Study of the Duration and Efficacy of MYDAYIS on Adult ADHD Symptoms and Executive Function Throughout the Day Into the Early Evening

Attention Deficit-Hyperactivity Clinical Trial

— MYDAYIS  

Official title:

Study of the Duration and Efficacy of MYDAYIS on Adult ADHD Symptoms and Executive Function Throughout the Day Into the Early Evening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03945175
• Other study ID #: 19-00046
• Status: Completed
• Phase: Phase 3
• Start date: July 15, 2020
• Est. completion date: May 11, 2022

Study information

• Verified date: March 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Attention-deficit/hyperactivity disorder (ADHD) is a neuropsychiatric disorder characterized by problems with sustaining attention, organization, planning, procrastination, daydreaming, restlessness, impulsivity and hyperactivity.This is an outpatient study for subjects between the ages of 18-60, who have an Attention deficit hyperactivity disorder (ADHD) diagnosis meeting all inclusion criteria and not meeting any of the exclusion criteria.

Description:

One purpose of this trial is to extend the evidence basis for Mydayis in adult ADHD to include efficacy with a clinical ADHD symptom measure validated for DSM-5 adult ADHD. Another purpose of this trial is to re-examine the clinical efficacy of Mydayis later in the day on ADHD symptoms; the data on ADHD symptoms via the TASS 1 (Spencer et al. 2008) is a decade old and has not been examined in subsequent trials.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 11, 2022
• Est. primary completion date: May 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Male or female between the ages of 18-60 of all races and ethnicity.

• Meets DSM V-TR criteria for a primary diagnosis of ADHD (including predominantly inattentive presentation, or combined presentation) as diagnosed via the Adult ADHD Clinician Diagnostic Scale version 1.2 (ACDS v1.2)

Exclusion Criteria:

• Meets DSM V-TR criteria for a primary diagnosis of hyperactive-impulsive type ADHD as diagnosed via the ACDS v1.2.

• Any other current psychiatric disorder, determined via the M.I.N.I, which requires pharmacotherapy treatment.

• Current suicidal ideation or history of suicide attempts, based on the Columbia- Suicide Severity Rating Scale(C-SSRS)

• Lifetime history of bipolar disorder or any psychotic disorder as per the M.I.N.I

• Pregnant, breastfeeding or women planning to become pregnant.

• Positive urine drug toxicology are excluded.

• Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit-Hyperactivity
• Hyperkinesis

