Attention Deficit-Hyperactivity
Conditions
Brief 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.
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.
Interventions
DRUGMYDAYIS
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.
DRUGPlacebo
During the two-week, placebo lead-in, all patients will receive 12.5mg of placebo at Visit 1 and Visit 2.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adult ADHD Investigator Symptom Rating Scale (AISRS) Score at End of Placebo Lead-In | Week 2 (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. |
| Adult ADHD Investigator Symptom Rating Scale (AISRS) Score at End of Mydayis Treatment | Week 6 (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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AISRS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Placebo Lead-In | Week 2 (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. |
| AISRS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Mydayis Treatment | Week 6 (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. |
| Clinical Global Impression-Severity (CGI-S) Scale Score at End of Placebo Lead-In | Week 2 (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. |
| Clinical Global Impression-Severity (CGI-S) Scale Score at End of Mydayis Treatment | Week 6 (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. |
| 14-Hour Post-Dose Time-Sensitive Adult ADHD Symptom Scale (TASS) Score at End of Placebo Lead-In | Week 2 (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. |
| 14-Hour Post-Dose Time-Sensitive Adult ADHD Symptom Scale (TASS) Score at End of Mydayis Treatment | Week 6 (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. |
| 14-hour Post-Dose TASS: Inattentive (IA) Symptom Subscale Score at End of Placebo Lead-In | Week 2 (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. |
| 14-hour Post-Dose TASS: Inattentive (IA) Symptom Subscale Score at End of Mydayis Treatment | Week 6 (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. |
| 14-hour Post-Dose TASS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Placebo Lead-In | Week 2 (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. |
| 14-hour Post-Dose TASS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Mydayis Treatment | Week 6 (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. |
| Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Score at Week 3 | 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. |
| Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Score at Week 7 | 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. |
| WebNeuro Neurocognitive Assessment - Working Memory Capacity - Recall Span Score at Baseline | 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. |
| WebNeuro Neurocognitive Assessment - Working Memory Capacity - Recall Span Score at Week 7 | 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. |
| WebNeuro Neurocognitive Assessment - Working Memory Capacity - Working Memory Accuracy at Baseline | 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. |
| WebNeuro Neurocognitive Assessment - Working Memory Capacity - Working Memory Accuracy at Week 7 | 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. |
| WebNeuro Neurocognitive Assessment - Attention and Concentration - Reaction Time at Baseline | 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). |
| WebNeuro Neurocognitive Assessment - Attention and Concentration - Reaction Time at Week 7 | 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). |
| WebNeuro Neurocognitive Assessment - Attention and Concentration - False Alarms at Baseline | 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. |
| WebNeuro Neurocognitive Assessment - Attention and Concentration - False Alarms at Week 7 | 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. |
| WebNeuro Neurocognitive Assessment - Attention and Concentration - False Misses at Baseline | 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. |
| WebNeuro Neurocognitive Assessment - Attention and Concentration - False Misses at Week 7 | 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. |
| WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Completion Time at Baseline | 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. |
| WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Completion Time at Week 7 | 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. |
| WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Average Connection Time at Baseline | 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. |
| WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Average Connection Time at Week 7 | 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. |
| WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors at Baseline | 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. |
| WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors at Week 7 | 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. |
| WebNeuro Neurocognitive Assessment - Response Speed - Number of Taps at Baseline | 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. |
| WebNeuro Neurocognitive Assessment - Response Speed - Number of Taps at Week 7 | 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. |
| WebNeuro Neurocognitive Assessment - Response Speed - Tapping Variability at Baseline | 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. |
| WebNeuro Neurocognitive Assessment - Response Speed - Tapping Variability at Week 7 | 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. |
| WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time at Baseline | 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. |
| WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time at Week 7 | 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. |
| WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Score (Words) at Baseline | 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). |
| WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Score (Words) at Week 7 | 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). |
| WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors (Words) at Baseline | 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). |
| WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors (Words) at Week 7 | 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). |
| WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time (Words) at Baseline | 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). |
| WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time (Words) at Week 7 | 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). |
| WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Score (Colors) at Baseline | 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). |
| WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Score (Colors) at Week 7 | 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). |
| WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors (Colors) at Baseline | 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). |
| WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors (Colors) at Week 7 | 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). |
| WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time (Colors) at Baseline | 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). |
| WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time (Colors) at Week 7 | 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). |
| WebNeuro Neurocognitive Assessment - Executive Function - Trials Completed at Baseline | 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. |
| WebNeuro Neurocognitive Assessment - Executive Function - Trials Completed at Week 7 | 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. |
| WebNeuro Neurocognitive Assessment - Executive Function - Completion Time at Baseline | 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. |
| WebNeuro Neurocognitive Assessment - Executive Function - Completion Time at Week 7 | 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. |
| WebNeuro Neurocognitive Assessment - Executive Function - Path Learning Time at Baseline | 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. |
| WebNeuro Neurocognitive Assessment - Executive Function - Path Learning Time at Week 7 | 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. |
| WebNeuro Neurocognitive Assessment - Executive Function - Total Errors at Baseline | 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. |
| WebNeuro Neurocognitive Assessment - Executive Function - Total Errors at Week 7 | 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. |
| WebNeuro Neurocognitive Assessment - Executive Function - Number of Overruns at Baseline | 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. |
| AISRS: Overall Inattentive (IA) Symptom Subscale Score at End of Placebo Lead-In | Week 2 (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. |
| WebNeuro Neurocognitive Assessment - Impulsivity - Reaction Time at Baseline | 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. |
| WebNeuro Neurocognitive Assessment - Impulsivity - Reaction Time at Week 7 | 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. |
| WebNeuro Neurocognitive Assessment - Impulsivity - False Alarms at Baseline | 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. |
| WebNeuro Neurocognitive Assessment - Impulsivity - False Alarms at Week 7 | 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. |
| WebNeuro Neurocognitive Assessment - Impulsivity - False Misses at Baseline | 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. |
| WebNeuro Neurocognitive Assessment - Impulsivity - False Misses at Week 7 | 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. |
| WebNeuro Neurocognitive Assessment - Executive Function - Number of Overruns at Week 7 | 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. |
| AISRS: Overall Inattentive (IA) Symptom Subscale Score at End of Mydayis Treatment | Week 6 (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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo, Then Mydayis After a two-week, single-blinded, placebo lead-in, all patients will receive four weeks of order-fixed treatment with Mydayis.
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. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not meet inclusion criteria | 31 |
| Overall Study | Early termination during Mydayis treatment | 1 |
| Overall Study | Responded to Placebo Treatment and was not Allocated to Mydayis | 1 |
| Overall Study | Withdrew consent | 2 |
Baseline characteristics
| Characteristic | Placebo, Then Mydayis |
|---|---|
| Age, Continuous | 36.5 years STANDARD_DEVIATION 10.27 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 14 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
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.
Time frame: Week 6 (End of Mydayis Treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | Adult ADHD Investigator Symptom Rating Scale (AISRS) Score at End of Mydayis Treatment | 18.5 score on a scale | Standard Deviation 8.9 |
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.
Time frame: Week 2 (End of Placebo Lead-In)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | Adult ADHD Investigator Symptom Rating Scale (AISRS) Score at End of Placebo Lead-In | 37.2 score on a scale | Standard Deviation 11.4 |
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.
Time frame: Week 6 (End of Mydayis Treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | 14-hour Post-Dose TASS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Mydayis Treatment | 6.9 score on a scale | Standard Deviation 5.3 |
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.
Time frame: Week 2 (End of Placebo Lead-In)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | 14-hour Post-Dose TASS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Placebo Lead-In | 9.2 score on a scale | Standard Deviation 5.7 |
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.
Time frame: Week 6 (End of Mydayis Treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | 14-hour Post-Dose TASS: Inattentive (IA) Symptom Subscale Score at End of Mydayis Treatment | 9.8 score on a scale | Standard Deviation 6.3 |
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.
