Software Treatment for Actively Reducing Severity of ADHD in Adults (STARS ADHD Adult)

Test of Variables of Attention (TOVA)-Attention Comparison Score (ACS) of sustained and selective attention. Measures at Day 1 and Exit/Post-Treatment Visit Day 42

TOVA ACS is a comparison of a subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated. ACS is calculated using the following formula: TOVA ACS = Response Time Z score (Half 1) + d' Z score (Half 2) + Variability Z score (Total) + 1.80 where Response Time is the average time it takes to respond correctly to a target, d' score is a response discriminability score reflecting the ratio of hits to "false alarms", and Variability is a measure of consistency of speed of responding based on the standard deviation of the mean correct response times. A score of less than 0 indicates that the subject had similar performance to a normative ADHD population. A lower score indicates a more severe ADHD profile.

Change in the Attention Deficit Hyperactive Disorder (ADHD) Rating Scale-IV inattention sub-scale and total scale scores. Measures taken at Baseline Visit (Day 1) and Exit/Post-Treatment Visit (Day 42).

ADHD Rating Scale-IV is a clinician-administered questionnaire. The questionnaire is an 18-item scale that provides a rating of the severity of symptoms for Inattention and Hyperactivity-Impulsivity. The total score is obtained by adding the Inattention and Hyperactivity-Impulsivity subscale raw scores. Each item is rated on a 4-point scale; None (0), mild (1), moderate (2), severe (3). A higher score indicates more severe ADHD symptoms and behaviors.

Change in the Adult ADHD Quality of Life Questionnaire (AAQoL) total score. Measures taken at Baseline Visit (Day 1) and Exit/Post-Treatment Visit (Day 42).

AAQoL has 29 items to assess health-related quality of life during the past two weeks among adults with ADHD. Each item is rated by patients on a five-point Likert scale, Not at all/ Never (1) to Extremely/Very Often (5). The AAQoL has a total score and four subscale scores: Life Productivity, Psychological Health, Life Outlook, Relationships

Total and subscale scores are computed by (1) reversing scores for all items except the seven items in the Life Outlook subscale; (2) transforming all item scores to a 0-100 point scale (1=0; 2=25; 3=50; 4=75; 5=100); and (3) summing item scores and dividing by the item count to generate subscale and total scores. The scoring algorithm indicates that the total score can be computed with up to three missing items, and each subscale score can be computed with up to one missing item.

Change in the Adult ADHD Quality of Life Questionnaire (AAQoL) subscale score for Life Productivity. Measures taken at Baseline Visit (Day 1) and Exit/Post-Treatment Visit (Day 42).

AAQoL has 29 items to assess health-related quality of life during the past two weeks among adults with ADHD. Each item is rated by patients on a five-point Likert scale ranging from Not at all/ Never (1) to Extremely/Very Often (5). The AAQoL has a total score and four subscale scores.

The subscale, Life Productivity is 11 items, including getting things done on time, completing projects or tasks, remembering important things, and balancing multiple projects.

Subscale scores are computed by (1) reversing scores for all items except the seven items in the Life Outlook subscale; (2) transforming all item scores to a 0-100 point scale (1=0; 2=25; 3=50; 4=75; 5=100); and (3) summing item scores and dividing by the item count to generate subscale scores.

Change in the Conners' Adult ADHD Rating Scales-Self Report: Short Version (CAASRS:S) score. Measures taken at Baseline Visit (Day 1) and Exit/Post-Treatment Visit (Day 42).

CAASRS:S is a Likert scale, 26-question questionnaire used to rate a patient's current functioning ability. The scores are computed by 0 = Not at all, never; 1 = Just a little, once in a while; 2 = Pretty much, often; and 3 = Very much, very frequently.

A proportion of the responders with 30% reduction in the total (ADHD) Rating Scale-IV scores. Measures taken at Baseline Visit (Day 1) and Exit/Post-Treatment Visit (Day 42).

ADHD Rating Scale-IV is a clinician-administered questionnaire. The questionnaire is an 18-item scale that provides a rating of the severity of symptoms for Inattention and Hyperactivity-Impulsivity. The total score is obtained by adding the Inattention and Hyperactivity-Impulsivity subscale raw scores. Each item is rated on a 4-point scale; None (0), mild (1), moderate (2), severe (3). A higher score indicates more severe ADHD symptoms and behaviors.