Intervention

Drug:
• MYDAYIS
MYDAYIS treatment will be given at a minimum dose of 12.5mg/day and will increase in increments of 12.5mg, up to 37.5mg, based upon clinical response and tolerability.
• Placebo
During the two-week, placebo lead-in, all patients will receive 12.5mg of placebo at Visit 1 and Visit 2.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adult ADHD Investigator Symptom Rating Scale (AISRS) Score at End of Placebo Lead-In	18-item questionnaire measuring aspects of ADHD in adults. Participants rank items on a 4-point Likert scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of ADHD.	Week 2 (End of Placebo Lead-In)
Primary	Adult ADHD Investigator Symptom Rating Scale (AISRS) Score at End of Mydayis Treatment	18-item questionnaire measuring aspects of ADHD in adults. Participants rank items on a 4-point Likert scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of ADHD.	Week 6 (End of Mydayis Treatment)
Secondary	AISRS: Overall Inattentive (IA) Symptom Subscale Score at End of Placebo Lead-In	The IA symptom subscale comprises 9 items of the AISRS measuring inattentive symptoms of ADHD. Items are ranked on a 4-point Likert scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The total IA subscale score ranges from 0 to 27; higher scores indicate more severe IA symptoms.	Week 2 (End of Placebo Lead-In)
Secondary	AISRS: Overall Inattentive (IA) Symptom Subscale Score at End of Mydayis Treatment	The IA symptom subscale comprises 9 items of the AISRS measuring inattentive symptoms of ADHD. Items are ranked on a 4-point Likert scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The total IA subscale score ranges from 0 to 27; higher scores indicate more severe IA symptoms.	Week 6 (End of Mydayis Treatment)
Secondary	AISRS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Placebo Lead-In	The HI symptom subscale comprises 9 items of the AISRS measuring hyperactive-impulsive symptoms of ADHD. Items are ranked on a 4-point Likert scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The total IA subscale score ranges from 0 to 27; higher scores indicate more severe HI symptoms.	Week 2 (End of Placebo Lead-In)
Secondary	AISRS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Mydayis Treatment	The HI symptom subscale comprises 9 items of the AISRS measuring hyperactive-impulsive symptoms of ADHD. Items are ranked on a 4-point Likert scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The total IA subscale score ranges from 0 to 27; higher scores indicate more severe HI symptoms.	Week 6 (End of Mydayis Treatment)
Secondary	Clinical Global Impression-Severity (CGI-S) Scale Score at End of Placebo Lead-In	7-item questionnaire requiring a clinician to rate the severity of a patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. The ratings range from 1-7, where: 1 = Normal, not at all ill; 2 = Borderline mentally ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; and 7 = Among the most extremely ill patients.	Week 2 (End of Placebo Lead-In)
Secondary	Clinical Global Impression-Severity (CGI-S) Scale Score at End of Mydayis Treatment	7-item questionnaire requiring a clinician to rate the severity of a patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. The ratings range from 1-7, where: 1 = Normal, not at all ill; 2 = Borderline mentally ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; and 7 = Among the most extremely ill patients.	Week 6 (End of Mydayis Treatment)
Secondary	14-Hour Post-Dose Time-Sensitive Adult ADHD Symptom Scale (TASS) Score at End of Placebo Lead-In	18-item assessment of the severity of ADHD symptoms administered 14 hours after morning dosing. Items are ranked on a 4-point Likert scale: 0 (not at all), 1 (mild), 2 (moderate), 3 (severe). The total score is the sum of all the items on the scale and ranges from 0 to 54. A higher total score indicates more severe ADHD.	Week 2 (End of Placebo Lead-In)
Secondary	14-Hour Post-Dose Time-Sensitive Adult ADHD Symptom Scale (TASS) Score at End of Mydayis Treatment	18-item assessment of the severity of ADHD symptoms administered 14 hours after morning dosing. Items are ranked on a 4-point Likert scale: 0 (not at all), 1 (mild), 2 (moderate), 3 (severe). The total score is the sum of all the items on the scale and ranges from 0 to 54. A higher total score indicates more severe ADHD.	Week 6 (End of Mydayis Treatment)
Secondary	14-hour Post-Dose TASS: Inattentive (IA) Symptom Subscale Score at End of Placebo Lead-In	The IA symptom subscale comprises 9 items of the TASS measuring inattentive symptoms of ADHD. Items are ranked on a 4-point Likert scale: 0 (not at all), 1 (mild), 2 (moderate), 3 (severe). The total IA subscale score ranges from 0 to 27; higher scores indicate more severe IA symptoms. Administered 14 hours after morning dosing.	Week 2 (End of Placebo Lead-In)
Secondary	14-hour Post-Dose TASS: Inattentive (IA) Symptom Subscale Score at End of Mydayis Treatment	The IA symptom subscale comprises 9 items of the TASS measuring inattentive symptoms of ADHD. Items are ranked on a 4-point Likert scale: 0 (not at all), 1 (mild), 2 (moderate), 3 (severe). The total IA subscale score ranges from 0 to 27; higher scores indicate more severe IA symptoms. Administered 14 hours after morning dosing.	Week 6 (End of Mydayis Treatment)
Secondary	14-hour Post-Dose TASS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Placebo Lead-In	The HI symptom subscale comprises 9 items of the TASS measuring inattentive symptoms of ADHD. Items are ranked on a 4-point Likert scale: 0 (not at all), 1 (mild), 2 (moderate), 3 (severe). The total IA subscale score ranges from 0 to 27; higher scores indicate more severe HI symptoms. Administered 14 hours after morning dosing.	Week 2 (End of Placebo Lead-In)
