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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00557960
Recruitment Status : Completed
First Posted : November 14, 2007
Last Update Posted : December 13, 2010
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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

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Study Type : Interventional  (Clinical Trial)
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)
Study Start Date : February 2004
Actual Study Completion Date : October 2004

Intervention Details:
  • Drug: Mixed salts of a single-entity amphetamine
    Other Name: ADDERALL XR
  • Drug: Atomoxetine hydrochloride
    Other Name: STRATTERA

Primary Outcome Measures :
  1. Overall Driving Safety Score derived by the driving simulator [ Time Frame: Weeks 3 & 6 ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00557960

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United States, District of Columbia
Washington Neuropsychological Institute, LLC
Washington, District of Columbia, United States
Sponsors and Collaborators
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Principal Investigator: Gary G Kay, PhD Washington Neuropsychologica Institute, LLC

Additional Information:
Publications of Results:
Layout table for additonal information Identifier: NCT00557960     History of Changes
Other Study ID Numbers: SLI381-316
First Posted: November 14, 2007    Key Record Dates
Last Update Posted: December 13, 2010
Last Verified: March 2009

Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Central Nervous System Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors