Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Change from baseline in Adult ADHD Self-Report Scale (v1.1) Symptoms Checklist (ASRSv1.1-SC) Total score by visit. |
The Adult ADHD Self-Report Scale (v1.1) Symptoms Checklist (ASRSv1.1-SC) is an ADHD-specific rating scale designed and validated to assess self-ratings of current ADHD symptomatology in adults. The ASRSv1.1-SC consists of 18 items that directly correspond to the 18 symptoms of ADHD per the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). The scale is subdivided into two subscales: Inattention (IA; 9 items) and Hyperactivity/Impulsivity (HI; 9 items). The subject rates the frequency of each item on a 5-point scale, where 0=never, 1=rarely, 2=sometimes, 3=often, and 4=very often. Subscale scores can range from 0 to 9 points, a score of = 6 points on either subscale is considered symptomatic. The ASRSv1.1-SC Total score is the sum of the number of points for all 18 items and can range from 0 to 18 points. Post-baseline raw Total scores are converted to a change from baseline Total score. A lower change from baseline Total Score (<0) represents a better outcome. |
Baseline and Week 4, 9, and 14 |
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| Other |
Change from baseline in the Adult ADHD Self-Report Scale (v1.1) Symptoms Checklist (ASRSv1.1-SC) Inattention and Hyperactivity/Impulsivity Subscale scores by visit. |
The Adult ADHD Self-Report Scale (v1.1) Symptoms Checklist (ASRSv1.1-SC) is an ADHD-specific rating scale designed and validated to assess self-ratings of current ADHD symptomatology in adults. The ASRSv1.1-SC consists of 18 items that directly correspond to the 18 symptoms of ADHD per the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). The scale is subdivided into two subscales: Inattention (IA; 9 items) and Hyperactivity/Impulsivity (HI; 9 items). The subject rates the frequency of each item on a 5-point scale, where 0=never, 1=rarely, 2=sometimes, and 3=often, and 4=very often. Subscale scores can range from 0 to 9 points, where a score of = 6 points on the IA or HI subscale is considered symptomatic. Post-baseline Subscale scores are converted to a change from baseline Subscale score. A lower change from baseline Subscale Score (<0) represents a better outcome. |
Baseline and Week 4, 9, and 14 |
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| Other |
Change from baseline in the Clinical Global Impression of Severity (CGI-S) score by visit |
The Clinical Global Impression of Severity (CGI-S) scale is a single item clinician-rated assessment of the severity of subject's condition (ADHD symptoms) in relation to the clinician's total experience with patients with ADHD. The CGI-S is evaluated on a 7-point scale with 1 = Asymptomatic, no symptoms; 2 = Borderline, 3 = Mild, 4 = Moderate, 5 = Marked, 6 = Severe, and 7 = Among the most extreme (the higher the score, the more severe the symptoms). Post-baseline (raw) CGI-S scores are converted to a change from baseline score. A lower change from baseline CGI-S score (<0) represents a better outcome. |
Baseline and Week 4, 9, and 14 |
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| Other |
The Clinical Global Impression of Change (CGI-C) score by visit |
The Clinical Global Impression of Change (CGI-C) scale is a single item clinician-rated assessment of how much the subject's condition (ADHD) has improved, worsened or has not changed relative to his/her baseline state prior to the beginning of treatment. The CGI-C is rated on a 7-point scale from 1 to 7, where 1 = "very much improved", 2 = "much improved", 3 = "minimally improved", 4 = "no change", 5 = "minimally worse", 6 = "much worse", and 7 = "very much worse". A CGI-C score <4 represents a better outcome. |
Week 4, 9, and 14 |
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| Other |
Change from baseline in the Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score at Week 14/End of Study |
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item investigator-rated diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders and is designed to be sensitive to changes elicited by treatment. A Structured Interview Guide for the MADRS (SIGMA) was developed to improve inter- and intra-rater consistency and improve reliability. The clinician rates each of the 10 items (symptoms) on a 7-point scale [0-6 continuum, where 0=no abnormality to 6=severe]. The sum of the ratings of all 10 items yields the raw Total score (range: 0-60; the higher the Total score, the more severe the depression symptoms). The post-baseline raw Total score is converted to a change from baseline Total score. A lower change from baseline Total Score (<0) represents a better outcome. |
Baseline and Week 14 |
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| Other |
Change from baseline in Patient Health Questionnaire 8-item (PHQ-8) Total Score by visit |
