- Reaction Time Domain of the Stroop Test (Cognitive and Executive Function) [ Time Frame: Baseline, 4 hour timepoint for extended days or last non-missing value for non-extended days on day 42 or early discontinuation (endpoint) ] [ Designated as safety issue: No ]
Stroop Test is a computerized measure of inhibition/disinhibition, executive function, reaction time, and information processing. The 1st part generates basic "reaction time" to colors. The 2nd part generates "complex reaction time score" to matching color names and font color. The 3rd part establishes a "Stroop reaction time" and an error score to unmatched color names/fonts. Reaction Time Domain Score = (Stroop Complex Reaction Time Correct + Stroop Reaction Time Correct)/2. Lower scores indicate better functioning (i.e. reaction time).
- Vigilance Domain (Complex Attention) of the Stroop Test/Shifting Attention Test (SAT)/Continuous Performance Test (CPT) (Cognitive and Executive Function) [ Time Frame: Baseline, endpoint (42 days or early discontinuation) ] [ Designated as safety issue: No ]
The Stroop Test is a computerized measure of inhibition/disinhibition, executive function, reaction time, and information processing. The Shifting Attention Test (SAT) a computerized measure of the ability to shift from one instruction set to another quickly and accurately. The Continuous Performance Test (CPT) is a computerized measure of vigilance or sustained attention/attention over time. Vigilance Domain (Complex Attention) Score = Stroop Commission Errors + SAT Errors + CPT Commission Errors + CPT Omission Errors. Lower scores indicate better functioning (i.e. sustained attention).
- Cognitive Flexibility Domain of the Stroop/SAT Tests (Cognitive and Executive Function) [ Time Frame: Baseline, 4 hour timepoint for extended days or last non-missing value for non-extended days on day 42 or early discontinuation (endpoint) ] [ Designated as safety issue: No ]
The Stroop Test is a computerized measure of inhibition/disinhibition, executive function, reaction time, and information processing. The SAT is a computerized measure of the ability to shift from one instruction set to another quickly and accurately. The scores generated by the SAT are: correct matches, errors, and response time. The testing score is a measure of cognitive flexibility. Cognitive Flexibility Domain Score = SAT Correct Responses - SAT Errors - Stroop Commission Errors. Higher scores indicate better accuracy.
- Processing Speed Domain of the Symbol Digit Modalities Test (SDTM) (Cognitive and Executive Function) [ Time Frame: Baseline, endpoint (42 days or early discontinuation) ] [ Designated as safety issue: No ]
The Symbol Digit Modalities Test (SDMT) is a computerized variant of the Wechsler Digit Symbol Substitution Test (DSST), but the position of symbols and digits is reversed. Scoring is the number of correct responses generated in 2 minutes. Processing Speed Domain = SDMT correct responses - SDMT errors. Higher scores indicate better functioning (i.e. information processing).
- Global Executive Composite (GEC) Score of the Brief Rating Inventory of Executive Function for Adults (BRIEF-A) [ Time Frame: Baseline, endpoint (42 days or early discontinuation) ] [ Designated as safety issue: No ]
The BRIEF-A is a self-reported measure (low=61, high=225, lower scores indicate higher executive functioning) capturing views of the subject's own functioning in the everyday environment. The BRIEF-A contains 75 scored items (1=never, 2=sometimes, 3=often) in 9 non-overlapping clinical scales (Inhibit, Shift, Emotional Control, Self-Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials). The Behavioral Regulation Index (BRI), Metacognition Index (MI), and GEC are then derived.
- Performance and Daily Functioning Scale of the Adult ADHD Impact Module (AIM-A) [ Time Frame: Baseline, endpoint (42 days or early discontinuation) ] [ Designated as safety issue: No ]
The AIM-A is a subject-reported measure (low=0, high=100, a higher score is more favorable) to assess the overall impact and role that ADHD may have in the conduct of tasks that are expected of adults. The AIM-A is comprised of four global quality of life items, five economic impact items, and five multi-item scales that describe important concepts. Items include: Living with ADHD; General Well-Being; Work, Home and School Performance and Daily Functioning; Relationships; and Communication; and Impact of Symptoms (emotional, degree of daily interference).
