The purpose of this study is to assess the safety and effectiveness of SPD465 compared to placebo (a capsule with no medication in it) in the treatment of ADHD. The study will also look at how SPD465 affects sleep and how the participants perceive their quality of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
240
Change from Baseline in the ADHD-rating scale 4th Edition (ADHD-RS-IV) total score to the Endpoint assessment.
The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.
Time frame: Baseline, and the Endpoint (average of weeks 5, 6, 7).
Change from Baseline in the Clinical Global Impression of Improvement scale (CGI-I) to the Endpoint assessment.
The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.
Time frame: Baseline, and the Endpoint (average of weeks 5, 6, 7).
Change from Baseline in the Time-Sensitive ADHD Symptom Scale (TASS) score to the Endpoint assessment.
The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.
Time frame: Baseline, and the Endpoint (average of weeks 5, 6, 7).
Change from Baseline in the Brown Attention Deficit Disorder Scale (BADDS) to the Endpoint assessment
The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.
Time frame: Baseline, and the Endpoint (average of weeks 5, 6, 7).
Change in Baseline in the Adult ADHD Impact Module (AIM-A) score to the Endpoint assessment
The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.
Time frame: Baseline, and the Endpoint (average of weeks 5, 6, 7).
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 1
Time frame: Baseline and Week 1.
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 4
Time frame: Baseline and Week 4.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 7
Time frame: Baseline and Week 7.