The Patient Health Questionnaire 8-item (PHQ-8) is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression per diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders. The PHQ-8 has been validated as a diagnostic and severity measure for depressive disorders in large clinical studies. The patient rates each item on 4-point scale (0-3), where 0 = not at all; 1 = several days; 2 = more than half the days; and 3 = nearly every day). The sum of the ratings of all 8 items yields the raw Total score (range: 0-24; the higher the Total score, the more severe the depression symptoms). The post-baseline raw Total score is converted to a change from baseline Total score. A lower change from baseline Total Score (<0) represents a better outcome. |
Baseline and Week 4, 9, and 14 |
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| Other |
Change from baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Week 14 |
The Hamilton Anxiety Scale (HAM-A) is a 14-item investigator-rated scale developed to assess/measure the severity of an individual's anxiety. The HAM-A has been used to assess severity of anxiety in children, adolescents, and adults in both clinical and research settings. A Structured Interview Guide for the HAM-A (SIGH-A) was developed to improve inter- and intra-rater consistency and improve reliability. The clinician rates each of the 14 items on a 5-point scale (0-4), where 0 = Not present, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very severe. The sum of the ratings of all 14 items yields the raw Total score (range: 0-56; the higher the Total score, the more severe the symptoms of anxiety). The post-baseline raw Total score is converted to a change from baseline Total score. A lower change from baseline Total Score (<0) represents a better outcome. |
Baseline and Week 14 |
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| Other |
Change from baseline in General Anxiety Disorder 7-item (GAD-7) Total Score by visit |
The Generalized Anxiety Disorder 7-Item (GAD-7) is a self-reported 7-item questionnaire for screening and measuring the severity of generalized anxiety disorder. The subject rates each item on 4-point scale (0-3), where 0 = "Not at all", 1 = "Several days", 2 = "Over half the days", and 3 = "Nearly every day". The sum of the 7 items yields a raw GAD-7 Total score (range between 0 to 21); the higher the Total score, the more severe the symptoms of anxiety. Post-baseline raw Total scores are converted to a change from baseline Total score. A lower change from baseline Total score (<0) represents a better outcome. |
Baseline and Week 4, 9, and 14 |
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| Other |
Change from baseline in the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Global Executive Composite (GEC) T-score at Week 14 (End of Study) |
The Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) is a 75-item self-rating scale that assesses overall functioning (GEC) and 9 non-overlapping scales among 2 summary index scales (Metacognition Index [MI] and Behavioral Regulation Index [BRI]) that assess aspects of executive function and problems with self-regulation from the perspective of the individual. Subjects rate each item on a 3-point scale (1=Never, 2=Sometimes, or 3=Often) based on their experience in past month. The sum of 70 items yields the GEC raw score (range: 70-210), which is converted to a T-score (normative population mean=50 and standard deviation=10; T-score = 65 is considered abnormally elevated). The post-baseline GEC T-score is converted to a change from baseline T-score. A lower change from baseline GEC T-score (<0) represents a better outcome. |
Baseline and Week 14 |
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| Other |
Change from baseline in the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Behavioral Regulation Index (BRI) T-score at Week 14 (End of Study) |
The Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) is a 75-item self-rating scale that assesses overall functioning and 9 non-overlapping scales among 2 summary index scales, the Metacognition Index (MI) and the Behavioral Regulation Index (BRI). The BRI captures the ability to maintain appropriate regulatory control of one's own behavior and emotional responses. Subjects rate each item on a 3-point scale (1=Never, 2=Sometimes, or 3=Often) based on their experience in past month. The sum of 30 items yields the BRI raw score (range: 30-90), which is converted to a T-score (normative population mean=50 and standard deviation=10; T-score = 65 is considered abnormally elevated). The post-baseline BRI T-score is converted to a change from baseline T-score. A lower change from baseline BRI T-score (<0) represents a better outcome. |
Baseline and Week 14 |
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| Other |
Change from baseline in the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Metacognition Index (MI) T-score at Week 14 (End of Study) |
The Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) is a 75-item self-rating scale that assesses overall functioning and 9 non-overlapping scales among 2 summary index scales, the Metacognition Index (MI) and the Behavioral Regulation Index (BRI). MI reflects individual's ability to problem solve (includes initiate activity, generate ideas, sustain working memory, plan/organize approaches, monitor success/failure, and organize materials/environment). Subjects rate each item on a 3-point scale (1=Never, 2=Sometimes, or 3=Often) based on their experience in past month. The sum of 40 items yields the MI raw score (range: 40-120), which is converted to a T-score (normative population mean=50 and standard deviation=10; T-score = 65 is considered abnormally elevated). The post-baseline MI T-score is converted to a change from baseline T-score. A lower change from baseline MI T-score (<0) represents a better outcome. |
Baseline and Week 14 |
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| Other |
Change from baseline in the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) "Inhibit" scale T-score at Week 14 (End of Study) |
The Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) is a 75-item self-rating scale that assesses overall functioning and 9 non-overlapping scales among 2 summary index scales. The "Inhibit" scale is one of four Behavioral Regulation Index-related scales; it captures the ability to control impulses and appropriately stop verbal, attentional, and physical behavior at the proper time. Subject's rate each item on a 3-point scale (1=Never, 2=Sometimes, or 3=Often) based on their experience in past month. The sum of 8 items yields the "Inhibit" raw score (range: 8-24), which is converted to a T-score (normative population mean=50 and standard deviation=10; T-score = 65 is considered abnormally elevated). The post-baseline T-score is converted to a change from baseline (CFB) T-score. A lower CFB "Inhibit" T-score (<0) represents a better outcome. |
Baseline and Week 14 |
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| Other |
Change from baseline in the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) "Shift" scale T-score at Week 14 (End of Study) |
The Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) is a 75-item self-rating scale that assesses overall functioning and 9 non-overlapping scales among 2 summary index scales. The "Shift" scale is one of four Behavioral Regulation Index-related scales; it captures one's ability to move freely from one situation/activity/ aspect of a problem to another and think flexibly to aid problem-solving. Subjects rate each item on a 3-point scale (1=Never, 2=Sometimes, or 3=Often) based on their experience in past month. The sum of 6 items yields the "Shift" raw score (range: 6-18), which is converted to a T-score (normative population mean=50 and standard deviation=10; T-score = 65 is considered abnormally elevated). The Post-baseline T-score is converted to a change from baseline (CFB) T-score. A lower CFB "Shift" T-score (<0) represents a better outcome. |
Baseline and Week 14 |
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| Other |
Change from baseline in the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) "Emotional Control" scale T-score at Week 14 (End of Study) |
The Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) is a 75-item self-rating scale that assesses overall functioning and 9 non-overlapping scales among 2 summary index scales. The "Emotional Control" scale is one of four Behavioral Regulation Index-related scales; it captures an individual's ability to modulate their emotional responses appropriately. Subjects rate each item on a 3-point scale (1=Never, 2=Sometimes, or 3=Often) based on their experience in past month. The sum of 10 items yields the "Emotional Control" raw score (range: 10-30), which is converted to a T-score (normative population mean=50 and standard deviation=10; T-score = 65 is considered abnormally elevated). The post-baseline T-score is converted to a change from baseline (CFB) T-score. A lower CFB "Emotional Control" T-score (<0) represents a better outcome. |
Baseline and Week 14 |
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| Other |
Change from baseline in the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) "Self-Monitor" scale T-score at Week 14 (End of Study) |
The Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) is a 75-item self-rating scale that assesses overall functioning and 9 non-overlapping scales among 2 summary index scales. The "Self-Monitor" scale is one of four Behavioral Regulation Index-related scales; it reflects an individual's ability to recognize the effect of their own behavior on others. The subject rates each item on a 3-point scale (1=Never, 2=Sometimes, or 3=Often) based on their experience in past month. The sum of 6 items yields the "Self-Monitor" raw score (range: 6-18), which is converted to a T-score (normative population mean=50 and standard deviation=10; T-score = 65 is considered abnormally elevated). The post-baseline T-score is converted to a change from baseline (CFB) T-score. A lower CFB "Self-Monitor" T-score (<0) represents a better outcome. |
Baseline and Week 14 |
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| Other |
Change from baseline in the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) "Initiate" scale T-score at Week 14 (End of Study) |
The Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) is a 75-item self-rating scale that assesses overall functioning and 9 non-overlapping scales among 2 summary index scales. The "Initiate" scale is one of five Metacognition Index-related scales; it captures an individual's ability to begin a task or activity without external prompting and to independently generate ideas. Subjects rate each item on a 3-point scale (1=Never, 2=Sometimes, or 3=Often) based on their experience in past month. The sum of 8 items yields the "Initiate" scale raw score (range: 8-24), which is converted to a T-score (normative population mean=50 and standard deviation=10; T-score = 65 is considered abnormally elevated). The post-baseline T-score is converted to a change from baseline (CFB) T-score. A lower CFB "Initiate" T-score (<0) represents a better outcome. |
Baseline and Week 14 |
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| Other |
Change from baseline in the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) "Working Memory" scale T-score at Week 14 (End of Study) |
The Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) is a 75-item self-rating scale that assesses overall functioning and 9 non-overlapping scales among 2 summary index scales. The "Working Memory" scale is one of five Metacognition Index-related scales; it captures one's ability to hold information in mind in order to complete a task and stay with, or stick to, an activity. Subjects rate each item on a 3-point scale (1=Never, 2=Sometimes, 3=Often) based on their experience in past month. The sum of 8 items yields the "Working Memory" raw score (range: 8-24), which is converted to a T-score (normative population mean=50 and standard deviation=10; T-score =65 is considered abnormally elevated). Post-baseline T-scores are converted to a change from baseline (CFB) T-score. A lower CFB "Working Memory" T-score (<0) represents a better outcome. |
Baseline and Week 14 |
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| Other |
Change from baseline in the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) "Plan/Organize" scale T-score at Week 14 (End of Study) |
The Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) is a 75-item self-rating scale that assesses overall functioning and 9 non-overlapping scales among 2 summary index scales. The "Plan/Organize" scale is one of five Metacognition Index-related scales; captures an individual's ability to anticipate events, set goals, pre-plan, organize, and carry out tasks systematically. Subjects rate each item on a 3-point scale (1=Never, 2=Sometimes, 3=Often) based on their experience in past month. The sum of 10 items yields the "Plan/Organize" raw score (range: 10-30), which is converted to a T-score (normative population mean=50 and standard deviation=10; T-score =65 is considered abnormally elevated). The post-baseline T-score is converted to a change from baseline (CFB) T-score. A lower CFB "Plan/Organize" T-score (<0) represents a better outcome. |
Baseline and Week 14 |
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| Other |
Change from baseline in the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) "Task Monitor" scale T-score at Week 14 (End of Study) |
The Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) is a 75-item self-rating scale that assesses overall functioning and 9 non-overlapping scales among 2 summary index scales. The "Task Monitor" scale is one of five Metacognition Index-related scales; it captures an individual's ability to assess performance for mistakes during or after finishing a task. The subject rates each item on a 3-point scale (1=Never, 2=Sometimes, or 3=Often) based on their experience in past month. The sum of 6 items yields the "Task Monitor" raw score (range: 6-18), which is converted to a T-score (normative population mean=50 and standard deviation=10; T-score = 65 is considered abnormally elevated). The post-baseline T-score is converted to a change from baseline (CFB) T-score. A lower CFB "Task Monitor" T-score (<0) represents a better outcome. |
Baseline and Week 14 |
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| Other |
Change from baseline in the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) "Organization of Materials" scale T-score at Week 14 (End of Study) |
The Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) is a 75-item self-rating scale that assesses overall functioning and 9 non-overlapping scales among 2 summary index scales. The "Organization of Materials" scale is one of five Metacognition Index-related scales; it captures one's ability to keep areas orderly and maintain materials. Subjects rate each item on a 3-point scale (1=Never, 2=Sometimes, 3=Often) based on their experience in past month. The sum of 8 items yields the "Organization of Materials" raw score (range: 8-24), which is converted to a T-score (normative population mean=50 and standard deviation=10; T-score = 65 is considered abnormally elevated). The post-baseline T-score is converted to a change from baseline (CFB) T-score. A lower CFB "Organization of Materials" T-score (<0) represents a better outcome. |
