Autism Spectrum Disorders
Conditions
Keywords
Autism Spectrum Disorders, Oxytocin, Clinical Trial, Computer-based Intervention, Social Perception, Social Motivation, Social Cognition
Brief summary
The main objective of this study is to determine the safety and therapeutic potential of intranasal oxytocin in children and adolescents with autism spectrum disorder (ASD) when paired with a computer game intervention that is designed to enhance face perception skills.
Detailed description
Recognizing faces is critical to social functioning, and can be improved for individuals with ASD by using intervention software in the form of appropriately designed computer games. The effects of this type of social intervention may be amplified with the concurrent use of oxytocin. Furthermore, these learning effects may impact social skills in general and translate to the level of the individual's everyday social behavior. Thus, the objective of this study is to determine the safety and therapeutic potential of intranasal oxytocin in children and adolescents with ASD when paired with a computer game intervention that is designed to enhance face perception skills.
Interventions
DRUGIntranasal Oxytocin (Trade name: Syntocinon)
This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period.
Sponsors
Robert Schultz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Participants aged 12-17 years, Mental age ≥ 10 2. Gender: males 3. Diagnosis of an Autism Spectrum Disorder 4. Consent: parent/guardian permission and child assent. 5. Ability to complete tasks: adequate vision, motor control of a keyboard and mouse, and fluency in English (and English as a first language). 6. Study participant needs to be clinically stable, in the opinion of the study clinicians. Stability will be assessed by the clinicians based on information from and conversations with the parent, if necessary. The parent needs to commit verbally to not making any changes to his or her child's current treatments for the duration of this study.
Exclusion criteria
1. History of traumatic brain injury, epilepsy/seizure disorder (except febrile seizures), or other significant medical, genetic, or neurological abnormality affecting growth, development, or motor or higher cortical functioning. Sensory impairments (e.g., significant vision/hearing loss). 2. Patients with one or more of the following: Human immunodeficiency virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), hemophilia (bleeding problems, recent nose and brain injuries), abnormal blood pressure (hypotension or hypertension), drug abuse, immunity disorder, or severe depression. 3. Sensory impairments (e.g., significant vision/hearing loss). 4. Gestational age below 35 weeks and/or perinatal injury. 5. Profound mental retardation (e.g., Intelligence quotient (IQ) \< 45) or sensory-motor difficulties that would preclude valid use of diagnostic instruments. 6. Lack of impairment in face recognition as determined by average or above average performance on the Benton Face Recognition Task. 7. Female participants. 8. Patients who are sensitive to Syntocinon or any components of its formulation. 9. Fever at the time of the baseline visit, defined as temperature above 37.5 degrees Celsius or 99.5 degrees Fahrenheit. 10. Judgment by the study physician or the PI that the patient is not suitable for the study due to unforeseeable safety issues.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Post-testing (After Max. 12 Days) on the Part/Whole Identity Test (LFI Skills Battery) | Baseline and Post-testing (after max. 12 days) | This test measures the extent to which the participant employed a featural or holistic face recognition strategy. A sample face is presented, followed by a test face composed of either two whole faces or two face parts. |
| Change From Baseline to Post-testing (After Max. 12 Days) on the Reading the Mind in the Eyes Test (Child Version) | Baseline and Post-testing (after max. 12 days) | This is a test of emotion recognition. This test asks children to pick the best word out of four options to describe the mental state of a set of eyes. The test includes 28 photographs of eyes with both affective (e.g., upset) and cognitive (e.g., thoughtful) mental state words as choices. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes From Baseline to Post-testing (After Max. 12 Days) on the Happy Faces Measure of Social Attention | Baseline and Post-testing (after max. 12 days) | The Happy Faces task requires that participants look at a series of faces of men and women. Faces are presented on the screen one by one and children are asked just to look at the faces. Eye movements are measured with a Tobii x120 tabletop eye-tracker to evaluate participants' looking patterns towards the eyes versus the mouth region. |
Countries
United States
Participant flow
Pre-assignment details
The number of enrolled participants in the study was 36, but only 29 of those subjects were randomized. The 7 subjects who were not randomized did not meet study diagnostic or cognitive inclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Intranasal Oxytocin * Intranasal oxytocin (Trade name: Syntocinon)
* Pharmacological class: The pharmacologic and clinical properties of Syntocinon are identical with the naturally occurring hormone oxytocin, which is released from the posterior pituitary.