Secondary	14-hour Post-Dose TASS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Mydayis Treatment	The HI symptom subscale comprises 9 items of the TASS measuring inattentive symptoms of ADHD. Items are ranked on a 4-point Likert scale: 0 (not at all), 1 (mild), 2 (moderate), 3 (severe). The total IA subscale score ranges from 0 to 27; higher scores indicate more severe HI symptoms. Administered 14 hours after morning dosing.	Week 6 (End of Mydayis Treatment)
Secondary	Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Score at Week 3	75-item questionnaire measuring an adult's cognitive, emotional, and behavioral functions within the past month. Items ranked on 3-point Likert scale (1 = Never, 2 = Sometimes, 3 = Often). Raw scores are calculated and used to generate T-scores for 8 scales (Inhibit; Shift; Emotional Control; Initiate; Working Memory; Plan/Organize; Task Monitor; and Organization of Materials), 2 summary index scales (Behavioral Regulation Index and Metacognition Index), and 1 scale reflecting overall functioning (Global Executive Composite). T-scores range from 30 to 100, with scores =65 indicating clinical impairment.	Week 3
Secondary	Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Score at Week 7	75-item questionnaire measuring an adult's cognitive, emotional, and behavioral functions within the past month. Items ranked on 3-point Likert scale (1 = Never, 2 = Sometimes, 3 = Often). Raw scores are calculated and used to generate T-scores for 8 scales (Inhibit; Shift; Emotional Control; Initiate; Working Memory; Plan/Organize; Task Monitor; and Organization of Materials), 2 summary index scales (Behavioral Regulation Index and Metacognition Index), and 1 scale reflecting overall functioning (Global Executive Composite). T-scores range from 30 to 100, with scores =65 indicating clinical impairment.	Week 7
Secondary	WebNeuro Neurocognitive Assessment - Working Memory Capacity - Recall Span Score at Baseline	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the working memory capacity - recall span domain, participants complete forward digit span task and are assessed based on the maximum length of a sequence of visually presented digits able to be entered on a keypad in correct order. The total score is the maximum length of the sequence of digits.	Baseline
Secondary	WebNeuro Neurocognitive Assessment - Working Memory Capacity - Recall Span Score at Week 7	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the working memory capacity - recall span domain, participants complete forward digit span task and are assessed based on the maximum length of a sequence of visually presented digits able to be entered on a keypad in correct order. The total score is the maximum length of the sequence of digits.	Week 7
Secondary	WebNeuro Neurocognitive Assessment - Working Memory Capacity - Working Memory Accuracy at Baseline	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the working memory capacity - working memory accuracy domain, participants complete a digit span task. Participants are assessed based on the total number of correct trials in the forward digit span task where each incremental span length has two trials- at least one of which needs to be recalled correctly to progress.	Baseline
Secondary	WebNeuro Neurocognitive Assessment - Working Memory Capacity - Working Memory Accuracy at Week 7	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the working memory capacity - working memory accuracy domain, participants complete a digit span task. Participants are assessed based on the total number of correct trials in the forward digit span task where each incremental span length has two trials- at least one of which needs to be recalled correctly to progress.	Week 7
Secondary	WebNeuro Neurocognitive Assessment - Attention and Concentration - Reaction Time at Baseline	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the attention and concentration - reaction time domain, participants complete a continuous performance test. Participants are assessed based on their reaction time to space-bar presses, averaged across all correctly identified target stimuli (same letter presented twice in a row).	Baseline
Secondary	WebNeuro Neurocognitive Assessment - Attention and Concentration - Reaction Time at Week 7	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the attention and concentration - reaction time domain, participants complete a continuous performance test. Participants are assessed based on their reaction time to space-bar presses, averaged across all correctly identified target stimuli (same letter presented twice in a row).	Week 7
Secondary	WebNeuro Neurocognitive Assessment - Attention and Concentration - False Alarms at Baseline	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the attention and concentration - false alarms domain, participants complete a continuous performance test. Participants are assessed based on the number of times the space-bar was pressed at any time not in response to a "target" stimulus.	Baseline
Secondary	WebNeuro Neurocognitive Assessment - Attention and Concentration - False Alarms at Week 7	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the attention and concentration - false alarms domain, participants complete a continuous performance test. Participants are assessed based on the number of times the space-bar was pressed at any time not in response to a "target" stimulus.	Week 7