Baseline and Week 14 |
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| Other |
Change from baseline in the Work Productivity and Activity Impairment:Specific Health Problem (WPAI:SHP) Absenteeism percentage by visit |
The Work Productivity and Activity Impairment:Specific Health Problem (WPAI:SHP) Questionnaire is a self-assessment questionnaire that measures the impact of health problems on work productivity and regular activities based on specific health problem (e.g., ADHD). The WPAI:SHP consists of 6 questions that ask about the number of hours missed from work or regular activities due to the specific health problem. The WPAI:SHP yields 4 scores: absenteeism (percentage of time absent from work), presenteeism (percentage of time impaired/unproductive at work), total work productivity impairment (absenteeism plus presenteeism), and total activity impairment (percentage of time affected outside the workplace); range 0-100%; the higher percentage, the greater the impairment). Post-baseline percentages are converted to a change from baseline percentage. A lower change from baseline Absenteeism percentage (<0) represents a better outcome. |
Baseline and Week 4, 9, and 14 |
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| Other |
Change from baseline in the Work Productivity and Activity Impairment:Specific Health Problem (WPAI:SHP Presenteeism percentage by visit |
The Work Productivity and Activity Impairment:Specific Health Problem (WPAI:SHP) Questionnaire is a self-assessment questionnaire that measures the impact of health problems on work productivity and regular activities based on specific health problem (e.g., ADHD). The WPAI:SHP consists of 6 questions that ask about the number of hours missed from work or regular activities due to the specific health problem. The WPAI:SHP yields 4 scores: absenteeism (percentage of time absent from work), presenteeism (percentage of time impaired/unproductive at work), total work productivity impairment (absenteeism plus presenteeism), and total activity impairment (percentage of time affected outside the workplace); range 0-100%; the higher percentage, the greater the impairment). Post-baseline percentages are converted to a change from baseline percentage. A lower change from baseline Presenteeism percentage (<0) represents a better outcome. |
Baseline and Week 4, 9, and 14 |
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| Other |
Change from baseline in the Change from baseline in the Work Productivity and Activity Impairment:Specific Health Problem (WPAI:SHP) Work Productivity percentage by visit |
The Work Productivity and Activity Impairment:Specific Health Problem (WPAI:SHP) Questionnaire is a self-assessment questionnaire that measures the impact of health problems on work productivity and regular activities based on specific health problem (e.g., ADHD). The WPAI:SHP consists of 6 questions that ask about the number of hours missed from work or regular activities due to the specific health problem. The WPAI:SHP yields 4 scores: absenteeism (percentage of time absent from work), presenteeism (percentage of time impaired/unproductive at work), total work productivity impairment (absenteeism plus presenteeism), and total activity impairment (percentage of time affected outside the workplace); range 0-100%; the higher percentage, the greater the impairment). Post-baseline percentages are converted to a change from baseline percentage. A lower change from baseline Work Productivity percentage (<0) represents a better outcome. |
Baseline and Week 4, 9, and 14 |
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| Other |
Change from baseline in the Change from baseline in the Work Productivity and Activity Impairment:Specific Health Problem (WPAI:SHP) Regular Activity percentage by visit |
The Work Productivity and Activity Impairment:Specific Health Problem (WPAI:SHP) Questionnaire is a self-assessment questionnaire that measures the impact of health problems on work productivity and regular activities based on specific health problem (e.g., ADHD). The WPAI:SHP consists of 6 questions that ask about the number of hours missed from work or regular activities due to the specific health problem. The WPAI:SHP yields 4 scores: absenteeism (percentage of time absent from work), presenteeism (percentage of time impaired/unproductive at work), total work productivity impairment (absenteeism plus presenteeism), and total activity impairment (percentage of time affected outside the workplace); range 0-100%; the higher percentage, the greater the impairment). Post-baseline percentages are converted to a change from baseline percentage. A lower change from baseline Regular Activity percentage (<0) represents a better outcome. |
Baseline and Week 4, 9, and 14 |
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| Other |
Change from baseline in the Pittsburgh Sleep Quality Index (PSQI) Global score at Week 14 (End of Study) |