Time frame: Week 2 (End of Placebo Lead-In)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | 14-hour Post-Dose TASS: Inattentive (IA) Symptom Subscale Score at End of Placebo Lead-In | 15.4 score on a scale | Standard Deviation 5.5 |
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.
Time frame: Week 6 (End of Mydayis Treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | 14-Hour Post-Dose Time-Sensitive Adult ADHD Symptom Scale (TASS) Score at End of Mydayis Treatment | 16.8 score on a scale | Standard Deviation 10.8 |
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.
Time frame: Week 2 (End of Placebo Lead-In)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | 14-Hour Post-Dose Time-Sensitive Adult ADHD Symptom Scale (TASS) Score at End of Placebo Lead-In | 24.6 score on a scale | Standard Deviation 10.8 |
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.
Time frame: Week 6 (End of Mydayis Treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | AISRS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Mydayis Treatment | 8.8 score on a scale | Standard Deviation 5 |
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.
Time frame: Week 2 (End of Placebo Lead-In)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | AISRS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Placebo Lead-In | 17.3 score on a scale | Standard Deviation 5.8 |
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.
Time frame: Week 6 (End of Mydayis Treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | AISRS: Overall Inattentive (IA) Symptom Subscale Score at End of Mydayis Treatment | 9.6 score on a scale | Standard Deviation 4.7 |
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.
Time frame: Week 2 (End of Placebo Lead-In)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | AISRS: Overall Inattentive (IA) Symptom Subscale Score at End of Placebo Lead-In | 19.9 score on a scale | Standard Deviation 6.1 |
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.
Time frame: Week 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Score at Week 3 | 68.6 T-score | Standard Deviation 8.9 |
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.
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Score at Week 7 | 58.6 T-score | Standard Deviation 14.9 |
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.
Time frame: Week 6 (End of Mydayis Treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | Clinical Global Impression-Severity (CGI-S) Scale Score at End of Mydayis Treatment | 3.1 score on a scale | Standard Deviation 1 |
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.
Time frame: Week 2 (End of Placebo Lead-In)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | Clinical Global Impression-Severity (CGI-S) Scale Score at End of Placebo Lead-In | 4.6 score on a scale | Standard Deviation 0.8 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Attention and Concentration - False Alarms at Baseline | 1.3 Number of false alarms | Standard Deviation 1.2 |
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.
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Attention and Concentration - False Alarms at Week 7 | 1.0 Number of false alarms | Standard Deviation 1.3 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Attention and Concentration - False Misses at Baseline | 0.7 Number of false misses | Standard Deviation 0.9 |
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.
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Attention and Concentration - False Misses at Week 7 | 0.7 Number of false misses | Standard Deviation 1 |
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).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Attention and Concentration - Reaction Time at Baseline | 567.0 milliseconds | Standard Deviation 118 |
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).
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Attention and Concentration - Reaction Time at Week 7 | 566.3 milliseconds | Standard Deviation 145.4 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Executive Function - Completion Time at Baseline | 234774.9 milliseconds | Standard Deviation 87879.2 |
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.
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Executive Function - Completion Time at Week 7 | 174054.1 milliseconds | Standard Deviation 93675.1 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Executive Function - Number of Overruns at Baseline | 14.8 Number of incorrect moves | Standard Deviation 14.8 |
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.
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Executive Function - Number of Overruns at Week 7 | 12.8 Number of incorrect moves | Standard Deviation 7.3 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Executive Function - Path Learning Time at Baseline | 204859.7 milliseconds | Standard Deviation 81156.1 |
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.
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Executive Function - Path Learning Time at Week 7 | 148589.5 milliseconds | Standard Deviation 88469 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Executive Function - Total Errors at Baseline | 37.1 Number of incorrect moves | Standard Deviation 27 |
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.
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Executive Function - Total Errors at Week 7 | 26.3 Number of incorrect moves | Standard Deviation 13.1 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Executive Function - Trials Completed at Baseline | 9.5 Number of trials completed | Standard Deviation 4.8 |
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.