Secondary	WebNeuro Neurocognitive Assessment - Attention and Concentration - False Misses at Baseline	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the attention and concentration - false misses domain, participants complete a continuous performance test. Participants are assessed based on the number of times when the space-bar was NOT pressed following a target stimulus.	Baseline
Secondary	WebNeuro Neurocognitive Assessment - Attention and Concentration - False Misses at Week 7	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the attention and concentration - false misses domain, participants complete a continuous performance test. Participants are assessed based on the number of times when the space-bar was NOT pressed following a target stimulus.	Week 7
Secondary	WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Completion Time at Baseline	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - completion time domain, participants complete a switching of attention task. Participants are assessed based on the total amount of time taken to complete the whole sequence of digits and letters.	Baseline
Secondary	WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Completion Time at Week 7	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - completion time domain, participants complete a switching of attention task. Participants are assessed based on the total amount of time taken to complete the whole sequence of digits and letters.	Week 7
Secondary	WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Average Connection Time at Baseline	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - average connection time domain, participants complete a switching of attention task. Participants are assessed based on the average time between correct responses.	Baseline
Secondary	WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Average Connection Time at Week 7	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - average connection time domain, participants complete a switching of attention task. Participants are assessed based on the average time between correct responses.	Week 7
Secondary	WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors at Baseline	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - errors domain, participants complete a switching of attention task. Participants are assessed based on the number of times an incorrect digit or letter in the sequence was pressed.	Baseline
Secondary	WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors at Week 7	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - errors domain, participants complete a switching of attention task. Participants are assessed based on the number of times an incorrect digit or letter in the sequence was pressed.	Week 7
Secondary	WebNeuro Neurocognitive Assessment - Response Speed - Number of Taps at Baseline	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the response speed - number of taps domain, participants complete a motor tapping task. Participants are assessed based on the number of times they were able to tap the spacebar in 30 seconds with their dominant hand.	Baseline
Secondary	WebNeuro Neurocognitive Assessment - Response Speed - Number of Taps at Week 7	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the response speed - number of taps domain, participants complete a motor tapping task. Participants are assessed based on the number of times they were able to tap the spacebar in 30 seconds with their dominant hand.	Week 7
Secondary	WebNeuro Neurocognitive Assessment - Response Speed - Tapping Variability at Baseline	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the response speed - tapping variability domain, participants complete a motor tapping task. Participants are assessed based on the standard deviation of the time interval between taps on the space-bar for the dominant hand.	Baseline
Secondary	WebNeuro Neurocognitive Assessment - Response Speed - Tapping Variability at Week 7	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the response speed - tapping variability domain, participants complete a motor tapping task. Participants are assessed based on the standard deviation of the time interval between taps on the space-bar for the dominant hand.	Week 7
Secondary	WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time at Baseline	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - reaction time domain, participants complete a choice reaction time task. Participants are assessed based on the average time taken to press the left or right arrow to correspond with which circle (left or right) is highlighted in each trial.	Baseline
Secondary	WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time at Week 7	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - reaction time domain, participants complete a choice reaction time task. Participants are assessed based on the average time taken to press the left or right arrow to correspond with which circle (left or right) is highlighted in each trial.	Week 7
Secondary	WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Score (Words) at Baseline	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - score (words) domain, participants complete a verbal interference (word) task. Participants are assessed based on the number of stimuli for which the name of the color-word was correctly selected (ignoring the font-color of the word) in the time limit of 30 seconds (i.e., a higher score reflects greater speed).	Baseline
