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

Status and phase: Completed; Phase 3

Conditions: Attention Deficit Disorder With Hyperactivity

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00557960

SLI381-316

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 19 to 25 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind