Autism Spectrum Disorder
Conditions
Keywords
Autism Spectrum Disorder, ASD, Anxiety
Brief summary
This study will examine the effects of treatment with the anti-anxiety medicine buspirone on driving performance (eye tracking) in individuals with high-functioning autism spectrum disorder (HF-ASD). The study consists of an Assessment Visit at Massachusetts General Hospital (MGH), as well as two Driving Simulation visits that will take place at Massachusetts Institute of Technology (MIT). Subjects will be given buspirone and asked to take the medication for the two days preceding the Driving Simulation Visit.
Interventions
DRUGBuspirone
Buspirone is an atypical anxiolytic medication.
Sponsors
Massachusetts Institute of Technology
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
No
Inclusion criteria
* Males and females, ages 18-24, with a diagnosis of DSM-V Autism Spectrum Disorder * Has a valid Driver's License
Exclusion criteria
* Major sensorimotor handicaps (e.g. deafness, blindness) * Individuals who have never held a valid driver's license * Intellectual Deficiency (Verbal Comprehension Index \< 80) * Inadequate command of the English language * Subjects with any clinically meaningful medical or psychiatric condition as determined by the investigator * Individuals who are currently taking a monoamine oxidase inhibitor (MAOI) for any reason * Pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Driving Performance - Measured by Mean Off-Road Glance Duration | Up to 6 weeks | Driving performance will be analyzed using eye tracking in individuals with Autism Spectrum Disorder while on the anti-anxiety medication buspirone and while not on buspirone. Eye movement behavior (measured by glance duration) during the driving simulation was manually coded on a frame-by-frame basis from recorded video by trained coders for all cases where usable video recordings were available for both the medicated and non-medicated driving simulation sessions per participant. |
| Heart Rate | Up to 6 weeks | Hyperarousal will be measured by heart rate during participants' time in the driving simulation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Buspirone These participants took buspirone either before driving simulation 1 or before driving simulation 2. Those who took the medication before driving simulation visit 1 took no medication before visit 2, and those who took the medication before driving simulation visit 2 took no medication before driving simulation 1. This study is a crossover design. | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Buspirone |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants |
| Age, Continuous | 27.8 Years STANDARD_DEVIATION 8.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Region of Enrollment United States | 26 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 5 / 26 | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 |
Outcome results
Primary
Driving Performance - Measured by Mean Off-Road Glance Duration
Driving performance will be analyzed using eye tracking in individuals with Autism Spectrum Disorder while on the anti-anxiety medication buspirone and while not on buspirone. Eye movement behavior (measured by glance duration) during the driving simulation was manually coded on a frame-by-frame basis from recorded video by trained coders for all cases where usable video recordings were available for both the medicated and non-medicated driving simulation sessions per participant.
Time frame: Up to 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Buspirone | Driving Performance - Measured by Mean Off-Road Glance Duration | 0.85 Seconds | Standard Deviation 0.17 |
| Unmedicated | Driving Performance - Measured by Mean Off-Road Glance Duration | 0.90 Seconds | Standard Deviation 0.27 |
Primary
Heart Rate
Hyperarousal will be measured by heart rate during participants' time in the driving simulation.
Time frame: Up to 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Buspirone | Heart Rate | 81.78 Beats Per Minute | Standard Deviation 10.67 |
| Unmedicated | Heart Rate | 82.74 Beats Per Minute | Standard Deviation 11.7 |