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Completed

NCT Number: NCT00557960

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

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.

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Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

19 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Washington Neuropsychological Institute, LLC

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mixed salts of a single-entity amphetamine

Drug

Other names: ADDERALL XR

Atomoxetine Hydrochloride

Drug

Other names: STRATTERA

Primary outcomes

  1. Overall Driving Safety Score derived by the driving simulator

    Time frame: Weeks 3 & 6

Secondary outcomes

  1. Driving Safety Scores at individual time points

    Time frame: 2, 7, and 12 hours post-dose at Weeks 3 & 6

  2. Cog-Screen Aviator Predictor Score, ADHD-RS, CGI, Self-rating of driving simulator performance questionnaire

    Time frame: Weeks 3 & 6

  3. AEs, laboratory screens, PE, vital signs, ECG

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study 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)

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Nov 14, 2007
Registry last updated
May 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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