Improving Driving in Young People With Autism Spectrum Disorders

NCT03538431 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2018-P-000900
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder; ASD; Anxiety

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Buspirone

EXPERIMENTAL

These subjects will receive buspirone prior to engaging in the driving simulation.

Drug: Buspirone

Unmedicated

EXPERIMENTAL

These subjects will take no medication prior to engaging in the driving simulation

Drug: Buspirone

Interventions

Buspirone DRUG

Buspirone is an atypical anxiolytic medication.

Buspirone; Unmedicated

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females, ages 18-24, with a diagnosis of DSM-V Autism Spectrum Disorder
• Has a valid Driver's License

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Massachusetts Institute of Technology: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Anxiety Disorders

Interventions

Buspirone

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Joseph Biederman
• Organization: Massachusetts General Hospital

biederman@helix.mgh.harvard.edu

6177261743

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: May 29, 2018
• Study Start: October 31, 2018
• Primary Completion: December 16, 2019
• Study Completion: December 16, 2019
• Last Updated: March 18, 2021
• Results First Posted: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)