Intranasal Oxytocin and Learning in Autism
| Status: | Withdrawn |
|---|---|
| Conditions: | Neurology, Psychiatric, Psychiatric, Autism |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 12 - 17 |
| Updated: | 10/14/2018 |
| Start Date: | March 2014 |
| End Date: | March 2018 |
Promoting Social Perceptual Learning With Oxytocin in Autism
: The objective of this study is to determine the tolerability and therapeutic potential of
oxytocin in children and adolescents with Autism Spectrum Disorders (ASD) when paired with a
computer game intervention that is designed to enhance face perception skills. We designate
two measures as our primary outcomes, based on prior published work with these interventions,
and we propose a sample based on power analyses from these prior results. A second objective
of this study is to learn about the breadth of possible positive effects that this
combination therapy might have for children with ASD. To this end, we include a host of other
exploratory measures that assess aspects of social motivation and attention, social
perception, and social cognition. Thus, a second objective is to conduct a "signal finding"
study - to gather outcome data on a range of dependent variables that theoretically should be
related to oxytocin's effects on social processes, but for which there are no prior data. The
signal finding aspect of this study will provide the preliminary data needed to design a more
targeted follow up study.
oxytocin in children and adolescents with Autism Spectrum Disorders (ASD) when paired with a
computer game intervention that is designed to enhance face perception skills. We designate
two measures as our primary outcomes, based on prior published work with these interventions,
and we propose a sample based on power analyses from these prior results. A second objective
of this study is to learn about the breadth of possible positive effects that this
combination therapy might have for children with ASD. To this end, we include a host of other
exploratory measures that assess aspects of social motivation and attention, social
perception, and social cognition. Thus, a second objective is to conduct a "signal finding"
study - to gather outcome data on a range of dependent variables that theoretically should be
related to oxytocin's effects on social processes, but for which there are no prior data. The
signal finding aspect of this study will provide the preliminary data needed to design a more
targeted follow up study.
This is a double-blind placebo-controlled trial of intranasal oxytocin in 52 children and
adolescents with ASD. Diagnosis will be confirmed using Diagnostic and Statistical Manual
(DSM) criteria, supported by the Autism Diagnostic Interview and the Autism Diagnostic
Observation Schedule. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for
a 5 day period with concomitant game play of the FaceStation computer games, developed at
CHOP. Measures of social function and cognition will be administered before and after the
game play period. Two measures of social functioning will serve as our primary endpoints; all
other measures will be treated as exploratory variables, with significance testing corrected
for multiple comparisons.
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.
adolescents with ASD. Diagnosis will be confirmed using Diagnostic and Statistical Manual
(DSM) criteria, supported by the Autism Diagnostic Interview and the Autism Diagnostic
Observation Schedule. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for
a 5 day period with concomitant game play of the FaceStation computer games, developed at
CHOP. Measures of social function and cognition will be administered before and after the
game play period. Two measures of social functioning will serve as our primary endpoints; all
other measures will be treated as exploratory variables, with significance testing corrected
for multiple comparisons.
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.
Inclusion Criteria:
1. Subjects aged 12-17 years, Mental age ≥ 7 (as measured by an IQ test such as the
Differential Ability Scales II).
2. Gender: males
3. Diagnosis of an ASD
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
6. Study participant needs to be on 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 acquired neurological abnormality
affecting brain function and motor, sensory or higher cognitive functioning.
2. Patients with one or more of the following: HIV, HBV, 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., 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/P.I. (Suma Jacob, M.D,) that the patient is not
suitable for the study due to unforeseeable safety issues.
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