ADDERALL XR (Mixed Salts of a Single-entity Amphetamine) and STRATTERA ( Atomoxetine Hydrochloride) Compared to Placebo on Simulated Driving Safety and Performance and Cognitive Functioning in Adults With ADHD
Phase 3
Completed
- Conditions
- Attention Deficit Disorder With Hyperactivity
- Registration Number
- NCT00557960
- Lead Sponsor
- Shire
- Brief Summary
Evaluate the efficacy of treatment with ADDERALL XR and STRATTERA compared to placebo on simulated driving safety and performance of young adults with ADHD as measured by Driving Safety Scores derived by the Driving Simulator.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
- primary diagnosis of ADHD
- not naive to pharmacologic ADHD treatment
- valid driver's license with a minimum of 3 years driving experience
Exclusion Criteria
- recent history of drug dependence or substance use disorder
- any specific cardiac condition that would, in the opinion of the investigator, require exclusion
- history of seizure in last 2 years, tic disorder or Tourette's disorder
- female subject is pregnant or lactating
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Overall Driving Safety Score derived by the driving simulator Weeks 3 & 6
- Secondary Outcome Measures
Name Time Method AEs, laboratory screens, PE, vital signs, ECG 6 weeks Driving Safety Scores at individual time points 2, 7, and 12 hours post-dose at Weeks 3 & 6 Cog-Screen Aviator Predictor Score, ADHD-RS, CGI, Self-rating of driving simulator performance questionnaire Weeks 3 & 6
Trial Locations
- Locations (1)
Washington Neuropsychological Institute, LLC
🇺🇸Washington, District of Columbia, United States
Washington Neuropsychological Institute, LLC🇺🇸Washington, District of Columbia, United States