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

This study has been completed.

First Received: November 9, 2007 Last Updated: April 2, 2009 History of Changes

Sponsor:	Shire Pharmaceutical Development
Information provided by:	Shire Pharmaceutical Development
ClinicalTrials.gov Identifier:	NCT00557960

Purpose

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
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)

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder Dietary Sodium Methamphetamine Motor Vehicle Safety

Drug Information available for: Methamphetamine hydrochloride Amphetamine sulfate Atomoxetine hydrochloride Atomoxetine Amphetamine Methamphetamine Sodium chloride

U.S. FDA Resources

Further study details as provided by Shire Pharmaceutical Development:

Primary Outcome Measures:

Overall Driving Safety Score derived by the driving simulator [ Time Frame: Weeks 3 & 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Driving Safety Scores at individual time points [ Time Frame: 2, 7, and 12 hours post-dose at Weeks 3 & 6 ] [ Designated as safety issue: No ]
Cog-Screen Aviator Predictor Score, ADHD-RS, CGI, Self-rating of driving simulator performance questionnaire [ Time Frame: Weeks 3 & 6 ] [ Designated as safety issue: No ]
AEs, laboratory screens, PE, vital signs, ECG [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	36
Study Start Date:	February 2004
Study Completion Date:	October 2004

Eligibility

Ages Eligible for Study:	19 Years to 25 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00557960

Locations

United States, District of Columbia
Washington Neuropsychological Institute, LLC
Washington, District of Columbia, United States

Sponsors and Collaborators

Shire Pharmaceutical Development

Investigators

Principal Investigator:

Gary G Kay, PhD

Washington Neuropsychologica Institute, LLC

More Information

Additional Information:

FDA Recall Information This link exits the ClinicalTrials.gov site

FDA Medical Product Safety Alerts This link exits the ClinicalTrials.gov site

FDA-approved Label This link exits the ClinicalTrials.gov site

Synopsis of Study Results This link exits the ClinicalTrials.gov site

Publications:

Kay GG, Michaels MA, Pakull B. Simulated driving changes in young adults with ADHD receiving mixed amphetamine salts extended release and atomoxetine. J Atten Disord. 2009 Jan;12(4):316-29. Epub 2008 Sep 24.

Study ID Numbers:	SLI381-316
Study First Received:	November 9, 2007
Last Updated:	April 2, 2009
ClinicalTrials.gov Identifier:	NCT00557960 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Adderall
Physiological Effects of Drugs
Atomoxetine
Signs and Symptoms
Pathologic Processes
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Therapeutic Uses
Mental Disorders Diagnosed in Childhood

Hyperkinesis
Disease
Sympathomimetics
Nervous System Diseases
Attention Deficit and Disruptive Behavior Disorders
Central Nervous System Stimulants
Dyskinesias
Pharmacologic Actions
Methamphetamine
Autonomic Agents
Neurologic Manifestations
Amphetamine
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010