ASD, Autism
Conditions
Brief summary
This study examines the effects of a single dose of intranasal oxytocin (vs. placebo) on complex social cognition in adults with autism spectrum disorders.
Detailed description
Participants receive a one-time administration of 24-IU intranasal oxytocin (or placebo) and perform an empathic accuracy task, a novel and ecologically valid measure of complex social cognition, in conjunction with functional magnetic resonance imaging (fMRI). The investigators will investigate the effects of oxytocin (versus placebo) on the behavioral and neural correlates of empathic accuracy.
Interventions
DRUGSyntocinon
One dose of 24 IU (3 sprays/nostril)
DRUGPlacebo
Intranasal Placebo
Sponsors
Alexander Kolevzon
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
Both the participant and investigator are blind to drug condition.
Intervention model description
Participants are randomized to receive 24IU intranasal oxytocin or placebo on days separated by a minimum of 3 weeks. Randomization order to drug condition is counter-balanced.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* In good physical health * Meet criteria for ASD according to psychiatric interview using the Diagnostic and Statistic Manual, Fourth Edition (DSM-IV) * Must be a history of developmental delay * Must meet full criteria for ASD on the Autism Diagnostic Interview- Revised (ADI-R) on either the social or communication domains and within two points on other domain (only if parent available for interview) * Must meet full criteria for ASD on the Autism Diagnostic Observation Schedule- Generic (ADOS-G) on the social domain. Meeting for ASD on the communication domain and total domain is not necessary * Must have a verbal IQ greater than 75, as measured by the Wechsler Adult Intelligence Scale- Fourth Edition (WAIS- III). Intelligence testing performed at other sites or through another protocol at this site within the past year will also be accepted * Capability of performing experimental tasks (i.e. can read and understand task instructions, cooperate with procedures) * Informed consent and capacity * Female participants must remain on birth control for the duration of the study
Exclusion criteria
* Participants with any primary psychiatric diagnosis at screening * Participants with a medical history of neurological disease, including, but not limited to, epilepsy/seizure disorder (except simple febrile seizures), movement disorder, tuberous sclerosis, fragile X, and any other known genetic syndromes, or known abnormal MRI/structural lesion of the brain * Participants who are pregnant, who gave birth in the last six months, or who are currently breastfeeding * Participants with a medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being * Participants with evidence or history of malignancy or any significant hematological endocrine, cardiovascular (including rhythm disorder), respiratory, renal, hepatic, gastrointestinal disease, or other major medical conditions * Participants taking psychoactive medication(s) (e.g., stimulants, antidepressants, antipsychotics, antiepileptics, anxiolytics, clondine) * Participants who, in the Investigator's opinion, might not be suitable for the study * Participants who are involved in another study whose procedures could influence performance in the current study * Female participants who do not stay on birth control for the duration of the study * Participants who have a known contraindication to the MRI scan: including sever claustrophobia or any kind of metal implant in the body
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Empathic Accuracy Performance | 45 minutes after drug/placebo administration | Participants watch videos of targets describing positive and negative autobiographical events and provide continuous ratings of how positive-negative the target is feeling on a 9-point Likert scale. Empathic accuracy is operationalized as a timecourse correlation between perceiver inferences about target affect and targets' own affect ratings. |
| Fmri BOLD Response During Empathic Accuracy Task | 45 minutes after oxytocin/placebo administration | Images will be acquired using a 3.0 Tesla Siemens Allegra MRI scanner equipped to acquire gradient-echo, echoplanar T2\*-weighted images (EPI) with blood oxygenation level dependent (BOLD) contrast. Each volume will comprise 26 axial slices of 4.5mm thickness and a 3.5 x 3.5mm in-plane resolution, aligned along the AC-PC axis. Volumes will be acquired continuously every 2 seconds. Each run will begin with 5 'dummy' volumes, which will be discarded from further analyses. At the end of the scanning session, a T-1 weighted structural image will be acquired from each participant. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Syntocinon Then Placebo One dose 24IU (3 sprays/nostril) intranasal oxytocin, minimum of 3 weeks off, then Intranasal placebo | 14 |
| Placebo Then Syntocinon Intranasal Placebo, minimum of 3 weeks off, then 24IU (3 sprays/nostril) intranasal Syntocinon | 14 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 3 Weeks Wash Out | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Placebo Then Syntocinon | Total | Syntocinon Then Placebo |
|---|---|---|---|
| Age, Continuous | 27.5 years STANDARD_DEVIATION 6.7 | 29.3 years STANDARD_DEVIATION 7.7 | 30.7 years STANDARD_DEVIATION 8.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 23 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) White | 9 Participants | 20 Participants | 11 Participants |
| Sex: Female, Male Female | 3 Participants | 7 Participants | 4 Participants |
| Sex: Female, Male Male | 11 Participants | 21 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 28 |
| other Total, other adverse events | 8 / 28 | 10 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 |
Outcome results
Primary
Empathic Accuracy Performance
Participants watch videos of targets describing positive and negative autobiographical events and provide continuous ratings of how positive-negative the target is feeling on a 9-point Likert scale. Empathic accuracy is operationalized as a timecourse correlation between perceiver inferences about target affect and targets' own affect ratings.
Time frame: 45 minutes after drug/placebo administration
Population: The computer in the imaging suite crashed and the behavioral outcome data were not adequately backed up. The imaging data cannot be analyzed while pts were performing the EA task because without the behavioral data, the researchers do not know what pts were doing at each timepoint (it was an event related design). The researchers would not have the necessary information to know how to segment the data or what trial type (self/other/control) pts were doing at the various time points.
Primary
Fmri BOLD Response During Empathic Accuracy Task
Images will be acquired using a 3.0 Tesla Siemens Allegra MRI scanner equipped to acquire gradient-echo, echoplanar T2\*-weighted images (EPI) with blood oxygenation level dependent (BOLD) contrast. Each volume will comprise 26 axial slices of 4.5mm thickness and a 3.5 x 3.5mm in-plane resolution, aligned along the AC-PC axis. Volumes will be acquired continuously every 2 seconds. Each run will begin with 5 'dummy' volumes, which will be discarded from further analyses. At the end of the scanning session, a T-1 weighted structural image will be acquired from each participant.
Time frame: 45 minutes after oxytocin/placebo administration
Population: The computer in the imaging suite crashed and the behavioral outcome data were not adequately backed up. The imaging data cannot be analyzed while pts were performing the EA task because without the behavioral data, the researchers do not know what pts were doing at each timepoint (it was an event related design). The researchers would not have the necessary information to know how to segment the data or what trial type (self/other/control) pts were doing at the various time points.