A proportion of the responders with an 8-point change in the Adult ADHD Quality of Life Questionnaire (AAQoL) score taken at (Day 1) and Exit/Post-Treatment Visit (Day 42).

AAQoL has 29 items to assess health-related quality of life during the past two weeks among adults with ADHD. Each item is rated by patients on a five-point Likert scale ranging from Not at all/ Never (1) to Extremely/Very Often (5). The AAQoL yields a total score (based on all 29 items) and four subscale scores.

Subscale scores are computed by (1) reversing scores for all items except the seven items in the Life Outlook subscale; (2) transforming all item scores to a 0-100 point scale (1=0; 2=25; 3=50; 4=75; 5=100); and (3) summing item scores and dividing by the item count to generate subscale and total scores. The scoring algorithm indicates that the total score can be computed with up to three missing items, and each subscale score can be computed with up to one missing item.

To evaluate changes in the following additional Test of Variables of Attention (TOVA) metrics other than Attention Comparison Score (ACS) - Ex-Gaussian Tau.

TOVA is a comparison of a subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated.

TOVA metric evaluated for change is:

Ex-Gaussian Tau: The exponential decay (or "right hand tail") of the correct response times, modeled using the Ex-Gaussian distribution. Total refers to entire test (both H1 and H2). H1 refers to the first half of the test where target stimulus is infrequent (1 target to 3.5 non-targets), and H2 represents the second half where target stimulus is frequent (3.5 targets to 1 non-target).

Measures at Day 1 and Exit/Post-Treatment Visit Day 42.

To evaluate changes in the following additional Test of Variables of Attention (TOVA) metrics other than Attention Comparison Score (ACS) - Commission Errors Standard.

TOVA is a comparison of a subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated.

TOVA metric evaluated for change is:

Commission Errors Standard Score H2: Commission errors are the number of times the patient clicked the microswitch at the incorrect time. H2 represents the second half where target stimulus is frequent (3.5 targets to 1 non-target).

Measures at Day 1 and Exit/Post-Treatment Visit Day 42.

To evaluate changes in the following additional Test of Variables of Attention (TOVA) metrics other than Attention Comparison Score (ACS) - Response Time Variability Standard Score Total.

TOVA is a comparison of a subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated.

TOVA metric evaluated for change is:

Response Time Variability Standard Score Total: The standard score for the first standard deviation of the correct response times. Total refers to entire test (both H1 and H2). H1 refers to the first half of the test where target stimulus is infrequent (1 target to 3.5 non-targets), and H2 represents the second half where target stimulus is frequent (3.5 targets to 1 non-target).

Measures at Day 1 and Exit/Post-Treatment Visit Day 42.

To evaluate changes in the following additional Test of Variables of Attention (TOVA) metrics other than Attention Comparison Score (ACS) - Response Time Mean Standard Score H1.

TOVA is a comparison of a subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated.

TOVA metric evaluated for change is:

Response Time Mean Standard Score H1:The standard score for the mean response time of the correct responses. H1 refers to the first half of the test where target stimulus is infrequent (1 target to 3.5 non-targets).

Measures at Day 1 and Exit/Post-Treatment Visit Day 42.

To evaluate changes in the following additional Test of Variables of Attention (TOVA) metrics other than Attention Comparison Score (ACS) - D-Prime Standard Score H2.

TOVA is a comparison of a subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated.

TOVA metric evaluated for change is:

D-Prime Standard Score H2: D-Prime score is a response discriminability score reflecting the ratio of hits to false alarms. The measure is derived from Signal Detection Theory and has been shown to help distinguish non-impaired individuals from those diagnosed with attention disorders. The score reflects the accuracy of target (signal) and nontarget (noise) discrimination and can be interpreted as a measure of perceptual sensitivity. H2 represents the second half where target stimulus is frequent (3.5 targets to 1 non-target).

Measures at Day 1 and Exit/Post-Treatment Visit Day 42.

To evaluate changes in the following additional Test of Variables of Attention (TOVA) metrics other than Attention Comparison Score (ACS) - Omission Errors Standard Score H2.

TOVA is a comparison of a subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated.

TOVA metric evaluated for change is:

Omission Errors Standard Score H2: Omission Errors are the number of times the patient failed to click the microswitch when the target was presented. H2 represents the second half where target stimulus is frequent (3.5 targets to 1 non-target).

Measures at Day 1 and Exit/Post-Treatment Visit Day 42.