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:
Shire Development LLC
Information provided by:
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT00557960
First received: November 9, 2007
Last updated: December 10, 2010
Last verified: March 2009
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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:
Drug Information available for:
Methamphetamine hydrochloride
Amphetamine sulfate
Amphetamine
Methamphetamine
Sodium chloride
Atomoxetine hydrochloride
Atomoxetine
Adderall
U.S. FDA Resources
Further study details as provided by Shire Development LLC:
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
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 Development LLC
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 Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Amphetamine Methamphetamine Adderall Atomoxetine Central Nervous System Stimulants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Dopamine Uptake Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013