receiving 8IU of oxytocin	0 / 32	0 / 32	4 / 32
24IU of Oxytocin SprayParticipants receiving 24IU of oxytocin	0 / 32	0 / 32	5 / 32
48IU of Oxytocin SprayParticipants receiving 48IU of oxytocin	0 / 31	0 / 31	5 / 31

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Male
Age: from 18 Years up to 45 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria for ASD Participants: * 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 Exclusion Criteria for ASD Participants: * 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 Inclusion Criteria for Healthy Age-Matched Controls: * IQ \> 70 * Normal or corrected-to-normal vision Exclusion Criteria for Healthy Age-Matched Controls: * 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

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