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Executive Function - Trials Completed at Week 7 | 8.1 Number of trials completed | Standard Deviation 3.9 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Impulsivity - False Alarms at Baseline | 6.1 Number of spacebar presses | Standard Deviation 3.5 |
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.
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Impulsivity - False Alarms at Week 7 | 5.2 Number of spacebar presses | Standard Deviation 3.6 |
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.
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Impulsivity - False Misses at Baseline | 1.9 Number of spacebar presses | Standard Deviation 2 |
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.
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Impulsivity - False Misses at Week 7 | 0.3 Number of spacebar presses | Standard Deviation 0.6 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Impulsivity - Reaction Time at Baseline | 308.2 milliseconds | Standard Deviation 63.6 |
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.
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Impulsivity - Reaction Time at Week 7 | 307.8 milliseconds | Standard Deviation 48.2 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Average Connection Time at Baseline | 2228.0 milliseconds | Standard Deviation 617.3 |
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.
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Average Connection Time at Week 7 | 1863.1 milliseconds | Standard Deviation 517.9 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Completion Time at Baseline | 56771.9 milliseconds | Standard Deviation 12548 |
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.
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Completion Time at Week 7 | 47752.6 milliseconds | Standard Deviation 12867.6 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors at Baseline | 0.8 Number of errors | Standard Deviation 1.2 |
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.
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors at Week 7 | 0.7 Number of errors | Standard Deviation 0.7 |
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).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors (Colors) at Baseline | 0.3 Number of incorrect trials | Standard Deviation 0.8 |
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).
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors (Colors) at Week 7 | 2.1 Number of incorrect trials | Standard Deviation 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).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors (Words) at Baseline | 0.2 Number of incorrect trials | Standard Deviation 0.8 |
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).
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors (Words) at Week 7 | 0.4 Number of incorrect trials | Standard Deviation 1.2 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time at Baseline | 379.2 milliseconds | Standard Deviation 38.5 |
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.
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time at Week 7 | 378.2 milliseconds | Standard Deviation 48.7 |
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).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time (Colors) at Baseline | 1526.8 milliseconds | Standard Deviation 399.2 |
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).
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time (Colors) at Week 7 | 1176.2 milliseconds | Standard Deviation 263.7 |
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).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time (Words) at Baseline | 1434.5 milliseconds | Standard Deviation 961.6 |
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).
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time (Words) at Week 7 | 1248.4 milliseconds | Standard Deviation 315.2 |
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).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Score (Colors) at Baseline | 12.8 Number of correct trials | Standard Deviation 4.2 |
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).
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Score (Colors) at Week 7 | 15.7 Number of correct trials | Standard Deviation 4.9 |
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).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Score (Words) at Baseline | 15.4 Number of correct trials | Standard Deviation 5.1 |
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).
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Score (Words) at Week 7 | 16.0 Number of correct trials | Standard Deviation 4 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Response Speed - Number of Taps at Baseline | 189.6 Number of taps | Standard Deviation 22.2 |
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.
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Response Speed - Number of Taps at Week 7 | 189.9 Number of taps | Standard Deviation 20 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Response Speed - Tapping Variability at Baseline | 24.4 milliseconds | Standard Deviation 7.8 |
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.
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Response Speed - Tapping Variability at Week 7 | 30.4 milliseconds | Standard Deviation 24.2 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Working Memory Capacity - Recall Span Score at Baseline | 5.8 digits | Standard Deviation 2 |
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.
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Working Memory Capacity - Recall Span Score at Week 7 | 6.4 score on a scale | Standard Deviation 1.2 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Working Memory Capacity - Working Memory Accuracy at Baseline | 6.9 trials correct | Standard Deviation 3.2 |
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.
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Mydayis | WebNeuro Neurocognitive Assessment - Working Memory Capacity - Working Memory Accuracy at Week 7 | 7.7 trials correct | Standard Deviation 2.1 |