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 the participants sleep and how they perceive their quality of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
412
The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54.
Time frame: Baseline (following ADHD medication washout of 7-28 days)
The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54.
Time frame: Week 1
The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54.
Time frame: Week 2
The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54.
Time frame: Week 3
The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54.
Time frame: Week 4
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The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54.
Time frame: Week 5
The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54.
Time frame: Week 6
Clinical Global Impression of Improvement scale (CG(-I) - assessed at visits 1 through 6/Early Termination (ET)
Time frame: Weeks 1, 2, 3, 4, 5, & 6
Brown ADD Scale (BADDS) - completed at Baseline and 6/ET visits
Time frame: Baseline visit and weeks 1, 2, 3, 4, 5, & 6
Adult ADHD Impact Module (AIM-A)-completed at Baseline and 6/ET visits.
Time frame: Baseline visit and weeks 1, 2, 3, 4, 5, & 6
Pittsburgh Sleep Quality Index (PSQI) - taken at every visit from Baseline to study completion.
Time frame: Baseline visit and weeks 1, 2, 3, 4, 5, & 6