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.
Sponsor:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00557960
First received: November 9, 2007
Last updated: December 10, 2010
Last verified: March 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Shire:

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
Intervention Details:
    Drug: Mixed salts of a single-entity amphetamine
    Other Name: ADDERALL XR
    Drug: Atomoxetine hydrochloride
    Other Name: STRATTERA
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Gary G Kay, PhD Washington Neuropsychologica Institute, LLC
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00557960     History of Changes
Other Study ID Numbers: SLI381-316
Study First Received: November 9, 2007
Last Updated: December 10, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Disease
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Adderall
Amphetamine
Atomoxetine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Autonomic Agents
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sympathomimetics
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014