- Subject's Rating of Endicott Work Productivity Scale (EWPS) [ Time Frame: Baseline, endpoint (42 days or early discontinuation) ] [ Designated as safety issue: No ]
The EWPS provides a measure of the subject's report of their overall productivity (low=0, high=100, a higher score indicates worsening work productivity and efficiency). There are 25 items (questions 15-39) on the scale that describe types of behaviors/ subjective feelings that are highly likely to reduce work productivity/efficiency. These 25 items are rated on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, to 4=almost always) indicating how often the behavior, feeling or attitude has been manifested in the past week. The total score is the sum of the 25 items.
- Subject's Rating of Dyadic Satisfaction Subscale (DSS) [ Time Frame: Baseline, endpoint (42 days or early discontinuation) ] [ Designated as safety issue: No ]
The Dyadic Adjustment Scale (DAS) assesses the relationship satisfaction or adjustment of partners in committed couple relationships. The 32-question DAS includes 4 empirically validated subscales that measure: dyadic satisfaction, dyadic consensus, dyadic cohesion and affectional expression. The response format varies across the entire scale and includes 5-, 6-, and 7-point Likert-scale questions and two yes/no items. The 10-question subset of the DAS, the Dyadic Satisfaction Subscale, was used in this study (low=0, high=50, higher score means better relationship satisfaction).
- Subject's Rating of Satisfaction With Treatment Questionnaire - Overall, How Satisfied or Dissatisfied Are You With the Medication You Are Taking for ADHD? [ Time Frame: Endpoint (42 days or early discontinuation) ] [ Designated as safety issue: No ]
The satisfaction with treatment questionnaire (low=0, high=20, a lower score indicates lower satisfaction with treatment) requires subjects to answer 4 questions related to how much their ADHD symptoms have changed since starting the medication, how much benefit they received from the medication, the extent, if any, the advantages outweighed the disadvantages, and overall satisfaction with the medication. The responses for this question vary with range of satisfaction (e.g. extremely satisfied, very satisfied, satisfied, neutral, dissatisfied, very dissatisfied, or extremely dissatisfied).
- Responder Rate Using AISRS [ Time Frame: Endpoint (42 days or early discontinuation) ] [ Designated as safety issue: No ]
AISRS responder rate is defined as the percentage of subjects with AISRS < 18 at endpoint.
- Clinical Global Impression - Severity of Illness Subscale (CGI-S) [ Time Frame: Baseline, endpoint (42 days or early discontinuation) ] [ Designated as safety issue: No ]
The Clinical Global Impression - Severity of Illness (CGI-S) is a clinician-rated subscale (low=0, high=7, higher score indicates increasing illness). The clinician rates the severity of the ADHD symptoms in relation to the clinician's total experience with ADHD subjects using a 7-point scale (1=normal, not at all ill, 2= borderline ill, 3= mildly ill, 4=moderately ill, 5= markedly ill, 6= severely ill, 7= among the most extremely ill subjects) in response to the question "Considering your total clinical experience with this particular population, how ill is the subject at this time?".
- Significant Other's (a Spouse, Significant Other or Other Adult in the Household, Described in This Study as the Designated Observer) Rating of Adult ADHD Rating Scale IV [ Time Frame: Baseline, endpoint (42 days or early discontinuation) ] [ Designated as safety issue: No ]
The ADHD Rating Scale-IV (Significant Other) is an 18-item list of core ADHD symptoms corresponding to the DSM-IV diagnostic symptoms. Each item is rated on a four point Likert type scale (0 = never or rarely, 1 = sometimes, 2 = often, and 3 = very often). The subject's designated observer will complete this scale, with baseline assessment based on the subject's usual functioning when not on medication. The total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).
