Official Title: “A Phase IIIb Study to Evaluate the Efficacy and Time Course of Treatment With ADDERALL XR and STRATTERA Compared to Placebo on Simulated Driving Safety and Performance and Cognitive Functioning in Adults With Attention Deficit Hyperactivity Disorder (ADHD)”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Mixed salts of a single-entity amphetamine
• Drug: Atomoxetine hydrochloride

Primary Measures

• Overall Driving Safety Score derived by the driving simulator
  • Time Frame: Weeks 3 & 6
    Safety Issue?: No

Secondary Measures

• Driving Safety Scores at individual time points
  • Time Frame: 2, 7, and 12 hours post-dose at Weeks 3 & 6
    Safety Issue?: No
• Cog-Screen Aviator Predictor Score, ADHD-RS, CGI, Self-rating of driving simulator performance questionnaire
  • Time Frame: Weeks 3 & 6
    Safety Issue?: No
• AEs, laboratory screens, PE, vital signs, ECG
  • Time Frame: 6 weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 19 Years

Maximum Age for this Clinical Trial: 25 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Shire Pharmaceutical Development

Overall Clinical Trial Officials and Contacts

Gary G Kay, PhD Principal Investigator Washington Neuropsychologica Institute, LLC  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00557960

Study ID Number: SLI381-316

ClinicalTrials.gov Identifier: NCT00557960

Health Authority: United States: Food and Drug Administration

FDA Recall Information

FDA Medical Product Safety Alerts

FDA-approved Label

Synopsis of Study Results