The Pittsburgh Sleep Quality Index (PSQI) is a validated and effective instrument used to measure the quality and patterns of sleep in adults. The PSQI is a self-rated, 19-item questionnaire out of which generate 7 component scores (or domains): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is scored on a 4-point scale based on an individual algorithm; range: 0 to 3, whereby 0=better and 3=worse). The sum of all 7 component scores yields the Global score (range:0 to 21); a global score >5 is associated with poor sleep quality. A post-baseline raw Global score is converted to a change from baseline Global score. A lower change from baseline Global score (<0) represents a better outcome. |
Baseline and Week 14 |
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| Other |
Change from baseline in the Pittsburgh Sleep Quality Index (PSQI) Sleep Quality Component score at Week 14 |
The Pittsburgh Sleep Quality Index (PSQI) is a validated and effective instrument used to measure the quality and patterns of sleep in adults. The PSQI is a self-rated, 19-item questionnaire out of which generate 7 component scores (or domains): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. The Sleep Quality (SQ) component is a single item (Q6). The subject rates their sleep quality very good (0), fairly good (1), Fairly bad (2), or Very bad (3). A post-baseline raw SQ component score is converted to a change from baseline SQ component score. A lower change from baseline SQ component score (<0) represents a better outcome. |
Baseline and Week 14 |
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| Other |
Change from baseline in the Pittsburgh Sleep Quality Index (PSQI) Sleep Latency Component score at Week 14 |
The Pittsburgh Sleep Quality Index (PSQI) is a validated and effective instrument used to measure the quality and patterns of sleep in adults. The PSQI is a self-rated 19-item questionnaire out of which generate 7 component scores (or domains): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. The Sleep Latency (SL) component is scored with an algorithm using 2 items (Q2 and Q5a); range: 0 to 3, whereby 0=better and 3=worse. A post-baseline raw SL component score is converted to a change from baseline SL component score. A lower change from baseline SL component score (<0) represents a better outcome. |
Baseline and Week 14 |
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| Other |
The change from baseline in the Pittsburgh Sleep Quality Index (PSQI) Sleep Duration Component score at Week 14 |
The Pittsburgh Sleep Quality Index (PSQI) is a validated and effective instrument used to measure the quality and patterns of sleep in adults. The PSQI is a self-rated 19-item questionnaire out of which generate 7 component scores (or domains): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. The Sleep Duration (SD) component is scored with an algorithm using a single item (Q4); range: 0 to 3, whereby 0=better and 3=worse. A post-baseline raw SD component score is converted to a change from baseline SD component score. A lower change from baseline SD component score (<0) represents a better outcome. |
Baseline and Week 14 |
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| Other |
The change from baseline in the Pittsburgh Sleep Quality Index (PSQI) Sleep Efficiency Component score at Week 14 |
The Pittsburgh Sleep Quality Index (PSQI) is a validated and effective instrument used to measure the quality and patterns of sleep in adults. The PSQI is a self-rated 19-item questionnaire out of which generate 7 component scores (or domains): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. The Sleep Efficiency (SE) component is scored with an algorithm using 3 items (Q1, Q2, Q4); range: 0 to 3, whereby 0=better and 3=worse. A post-baseline raw SE component score is converted to a change from baseline SE component score. A lower change from baseline SE component score (<0) represents a better outcome. |
Baseline and Week 14 |
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| Other |
The change from baseline in the Pittsburgh Sleep Quality Index (PSQI) Sleep Disturbance Component score at Week 14 |
The Pittsburgh Sleep Quality Index (PSQI) is a validated and effective instrument used to measure the quality and patterns of sleep in adults. The PSQI is a self-rated 19-item questionnaire out of which generate 7 component scores (or domains): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. The Sleep Disturbance (SDSTB) component is scored with an algorithm using 9 items (Q5b, Q5c, Q5d, Q5e, Q5f, Q5g, Q5h, Q5i, Q5j); range: 0 to 3, whereby 0=better and 3=worse. A post-baseline raw SDSTB component score is converted to a change from baseline SDSTB component score. A lower change from baseline SDSTB component score (<0) represents a better outcome. |
Baseline and Week 14 |
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| Other |
The change from baseline in the Pittsburgh Sleep Quality Index (PSQI) Sleep Medication Component score at Week 14 |
