Safety, Tolerability and Efficacy of SPD503 in Treating ADHD in Children Aged 6-17
- Conditions
- Attention Deficit Disorder With Hyperactivity
- Interventions
- Drug: SPD503 (Guanfacine HCl)Drug: Placebo
- Registration Number
- NCT00150592
- Lead Sponsor
- Shire
- Brief Summary
The purpose of this study is to determine the effects of SPD503 compared to placebo on tasks of sustained attention in children and adolescents aged 6-17 diagnosed with ADHD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 182
- Subjects with a primary diagnosis of ADHD
- Minimum baseline visit ADHD-RS-IV score of 24 and a baseline CGI-S score =>4
- Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements
- Subject weighs > 55 lbs and is not morbidly overweight
- Subject has a comorbid psychiatric diagnosis (except ODD) with significant symptoms such as any severe comorbid Axis II disorders or severe Axis I disorders
- Subject has a history of seizure disorder
- Subject has any specific cardiac condition or family history of significant cardiac condition
- Subject is pregnant, lactating or within six month post-partum
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SPD503 (Guanfacine HCl) SPD503 (Guanfacine HCl) - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change From Baseline in Choice Reaction Time (CRT) at 6 Weeks Baseline and 6 weeks Choice reaction time (CRT) is a computerized assessment that trains the subject in holding down a press-pad and releasing the press-pad in response to stimuli presented on the screen. The task requires the subject to react as soon as a yellow dot appears in one of five locations, and the subject must respond by lifting their hand from the press-pad. This is the reaction time (RT) and ranges from 100 to 5000 msec. Lower scores indicate better performance.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Scores at 6 Weeks Baseline and 6 weeks The Pediatric Daytime Sleepiness Scale (PDSS) is an 8 question questionnaire scored on a scale from 0 (never) to 4 (always). Total scores range from 0 to 32, with increasing score reflecting greater sleepiness.
Change From Baseline in Digital Symbol Substitution Task/Coding Test (DSST/Coding) Scores at 6 Weeks in Age Category 8-17 Years Baseline and 6 weeks The Digital Symbol Substitution Task/Coding Test (DSST/Coding) assesses relative contributions of speed, memory, and visual scanning. Subjects are required to copy symbols that are paired with simple geometric shapes or numbers within a specific time. Scores range from 0-65 in age category 6-7 years and 0-199 in age category 8-17 years. Higher scores indicate better performance.
Change From Baseline in DSST/Coding Scores at 6 Weeks in Age Category 6-7 Years Baseline and 6 weeks The Digital Symbol Substitution Task/Coding Test (DSST/Coding) assesses relative contributions of speed, memory, and visual scanning. Subjects are required to copy symbols that are paired with simple geometric shapes or numbers within a specific time. Scores range from 0-65 in age category 6-7 years and 0-199 in age category 8-17 years. Higher scores indicate better performance.
Change From Baseline in Spatial Working Memory (SWM) Scores at 6 Weeks Baseline and 6 weeks The Spatial Working Memory (SWM) Test is a computerized assessment of working memory and strategy performance. The subject is required to find blue "tokens" in various displayed boxes and use the "tokens" to fill a column on the right side of the screen. Subjects can only find "tokens" in new boxes, therefore they must remember where previous "tokens" were found. SWM scores including number of between errors, number of within errors, and number of double errors range 0-800 and SWM strategy scores range 8-56. Lower scores indicate better performance.
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at 6 Weeks Baseline and 6 weeks Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) at 6 Weeks 6 weeks Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Change From Baseline in Pictorial Sleepiness Scale (PSS) Scores at 6 Weeks Baseline and 6 weeks The Pictorial Sleepiness Scale (PSS) scores range from 1 (far left wide awake face) to 5 (far right very sleepy face). Increasing score reflects greater sleepiness.