NCT00150579CompletedPhase 3
A Phase III, Randomized, Double-blind, Multi-center, Placebo-Controlled, Parallel-Group, Safety and Efficacy Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD).
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Shire
- Enrollment
- 240
- Primary Endpoint
- Change from Baseline in the ADHD-rating scale 4th Edition (ADHD-RS-IV) total score to the Endpoint assessment.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change from Baseline in the ADHD-rating scale 4th Edition (ADHD-RS-IV) total score to the Endpoint assessment.
Time Frame: 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 Outcomes
- 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).)
- 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).)
- 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).)
- 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).)
- Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 7(Baseline and Week 7.)
Investigators
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