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

Shire36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Attention Deficit Disorder With Hyperactivity

Interventions

Mixed salts of a single-entity amphetamineDRUG

Atomoxetine hydrochlorideDRUG

Eligibility

Sex: ALLMin age: 19 YearsMax age: 25 Years

Medical Language ↔ Plain English

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

Locations (1)

Washington Neuropsychological Institute, LLC

Washington D.C., District of Columbia, United States

Outcomes

Primary Outcomes

Overall Driving Safety Score derived by the driving simulator

Time frame: Weeks 3 & 6

Secondary Outcomes

Driving Safety Scores at individual time points

Time frame: 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

Time frame: Weeks 3 & 6

AEs, laboratory screens, PE, vital signs, ECG

Time frame: 6 weeks

Data from ClinicalTrials.gov

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