- Designated Observer's (DO) Global Executive Composite (GEC) Score of the Brief Rating Inventory of Executive Function for Adults (BRIEF-A) [ Time Frame: Baseline, endpoint (42 days or early discontinuation) ] [ Designated as safety issue: No ]
The BRIEF-A, as completed by the DO, is a measure (low=61, high=225, lower scores indicate higher executive functioning) capturing views of an adult informant familiar with the subject's functioning. The BRIEF-A contains 75 scored items (1=never, 2=sometimes, 3=often) in nine non-overlapping clinical scales (Inhibit, Shift, Emotional Control, Self-Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials). The Behavioral Regulation Index (BRI), Metacognition Index (MI), and Global Executive Composite (GEC) are then derived.
- Designated Observer's (DO) Rating of Dyadic Satisfaction Subscale [ Time Frame: Baseline, endpoint (42 days or early discontinuation) ] [ Designated as safety issue: No ]
The Dyadic Adjustment Scale (DAS) completed by DOs who were spouses or significant others assesses the relationship satisfaction or adjustment of partners in committed couple relationships. The 32-question DAS includes 4 empirically validated subscales that measure: dyadic satisfaction, dyadic consensus, dyadic cohesion and affectional expression. Possible responses include 5-, 6-, and 7-point Likert-scale questions and two yes/no items. The 10-question DAS subset, the Dyadic Satisfaction Subscale, was used in this study (low=0, high=50, higher score means better relationship satisfaction).
- Designated Observer's (DO) Rating of Satisfaction With Treatment Questionnaire - Overall, How Satisfied or Dissatisfied Are You With the Medication for ADHD Your Partner is Taking? [ Time Frame: Endpoint (42 days or early discontinuation) ] [ Designated as safety issue: No ]
The satisfaction with treatment questionnaire (low=0, high=20, a lower score indicates lower satisfaction with treatment) requires the subject's DO to answer 4 questions related to how much the subject's ADHD symptoms have changed since starting the medication, how much benefit was received from the medication, the extent, if any, the advantages outweighed the disadvantages, and overall satisfaction with the medication. Responses vary from extremely satisfied, very satisfied, satisfied, neutral, mildly dissatisfied, dissatisfied, very dissatisfied, or extremely dissatisfied.
- Adult ADHD Self-Report Scale (ASRS) Over Time [ Time Frame: Baseline, endpoint (42 days or early discontinuation) ] [ Designated as safety issue: No ]
The Adult ADHD Self-Report Scale (ASRS) assesses 18 core ADHD symptoms corresponding to the DSM-IV diagnostic symptoms for adult subjects based on the subject's own rating for each of the symptoms using a four point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).
- Pittsburgh Sleep Quality Index (PSQI) Total Score [ Time Frame: Baseline, endpoint (42 days or early discontinuation) ] [ Designated as safety issue: No ]
The PSQI discriminates between good and poor sleepers. The self-administered scale contains 15 multiple-choice items concerning frequency of sleep disturbances and subjective sleep quality and 4 write-in items that inquire about typical bedtime, wake-up time, sleep latency, and sleep duration over the past month. The PSQI generates 7 scores corresponding to the different sleep domains. Each component score ranges from 0 to 3. Total sleep index is calculated by adding up the 7 component scores (low=0, high=21, the lower the score, the better in sleep quality).
- Epworth Sleepiness Scale (ESS) [ Time Frame: Baseline, endpoint (42 days or early discontinuation) ] [ Designated as safety issue: No ]
The Epworth Sleepiness Scale (ESS) is an 8-item self-rated questionnaire designed to assess the overall level of daytime sleepiness. Each item describes normal daily situations (i.e., watching TV, lying down in the afternoon, sitting inactive in a public place) and subjects rate the likelihood of dozing off or falling asleep in each situation. Responses use a 4-point rating scale (0=would never doze, 1=slight chance of dozing, 2=moderate chance of dozing, 3=high chance of dozing). Item scores are summed to produce a total score (range of 0-24) with lower score suggesting more alertness.
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