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

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit-Hyperactivity
• Intervention / Treatment: Drug: MYDAYIS; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; After a two-week, single-blinded, placebo lead-in, all patients will receive four weeks of order-fixed treatment with Mydayis.	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.; Drug: Placebo; During the two-week, placebo lead-in, all patients will receive 12.5mg of placebo at Visit 1 and Visit 2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Lenard Adler, MD, New York Langone Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2020
• Primary Completion (Actual): May 11, 2022
• Study Completion (Actual): May 11, 2022

Study Registration Dates

• First Submitted: May 6, 2019
• First Submitted That Met QC Criteria: May 7, 2019
• First Posted (Actual): May 10, 2019

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: 19-00046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No