Attention Deficit Disorder With Hyperactivity
Conditions
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.
Interventions
DRUGNeutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate
Sponsors
Shire
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 4 | Baseline and Week 4. | — |
| Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 7 | Baseline and Week 7. | — |
| Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 1 | Baseline and Week 1. | — |
Outcome results
None listed