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 - Full Text View

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.

Sponsored by:	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

MedlinePlus related topics:

Attention Deficit Hyperactivity Disorder Dietary Sodium Motor Vehicle Safety

ChemIDplus related topics:

Sodium chloride Atomoxetine Atomoxetine hydrochloride Amphetamine Amphetamine sulfate

U.S. FDA Resources

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)

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

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

Study ID Numbers:	SLI381-316
First Received:	November 9, 2007
Last Updated:	June 10, 2008
ClinicalTrials.gov Identifier:	NCT00557960
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms

Dopamine

Attention Deficit Disorder with Hyperactivity

Adderall

Mental Disorders

Mental Disorders Diagnosed in Childhood

Atomoxetine

Neurologic Manifestations

Attention Deficit and Disruptive Behavior Disorders

Hyperkinesis

Amphetamine

Dyskinesias

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Disease

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

Adrenergic Uptake Inhibitors

Sympathomimetics

Nervous System Diseases

Physiological Effects of Drugs

Central Nervous System Stimulants

Pharmacologic Actions

Pathologic Processes

Autonomic Agents

Therapeutic Uses

Dopamine Agents

Peripheral Nervous System Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on September 22, 2008