Back to resultsADDERALL 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
Primary Purpose
Attention Deficit Disorder With Hyperactivity
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Mixed salts of a single-entity amphetamine
Atomoxetine hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity
Eligibility 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
Sites / Locations
- Washington Neuropsychological Institute, LLC
Outcomes
Primary Outcome Measures
Overall Driving Safety Score derived by the driving simulator
Secondary Outcome Measures
Driving Safety Scores at individual time points
Cog-Screen Aviator Predictor Score, ADHD-RS, CGI, Self-rating of driving simulator performance questionnaire
AEs, laboratory screens, PE, vital signs, ECG
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00557960
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 25, 2004 (Actual)
Primary Completion Date
October 25, 2004 (Actual)
Study Completion Date
October 25, 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Mixed salts of a single-entity amphetamine
Other Intervention Name(s)
ADDERALL XR
Intervention Type
Drug
Intervention Name(s)
Atomoxetine hydrochloride
Other Intervention Name(s)
STRATTERA
Primary Outcome Measure Information:
Title
Overall Driving Safety Score derived by the driving simulator
Time Frame
Weeks 3 & 6
Secondary Outcome Measure Information:
Title
Driving Safety Scores at individual time points
Time Frame
2, 7, and 12 hours post-dose at Weeks 3 & 6
Title
Cog-Screen Aviator Predictor Score, ADHD-RS, CGI, Self-rating of driving simulator performance questionnaire
Time Frame
Weeks 3 & 6
Title
AEs, laboratory screens, PE, vital signs, ECG
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Washington Neuropsychological Institute, LLC
City
Washington
State/Province
District of Columbia
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18815438
Citation
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. doi: 10.1177/1087054708322986. Epub 2008 Sep 24.
Results Reference
result
Links:
URL
http://www.fda.gov/opacom/7alerts.html
Description
FDA Recall Information
Learn more about this trial
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
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