Efficacy and Safety of SPD465 in Adults With Moderately Symptomatic ADHD.
Phase 3
Completed
- Conditions
- Attention Deficit Disorder With Hyperactivity
- Registration Number
- NCT00152022
- Lead Sponsor
- Shire
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 412
Inclusion Criteria
- Primary diagnosis of ADHD
- Baseline ADHD-RS-IV score >= 32
- Non-pregnant females of childbearing potential must comply with contraceptive restrictions.
Exclusion Criteria
- Significantly underweight or morbidly obese
- Comorbid psychiatric diagnosis with significant symptoms such as Axis II disorders or severe Axis I disorders
- History of seizure, tic disorder, or a current diagnosis and/or family history of Tourette's Disorder
- Females who are pregnant or lactating
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) Week 6 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.
- Secondary Outcome Measures
Name Time Method Brown ADD Scale (BADDS) - completed at Baseline and 6/ET visits Baseline visit and weeks 1, 2, 3, 4, 5, & 6 Adult ADHD Impact Module (AIM-A)-completed at Baseline and 6/ET visits. Baseline visit and weeks 1, 2, 3, 4, 5, & 6 Pittsburgh Sleep Quality Index (PSQI) - taken at every visit from Baseline to study completion. Baseline visit and weeks 1, 2, 3, 4, 5, & 6 Clinical Global Impression of Improvement scale (CG(-I) - assessed at visits 1 through 6/Early Termination (ET) Weeks 1, 2, 3, 4, 5, & 6