Efficacy and Safety of SPD465 in Adults With ADHD
Phase 3
Completed
- Conditions
- Attention Deficit Disorder With Hyperactivity
- Registration Number
- NCT00150579
- 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 sleep and how the participants perceive their quality of life.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
Inclusion Criteria
- Primary diagnosis of ADHD
- Baseline ADHD-RS-IV score >= 24
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from Baseline in the ADHD-rating scale 4th Edition (ADHD-RS-IV) total score to the Endpoint assessment. Baseline, and the Endpoint (average of weeks 5, 6, 7). The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.
- Secondary Outcome Measures
Name Time Method Change from Baseline in the Time-Sensitive ADHD Symptom Scale (TASS) score to the Endpoint assessment. Baseline, and the Endpoint (average of weeks 5, 6, 7). The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 4 Baseline and Week 4. Change from Baseline in the Clinical Global Impression of Improvement scale (CGI-I) to the Endpoint assessment. Baseline, and the Endpoint (average of weeks 5, 6, 7). The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.
Change in Baseline in the Adult ADHD Impact Module (AIM-A) score to the Endpoint assessment Baseline, and the Endpoint (average of weeks 5, 6, 7). The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 1 Baseline and Week 1. Change from Baseline in the Brown Attention Deficit Disorder Scale (BADDS) to the Endpoint assessment Baseline, and the Endpoint (average of weeks 5, 6, 7). The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 7 Baseline and Week 7.