Effect of Vyvanse on Driving in Young Adults With ADHD

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to assess the benefice of Vyvanse on the factors that cause impairments in driving behavior in individuals with ADHD using a driving simulation aimed at examining the factors that cause impairments in driving behavior in individuals with ADHD such as driving speed, collision risk, and visual attention of 60 young drivers (ages 18-24) with ADHD. We hypothesize: 1.) young adults with ADHD treated with Vyvanse will show lower velocity (speed) scores and spend less time driving over the posted speed limit in the driving simulation when compared to subjects taking a placebo; 2.) young adults with ADHD treated with Vyvanse will show a lesser likelihood to collide with a suddenly appearing peripheral object, less difficulty maintaining the vehicle within their lane, and a lesser likelihood of driving through stop signs and solid red traffic lights without slowing down when compared to subjects taking a placebo; and 3.) young adults with ADHD treated with Vyvanse will exhibit more focused visual attention on details in the visual field when compared to subjects taking a placebo while driving. In addition, young adults with ADHD treated with Vyvanse will exhibit less visual tunneling and shorter off-road glances when compared to subjects taking a placebo.

Official Title
-----------------
The Effects of Vyvanse on the Driving Performance of Young Adults With ADHD: A Randomized, Double-Blind, Placebo-Controlled Study

Conditions
-----------------
Attention Deficit/Hyperactivity Disorder(ADHD)

Intervention / Treatment
-----------------
* Drug: Vyvanse
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female outpatients, aged 18-24 years. Subjects meeting full criteria for the diagnosis of DSM-IV Attention Deficit Hyperactivity Disorder (ADHD), with onset of symptoms in childhood and persistence of impairing symptoms into adulthood as determined by clinical evaluation and/or ADHD module of structured diagnostic interview, completed by the study clinician. Absence of pharmacological treatment for ADHD for the past month. Exclusion Criteria: Any other current psychiatric or medical condition determined to be clinically significant. Current use of psychotropics or any medication with clinically significant CNS effects. Individuals who have never held a valid driver's license. Mental retardation (IQ < 80). Individuals with a history of substance dependence or abuse within the past 6 months. Pregnant or nursing females. Known hypersensitivity to Vyvanse or amphetamines. Subjects with pre-existing structural cardiac abnormalities. Clinically significant abnormal screening values including: Laboratory values determined to be clinically significant. Consistent readings of hypertension (>140/90) during screening period (including screening and baseline visits), defined as two or more readings (each being the average of three measurements) at a single visit with systolic blood pressure, SBP > 140 and/or diastolic blood pressure, DBP, > 90, and confirmed by manual reading. Subjects with isolated incidences (of triplicate average BP) of SBP > 140 and/or DBP > 90 at baseline/week 0 visit, confirmed by manual reading, which are determined to be clinically significant. Subjects with a clinically significant abnormality according to cardiology consultation (ECGs with clinically concerning intervals including PR, QTC, QRS, will be reviewed by cardiology).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 24 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vyvanse<br>Patients may be randomized to the active comparator arm. Participants randomized to this arm will receive 30, 50, or 70mg Vyvanse daily. | Drug: Vyvanse<br>* Vyvanse 30, 50, or 70 mg daily<br>* Other names: Lisdexamfetamine;|
| Placebo Comparator: Placebo<br>Patients may be randomized to the placebo comparator arm. Those randomized to this arm will receive 30, 50, or 70mg placebo daily. | Drug: Placebo<br>* Placebo 30, 50, 70 mg daily<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants Experiencing Collisions During Surprise Events in Driving Simulator | Initial results from a one hour driving simulation in the MIT AgeLab Driving Simulator as compared to second session in the simulator following a 6-week trial on Lisdexamfetamine or placebo. During the simulation, surprise events, designed to test the participant's attention and driving, occurred. This outcome presents the difference in number of collisions experience by individuals treated with Vyvanse or Placebo. | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADHD, young adults, driving, Vyvanse, lisdexamfetamine