Secondary	WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Score (Words) at Week 7	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - score (words) domain, participants complete a verbal interference (word) task. Participants are assessed based on the number of stimuli for which the name of the color-word was correctly selected (ignoring the font-color of the word) in the time limit of 30 seconds (i.e., a higher score reflects greater speed).	Week 7
Secondary	WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors (Words) at Baseline	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - errors (words) domain, participants complete a verbal interference (word) task. Participants are assessed based on the number of stimuli for which the name of the color-word was incorrectly selected (ignoring the font-color of the word) in the time limit of 30 seconds (i.e., a higher score reflects more errors).	Baseline
Secondary	WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors (Words) at Week 7	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - errors (words) domain, participants complete a verbal interference (word) task. Participants are assessed based on the number of stimuli for which the name of the color-word was incorrectly selected (ignoring the font-color of the word) in the time limit of 30 seconds (i.e., a higher score reflects more errors).	Week 7
Secondary	WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time (Words) at Baseline	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - reaction time (words) domain, participants complete a verbal interference (word) task. Participants are assessed based on the average reaction time for the stimuli for which the name of the color-word was correctly selected (ignoring the font-color of the word).	Baseline
Secondary	WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time (Words) at Week 7	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - reaction time (words) domain, participants complete a verbal interference (word) task. Participants are assessed based on the average reaction time for the stimuli for which the name of the color-word was correctly selected (ignoring the font-color of the word).	Week 7
Secondary	WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Score (Colors) at Baseline	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - score (colors) domain, participants complete a verbal interference (color) task. Participants are assessed based on the number of stimuli for which the font-color of the color-word was correctly selected (ignoring the name of the word) in the time limit of 30 seconds (i.e., a higher score reflects greater speed).	Baseline
Secondary	WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Score (Colors) at Week 7	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - score (colors) domain, participants complete a verbal interference (color) task. Participants are assessed based on the number of stimuli for which the font-color of the color-word was correctly selected (ignoring the name of the word) in the time limit of 30 seconds (i.e., a higher score reflects greater speed).	Week 7
Secondary	WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors (Colors) at Baseline	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - errors (colors) domain, participants complete a verbal interference (color) task. Participants are assessed based on the number of stimuli for which the font-color of the color-word was incorrectly selected (ignoring the name of the word) in the time limit of 30 seconds (i.e., a higher score reflects more errors).	Baseline
Secondary	WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors (Colors) at Week 7	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - errors (colors) domain, participants complete a verbal interference (color) task. Participants are assessed based on the number of stimuli for which the font-color of the color-word was incorrectly selected (ignoring the name of the word) in the time limit of 30 seconds (i.e., a higher score reflects more errors).	Week 7
Secondary	WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time (Colors) at Baseline	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - reaction time (colors) domain, participants complete a verbal interference (color) task. Participants are assessed based on the average reaction time for the stimuli for which the font-color of the color-word was correctly selected (ignoring the name of the word).	Baseline
Secondary	WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time (Colors) at Week 7	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - reaction time (colors) domain, participants complete a verbal interference (color) task. Participants are assessed based on the average reaction time for the stimuli for which the font-color of the color-word was correctly selected (ignoring the name of the word).	Week 7
Secondary	WebNeuro Neurocognitive Assessment - Executive Function - Trials Completed at Baseline	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the executive function - trials completed domain, participants complete a maze task. Participants are assessed based on the number of trials taken to successfully complete the maze without error twice consecutively.	Baseline
Secondary	WebNeuro Neurocognitive Assessment - Executive Function - Trials Completed at Week 7	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the executive function - trials completed domain, participants complete a maze task. Participants are assessed based on the number of trials taken to successfully complete the maze without error twice consecutively.	Week 7
