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

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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00557960

Enrollment

Registered

2007-11-14

Start date

2004-02-25

Completion date

2004-10-25

Last updated

2021-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Disorder With Hyperactivity

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.

Interventions

DRUGMixed salts of a single-entity amphetamine

DRUGAtomoxetine hydrochloride

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to 25 Years

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

Design outcomes

Primary

Measure	Time frame
Overall Driving Safety Score derived by the driving simulator	Weeks 3 & 6

Secondary

Measure	Time frame
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
AEs, laboratory screens, PE, vital signs, ECG	6 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026