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

• Status: Completed
• Trial end date: 2004-10-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire
• Treatments: Adderall; Amphetamine; Atomoxetine Hydrochloride

Criteria

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