The purpose of this study is to determine whether SPD465 is safe and effective in the treatment of ADHD in young adult drivers after a duration of 16 hours.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Meridien Research
Tampa, Florida, United States
Simulated Driver Safety (DS) Score averaged over 3 driving assessments at one interim and one final visit.
Time frame: Interim visit = Week 3; Final visit = Week 7.
Interim & final visits: Attention-Deficit Hyperactivity Disorder Rating Scale - 4th Edition (ADHD-RS-IV)
Time frame: Interim visit = Week 3; Final visit = Week 7.
Interim & final visits: Clinical Global Impressions of Improvement (CGI-I)
Time frame: Interim visit = Week 3; Final visit = Week 7.
Interim & final visits: Self-Rating of Simulated Driver Safety (DS) Performance Questionnaire
Time frame: Post DS Testing - Interim visit = Week 3; Post DS Testing - Final visit = Week 7.
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