* Route of administration: Intranasal
* Planned exposure: Each participant will receive one dose of intranasal oxytocin (24 IU) per day for 5 days.
* One dose of 24 IU equals 6 spray puffs (3 puffs in each nostril).
* Oxytocin will be imported from Victoria Pharmacy Zurich- Switzerland.
Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period. | 14 |
| Intranasal Placebo * Intranasal placebo
* The placebo is identical to the oxytocin formulation with the exception of the active compound.
* Route of administration: Intranasal
* Planned exposure: Each participant will receive one dose of intranasal placebo per day for 5 days.
* One dose equals 6 spray puffs (3 puffs in each nostril).
* Placebo will be imported from Victoria Pharmacy Zurich- Switzerland.
Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period. | 13 |
| Total | 27 |
Baseline characteristics
| Characteristic | Intranasal Oxytocin | Intranasal Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 14 Participants | 13 Participants | 27 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 14 participants | 13 participants | 27 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 14 Participants | 13 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 16 | 12 / 13 |
| serious Total, serious adverse events | 0 / 16 | 0 / 13 |
Outcome results
Primary
Change From Baseline to Post-testing (After Max. 12 Days) on the Part/Whole Identity Test (LFI Skills Battery)
This test measures the extent to which the participant employed a featural or holistic face recognition strategy. A sample face is presented, followed by a test face composed of either two whole faces or two face parts.
Time frame: Baseline and Post-testing (after max. 12 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Oxytocin | Change From Baseline to Post-testing (After Max. 12 Days) on the Part/Whole Identity Test (LFI Skills Battery) | 3.30 change in percent correct | Standard Deviation 10.78 |
| Intranasal Placebo | Change From Baseline to Post-testing (After Max. 12 Days) on the Part/Whole Identity Test (LFI Skills Battery) | 3.17 change in percent correct | Standard Deviation 8.17 |
Primary
Change From Baseline to Post-testing (After Max. 12 Days) on the Reading the Mind in the Eyes Test (Child Version)
This is a test of emotion recognition. This test asks children to pick the best word out of four options to describe the mental state of a set of eyes. The test includes 28 photographs of eyes with both affective (e.g., upset) and cognitive (e.g., thoughtful) mental state words as choices.
Time frame: Baseline and Post-testing (after max. 12 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Oxytocin | Change From Baseline to Post-testing (After Max. 12 Days) on the Reading the Mind in the Eyes Test (Child Version) | 0.33 change in items correct | Standard Deviation 3.92 |
| Intranasal Placebo | Change From Baseline to Post-testing (After Max. 12 Days) on the Reading the Mind in the Eyes Test (Child Version) | 1.82 change in items correct | Standard Deviation 3.34 |
Secondary
Changes From Baseline to Post-testing (After Max. 12 Days) on the Happy Faces Measure of Social Attention
The Happy Faces task requires that participants look at a series of faces of men and women. Faces are presented on the screen one by one and children are asked just to look at the faces. Eye movements are measured with a Tobii x120 tabletop eye-tracker to evaluate participants' looking patterns towards the eyes versus the mouth region.
Time frame: Baseline and Post-testing (after max. 12 days)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intranasal Oxytocin | Changes From Baseline to Post-testing (After Max. 12 Days) on the Happy Faces Measure of Social Attention | looking to faces relative to full screen | .02 change in proportion of looking | Standard Deviation 0.18 |
| Intranasal Oxytocin | Changes From Baseline to Post-testing (After Max. 12 Days) on the Happy Faces Measure of Social Attention | looking to objects relative to full screen | -.03 change in proportion of looking | Standard Deviation 0.14 |
| Intranasal Placebo | Changes From Baseline to Post-testing (After Max. 12 Days) on the Happy Faces Measure of Social Attention | looking to faces relative to full screen | -0.05 change in proportion of looking | Standard Deviation 0.25 |
| Intranasal Placebo | Changes From Baseline to Post-testing (After Max. 12 Days) on the Happy Faces Measure of Social Attention | looking to objects relative to full screen | .08 change in proportion of looking | Standard Deviation 0.18 |