The primary objective of the study is to evaluate the efficacy of SPD489 compared to placebo on executive function (self-regulation) behaviors in adults with ADHD who report clinically significant impairment of executive function behavior in their everyday environment, as measured by the self-report Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Global Executive Composite (GEC) T-score.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
161
Change From Baseline in Subject-reported Behavior Rating Inventory of Executive Function - Adult Version Global Executive Composite T-score (BRIEF-A GEC T) at up to 10 Weeks
BRIEF-A Global Executive Composite assesses behavioral aspects of executive function. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Time frame: Baseline and up to 10 weeks
Change From Baseline in Adult ADHD Impact Module (AIM-A) Multi-Item Scales Total Score at up to 10 Weeks
The AIM-A was developed to assess impact of core ADHD symptoms on daily functioning and quality of life. For multi-item scales, subjects respond to items using a Likert scale with responses ranging from 1 (strongly agree) to 5 (strongly disagree). Scores were computed by deriving the mean of the item sets and transforming the scale score on a continuum from 0 to 100 using a standard formula. Higher scores indicate a better quality of life.
Time frame: Baseline and up to 10 weeks
Change From Baseline in Informant-reported BRIEF-A T-scores at up to 10 Weeks
BRIEF-A is a validated 75-item questionnaire composed of three indexes (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Time frame: Baseline and up to10 weeks
Change From Baseline in Subject-reported BRIEF-A T-scores at up to 10 Weeks
BRIEF-A is a validated 75-item questionnaire composed of three indexes (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Global Executive Composite was reported as the Primary Outcome. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
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Clinical Study Centers, LLC
Little Rock, Arkansas, United States
Peninsula Research Assoc, Inc
Rolling Hills Estates, California, United States
PCSD Feighner Research
San Diego, California, United States
Florida Clinical Research Center, LLC
Bradenton, Florida, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, United States
Dr. George Joseph, MD and Associates PA
Jacksonville Beach, Florida, United States
Florida Clinical Research Center, LLC
Maitland, Florida, United States
CNS Healthcare
Orlando, Florida, United States
Janus Center For Psychiatric Research
West Palm Beach, Florida, United States
Atlanta Center For Medical Research
Atlanta, Georgia, United States
...and 29 more locations
Time frame: Baseline and up to 10 weeks
Change From Baseline in Subject-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks
BRIEF-A clinical subscales items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Time frame: Baseline and up to 10 weeks
Change From Baseline in Informant-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks
BRIEF-A clinical subscales items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Time frame: Baseline and up to 10 weeks
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) With Adult Prompts Total Score at up to 10 Weeks
The ADHD-RS 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. Lower scores indicate reduction in symptoms.
Time frame: Baseline and up to 10 weeks
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Time frame: Baseline
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at up to 10 Weeks
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Time frame: Up to 10 weeks post-dose
Percent of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at up to 10 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.
Time frame: Up to 10 weeks post-dose
Change From Baseline in AIM-A Multi-Item Scales of Living With ADHD and General Well-being Score at up to 10 Weeks
The AIM-A was developed to assess impact of core ADHD symptoms on daily functioning and quality of life. For multi-item scales, subjects respond to items using a Likert scale with responses ranging from 1 (strongly agree) to 5 (strongly disagree). Scores were computed by deriving the mean of the item sets and transforming the scale score on a continuum from 0 to 100 using a standard formula. Higher scores indicate a better quality of life.
Time frame: Baseline and up to 10 weeks
Change From Baseline in AIM-A Quality of Life Questions 1 and 4 Scores at up to 10 Weeks
Question 1: 'On a scale of 1 to 10, how would you rate the overall quality of life right now?' It is rated on a scale of 1 (worst) to 10 (best). Higher scores representing a more positive rating. Question 4: 'How much do you agree with this statement: Over the past few weeks, I've had more good days than bad days?' This is rated on a scale of 1 (strongly agree) to 5 (strongly disagree). Lower scores represent better quality of life.
Time frame: Baseline and up to 10 weeks
Change From Baseline in Conner's Adult ADHD Rating Scale-Observer: Short Version (CAARS-O:S) ADHD Index T-score at up to 10 Weeks
The CAARS-O:S is an assessment tool with prompts provided to an observer who describes ADHD-related symptoms in an adult subject. The 26-item scale is scored on a 4-point scale from 0 (not at all) to 3 (very much, very frequently). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Time frame: Baseline and up to 10 weeks
Change From Baseline in CAARS-O:S Factor-derived Subscale T-scores at up to 10 Weeks
The CAARS-O:S is an assessment tool with prompts provided to an observer who describes ADHD-related symptoms in an adult subject. The 26-item scale is scored on a 4-point scale from 0 (not at all) to 3 (very much, very frequently). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Time frame: Baseline and up to 10 weeks
Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Total Score at up to 10 Weeks
AAQoL is a validated 29-item scale consisting of 4 subscales. The AAQoL yields a total score and 4 subscale scores. Subjects rate each item on a 5-point Likert scale ranging from 1 (not at all/never) to 5 (extremely/very often). These scores are then transformed to a 0-100 point scale with higher scores indicating better quality of life.
Time frame: Baseline and up to 10 weeks