Secondary	WebNeuro Neurocognitive Assessment - Executive Function - Completion Time at Baseline	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the executive function - completion time domain, participants complete a maze task. Participants are assessed based on the time taken to successfully complete the maze without error twice consecutively.	Baseline
Secondary	WebNeuro Neurocognitive Assessment - Executive Function - Completion Time at Week 7	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the executive function - completion time domain, participants complete a maze task. Participants are assessed based on the time taken to successfully complete the maze without error twice consecutively.	Week 7
Secondary	WebNeuro Neurocognitive Assessment - Executive Function - Path Learning Time at Baseline	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the executive function - path learning time domain, participants complete a maze task. Participants are assessed based on the time taken to the end of the final trial with at least one error- just before successfully completing the maze without error twice consecutively.	Baseline
Secondary	WebNeuro Neurocognitive Assessment - Executive Function - Path Learning Time at Week 7	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the executive function - path learning time domain, participants complete a maze task. Participants are assessed based on the time taken to the end of the final trial with at least one error- just before successfully completing the maze without error twice consecutively.	Week 7
Secondary	WebNeuro Neurocognitive Assessment - Executive Function - Total Errors at Baseline	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the executive function - total errors domain, participants complete a maze task. Participants are assessed based on the cumulative number of all types of errors made across all trials taken to complete the maze without error twice consecutively.	Baseline
Secondary	WebNeuro Neurocognitive Assessment - Executive Function - Total Errors at Week 7	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the executive function - total errors domain, participants complete a maze task. Participants are assessed based on the cumulative number of all types of errors made across all trials taken to complete the maze without error twice consecutively.	Week 7
Secondary	WebNeuro Neurocognitive Assessment - Executive Function - Number of Overruns at Baseline	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the executive function - number of overruns domain, participants complete a maze task. Participants are assessed based on the cumulative number of 'overrun' errors made across all trials taken to complete the maze without error twice consecutively. Overrun errors are specifically when subjects continue pressing in the same direction of movement through the maze instead of turning where required.	Baseline
Secondary	WebNeuro Neurocognitive Assessment - Executive Function - Number of Overruns at Week 7	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the executive function - number of overruns domain, participants complete a maze task. Participants are assessed based on the cumulative number of 'overrun' errors made across all trials taken to complete the maze without error twice consecutively. Overrun errors are specifically when subjects continue pressing in the same direction of movement through the maze instead of turning where required.	Week 7
Secondary	WebNeuro Neurocognitive Assessment - Impulsivity - Reaction Time at Baseline	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the impulsivity - reaction time domain, participants complete a Go/No-Go task. Participants are assessed based on reaction time to spacebar press averaged across all correctly performed green "press" stimuli.	Baseline
Secondary	WebNeuro Neurocognitive Assessment - Impulsivity - Reaction Time at Week 7	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the impulsivity - reaction time domain, participants complete a Go/No-Go task. Participants are assessed based on reaction time to spacebar press averaged across all correctly performed green "press" stimuli.	Week 7
Secondary	WebNeuro Neurocognitive Assessment - Impulsivity - False Alarms at Baseline	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the impulsivity - false alarms domain, participants complete a Go/No-Go task. Participants are assessed based on the number of times when the spacebar was pressed at any time in response to a red "don't press" stimulus.	Baseline
Secondary	WebNeuro Neurocognitive Assessment - Impulsivity - False Alarms at Week 7	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the impulsivity - false alarms domain, participants complete a Go/No-Go task. Participants are assessed based on the number of times when the spacebar was pressed a1t any time in response to a red "don't press" stimulus.	Week 7
Secondary	WebNeuro Neurocognitive Assessment - Impulsivity - False Misses at Baseline	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the impulsivity - false misses domain, participants complete a Go/No-Go task. Participants are assessed based on the number of times when the spacebar was not pressed in response to a green "press" stimulus.	Week 7
Secondary	WebNeuro Neurocognitive Assessment - Impulsivity - False Misses at Week 7	WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the impulsivity - false misses domain, participants complete a Go/No-Go task. Participants are assessed based on the number of times when the spacebar was not pressed in response to a green "press" stimulus.	Week 7