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

Shire (Industry)
Overall Status
Completed ID

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Mixed salts of a single-entity amphetamine
  • Drug: Atomoxetine hydrochloride
Phase 3

Study Design

Study Type:
Actual Enrollment :
36 participants
Intervention Model:
Crossover Assignment
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
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)
Actual Study Start Date :
Feb 25, 2004
Actual Primary Completion Date :
Oct 25, 2004
Actual Study Completion Date :
Oct 25, 2004

Outcome Measures

Primary Outcome Measures

  1. Overall Driving Safety Score derived by the driving simulator [Weeks 3 & 6]

Secondary Outcome Measures

  1. Driving Safety Scores at individual time points [2, 7, and 12 hours post-dose at Weeks 3 & 6]

  2. Cog-Screen Aviator Predictor Score, ADHD-RS, CGI, Self-rating of driving simulator performance questionnaire [Weeks 3 & 6]

  3. AEs, laboratory screens, PE, vital signs, ECG [6 weeks]

Eligibility Criteria


Ages Eligible for Study:
19 Years to 25 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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

Contacts and Locations


Site City State Country Postal Code
1 Washington Neuropsychological Institute, LLC Washington District of Columbia United States

Sponsors and Collaborators

  • Shire


  • Study Director: Study Director, Takeda

Study Documents (Full-Text)

None provided.

More Information

Additional Information:


None provided.
Responsible Party:
Shire Identifier:
Other Study ID Numbers:
  • SLI381-316
First Posted:
Nov 14, 2007
Last Update Posted:
May 25, 2021
Last Verified:
May 1, 2021

Study Results

No Results Posted as of May 25, 2021