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| Name | Class |
|---|---|
| Massachusetts Institute of Technology | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buspirone | Experimental | These subjects will receive buspirone prior to engaging in the driving simulation. |
|
| Unmedicated | Experimental | These subjects will take no medication prior to engaging in the driving simulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buspirone | Drug | Buspirone is an atypical anxiolytic medication. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 6 weeks |
| Heart Rate | Hyperarousal will be measured by heart rate during participants' time in the driving simulation. | Up to 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Buspirone Before Simulation 1, Then no Buspirone Before Simulation 2 | These subjects will receive and be instructed to take the buspirone for the 2 days preceding their first driving simulation visit. They will not take buspirone before their 2nd driving simulation visit. Buspirone: Buspirone is an atypical anxiolytic medication. |
| FG001 | No Buspirone Before Simulation 1, Then Buspirone Before Simulation 2 | These subjects will receive and be instructed to take the buspirone for the 2 days preceding their second driving simulation visit. They will not take buspirone before their 1st driving simulation visit. Buspirone: Buspirone is an atypical anxiolytic medication. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Seconds | Up to 6 weeks |
|
Adverse event data was collected for each participant between the date the participant enrolled in the study and the date the participant completed the study. The precise time frame of this window differed by participant depending on their availability to schedule the driving simulations. On average, adverse event data were collected over a period of 7.2 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Buspirone | These subjects received buspirone either before driving simulation visit 1 or before driving simulation 2. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild allergic reaction to medication prescribed not related to the study | Immune system disorders | Non-systematic Assessment | The participant reported having a mild allergic reaction to vitamins B12 and D3 that were prescribed by the primary care physician. This was determined to be unrelated to the study drug. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joseph Biederman | Massachusetts General Hospital | 6177261743 | biederman@helix.mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 3, 2019 | Mar 17, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002065 | Buspirone |
| ID | Term |
|---|---|
| D013141 | Spiro Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | Unmedicated | These participants completed the driving simulation unmedicated. Subjects will receive buspirone before 1 of 2 driving simulation visits. Half of the participants in the study completed Simulation 1 on unmedicated, and the other half completed Simulation 2 on unmedicated. Buspirone: Buspirone is an atypical anxiolytic medication. |
|
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| Primary | Heart Rate | Hyperarousal will be measured by heart rate during participants' time in the driving simulation. | Posted | Mean | Standard Deviation | Beats Per Minute | Up to 6 weeks |
|
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|
| 0 |
| 26 |
| 0 |
| 26 |
| 5 |
| 26 |
| EG001 | Unmedicated | These subjects received no medication either before driving simulation visit 1 or before driving simulation 2. | 0 | 26 | 0 | 26 | 0 | 26 |
|
| Concussion | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | The subject reported receiving a concussion between enrolling in the study and medication driving simulation visit. The concussion healed prior to the drive. This was determined to be unrelated to the study |
|
| Chest Tightness, mild excitement, and nausea | Cardiac disorders | Non-systematic Assessment | Participant reported suffering from chest tightness, mild excitement, and nausea while taking the new medication. Chest tightness was possibly related, and excitement and nausea were related to the drug. All resolved 24 hours after onset. |
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| Mild nausea | Gastrointestinal disorders | Systematic Assessment | Participant endorsed nausea as a side effect of buspirone medication. This side effect was mild, expected, and related to the study drug. It resolved 24 hours after onset. |
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| Head Cold | Infections and infestations | Non-systematic Assessment | The subject reported having a head cold during the medication driving simulation visit and was not able to sleep. This event was considered mild and unrelated to the study drug, |
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| D010879 |
| Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D011083 | Polycyclic Compounds |