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Completed

NCT Number: NCT00150592

Safety, Tolerability and Efficacy of SPD503 in Treating ADHD in Children Aged 6-17

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.

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Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

SPD503 (Guanfacine HCl)

Drug

Placebo

Drug

Primary outcomes

  1. Change From Baseline in Choice Reaction Time (CRT) at 6 Weeks

    Time frame: 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 outcomes

  1. Change From Baseline in Digital Symbol Substitution Task/Coding Test (DSST/Coding) Scores at 6 Weeks in Age Category 8-17 Years

    Time frame: 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.

  2. Change From Baseline in DSST/Coding Scores at 6 Weeks in Age Category 6-7 Years

    Time frame: 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.

  3. Change From Baseline in Spatial Working Memory (SWM) Scores at 6 Weeks

    Time frame: 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.

  4. Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at 6 Weeks

    Time frame: 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.

  5. Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) at 6 Weeks

    Time frame: 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.

  6. Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Scores at 6 Weeks

    Time frame: 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.

  7. Change From Baseline in Pictorial Sleepiness Scale (PSS) Scores at 6 Weeks

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study title

A Phase II Study to Assess the Safety, Tolerability and Efficacy of SPD503 Administered to Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Sep 8, 2005
Registry last updated
Jun 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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