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

Sponsor

Shire (Industry)

Overall Status

Completed

CT.gov ID

NCT00557960

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

4.5

Patients Per Site Per Month

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
Attention Deficit Disorder With Hyperactivity	Drug: Mixed salts of a single-entity amphetamine Drug: Atomoxetine hydrochloride	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 25 Years

Sexes Eligible for Study:

All

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