Phase 2
N=51
Autism Oxytocin Brain Project
Autism · Autism Spectrum Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03033784 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Resting State Functional Connectivity (rsFC) Salience Network (Anterior Cingulate Cortex (ACC) and Insula Versus Visual Cortex) — 0.338; 0.400; 0.428; 0.522 z-scores rsFC salience-visual
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 8 International Units (IU) of Oxytocin (Drug); 24IU of Oxytocin (Drug); 48IU of Oxytocin (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Emory University
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Resting State Functional Connectivity (rsFC) Salience Network (Anterior Cingulate Cortex (ACC) and Insula Versus Visual Cortex) |
0.338; 0.400; 0.428; 0.522; 0.591 | — |
| PRIMARY Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues |
0.347824; -0.758427; -0.602304; 0.33747; -0.540874; 0.313911 | — |
| PRIMARY Percent Change in Blood Oxygen Level Dependent (BOLD) Activity During Ball-Game Task |
0.2568; 0.1379; 0.1631; 0.3304; 0.3502; 0.3141 | — |
| PRIMARY Oxytocin Plasma Concentration |
8.09; 11.17; 9.06; 9.72; 7.75; 14.36 | — |
| SECONDARY Rate of Smiling During Global Clinical Interview |
0.954; 0.954; 1.013; 1.015 | — |
| SECONDARY Milliseconds of Visual Fixation |
91786.05; 82503.23; 134913.00; 130600.90 | — |
| SECONDARY Social Learning Test (SLT) Reaction Time |
939.43; 972.08; 905.99; 896.63; 762.72; 969.17 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03033784). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.