The purpose of this study is to assess the safety and effectiveness of SPD465 in the treatment of ADHD. The study will also look at how SPD465 affects sleep.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
505
The evaluation of safety will be based on the occurrence of treatment emergent AEs and specific evaluation of vitals signs, ECG, laboratory and physical examination.
Time frame: Throughout the study period of approximately 20 months
ADHD-rating scale (ADHD-RS-IV) taken at the Visit 1 and all visits thereafter.
Time frame: Baseline, Weekly for 4 weeks, and then Monthly for 5 months.
Clinical Global Impression of Improvement scale assessed at Visits 1 through 15/Early Termination (ET).
Time frame: Baseline, Weekly for 4 weeks, and then Monthly for 5 months.
Pittsburgh Sleep Quality Index (PSQI) - assessed at Visits 1 through 15/ET.
Time frame: Baseline, Weekly for 4 weeks, and then Monthly for 5 months.
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