The Pittsburgh Sleep Quality Index (PSQI) is a validated and effective instrument used to measure the quality and patterns of sleep in adults. The PSQI is a self-rated 19-item questionnaire out of which generate 7 component scores (or domains): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. The Sleep Medication (SMED) component is scored with an algorithm using a single item (Q7); range: 0 to 3, whereby 0=better and 3=worse. A post-baseline raw SMED component score is converted to a change from baseline SMED component score. A lower change from baseline SMED component score (<0) represents a better outcome. |
Baseline and Week 14 |
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| Other |
The change from baseline in the Pittsburgh Sleep Quality Index (PSQI) Daytime Function Component score at Week 14 |
The Pittsburgh Sleep Quality Index (PSQI) is a validated and effective instrument used to measure the quality and patterns of sleep in adults. The PSQI is a self-rated 19-item questionnaire out of which generate 7 component scores (or domains): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. The Daytime Function (DF) component is scored with an algorithm using 2 items (Q8, Q9); range: 0 to 3, whereby 0=better and 3=worse. A post-baseline raw DF component score is converted to a change from baseline DF component score. A lower change from baseline DF component score (<0) represents a better outcome. |
Baseline and Week 14 |
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| Other |
The change from baseline in the Pittsburgh Sleep Quality Index (PSQI)-derived in-bed and out of bed decimal clock time at Week 14 |
The Pittsburgh Sleep Quality Index (PSQI) is a validated and effective instrument used to measure the quality and patterns of sleep in adults. The PSQI is a self-rated 19-item questionnaire out of which generate 7 component scores (or domains). Subjects report in-bed (Q1) and out of bed (Q3) clock times (average over past month). Clocktime (hh:mm) is converted to decimal clock time (h.m). In-bed and out of bed decimal clocktimes are converted to a change from baseline decimal. A lower change from baseline in-bed or out of bed decimal clocktime (<0.0) represents an earlier in-bed or out of bed time. |
Baseline and Week 14 |
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| Other |
The change from baseline in the Pittsburgh Sleep Quality Index (PSQI)-derived Duration of Time in Bed at Week 14 |
The Pittsburgh Sleep Quality Index (PSQI) is a validated and effective instrument used to measure the quality and patterns of sleep in adults. The PSQI is a self-rated 19-item questionnaire out of which generate 7 component scores (or domains). Subjects report In-bed (Q1) clock time and Out of Bed (Q3) clock time (average over past month). Clocktime (hh:mm) is converted to decimal clock time (h.m). Duration of time in bed (total minutes) = [Out of Bed decimal time (h.m) multiplied by 60] - [In-bed decimal (h.m) multiplied by 60]. Total minutes is converted to a change from baseline Total minutes. A lower change from baseline Total minutes (<0) represents a shorter duration of time in bed. |
Baseline and Week 14 |
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| Primary |
Change from baseline in the Adult ADHD Investigator Symptom Rating Scale (AISRS) Total score by visit. |
The Adult ADHD Investigator Symptom Rating Scale (AISRS) is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology in adults. The AISRS consists of 18 items that directly correspond to the 18 symptoms of ADHD per the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). The scale is subdivided into two subscales: Inattention (IA; 9 items) and Hyperactivity/Impulsivity (HI; 9 items). The clinician/investigator rates the subject on each item using a 4-point scale, where 0=none, 1=mild, 2=moderate, and 3=severe. The sum of the ratings of all 18 items yields the raw Total score (range: 0-54; the higher the Total score, the more severe the ADHD symptoms). Post-baseline raw Total scores are converted to a change from baseline Total score. A lower change from baseline Total Score (<0) represents a better outcome. |
Baseline and Week 4, 9, and 14 |
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| Secondary |
Change from baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Inattention and Hyperactivity/Impulsivity Subscale scores by visit. |
The Adult ADHD Investigator Symptom Rating Scale (AISRS) is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology in adults. The AISRS consists of 18 items that directly correspond to the 18 symptoms of ADHD per the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). The scale is subdivided into two subscales: Inattention (IA; 9 items) and Hyperactivity/Impulsivity (HI; 9 items). The clinician/investigator rates the subject on each item using a 4-point scale, where 0=none, 1=mild, 2=moderate, and 3=severe. The sum of the ratings of the respective 9 items yields the raw score for each subscale (range: 0-27; the higher the Subscale score, the more severe the symptoms). Post-baseline raw Subscale scores are converted to a change from baseline Subscale score. A lower change from baseline Subscale Score (<0) represents a better outcome. |
Baseline and Week 4, 9, and 14 |
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