Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | After a two-week, single-blinded, placebo lead-in, all patients will receive four weeks of order-fixed treatment with Mydayis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MYDAYIS | Drug | 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. |
| 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) |
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lenard Adler, MD | New York Langone Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data.
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Week 2 (End of Placebo Lead-In) |
|
7 Weeks
Participants monitored weekly for abnormal vital signs, adverse events, and concomitant medications.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Terry Leon | NYU Langone Health | 646 754 4837 | terry.leon@nyulangone.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 2, 2021 | Jun 2, 2023 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | During the two-week, placebo lead-in, all patients will receive 12.5mg of placebo at Visit 1 and Visit 2. |
|
| 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 |
| Early termination during Mydayis treatment |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Week 6 (End of Mydayis Treatment) |
|
|
|
| Secondary | AISRS: Overall Inattentive (IA) Symptom Subscale Score at End of Placebo Lead-In | The IA symptom subscale comprises 9 items of the AISRS measuring inattentive symptoms of ADHD. Items are ranked on a 4-point Likert scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The total IA subscale score ranges from 0 to 27; higher scores indicate more severe IA symptoms. | Posted | Mean | Standard Deviation | score on a scale | Week 2 (End of Placebo Lead-In) |
|
|
|
| Secondary | AISRS: Overall Inattentive (IA) Symptom Subscale Score at End of Mydayis Treatment | The IA symptom subscale comprises 9 items of the AISRS measuring inattentive symptoms of ADHD. Items are ranked on a 4-point Likert scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The total IA subscale score ranges from 0 to 27; higher scores indicate more severe IA symptoms. | Posted | Mean | Standard Deviation | score on a scale | Week 6 (End of Mydayis Treatment) |
|
|
|
| Secondary | AISRS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Placebo Lead-In | The HI symptom subscale comprises 9 items of the AISRS measuring hyperactive-impulsive symptoms of ADHD. Items are ranked on a 4-point Likert scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The total IA subscale score ranges from 0 to 27; higher scores indicate more severe HI symptoms. | Posted | Mean | Standard Deviation | score on a scale | Week 2 (End of Placebo Lead-In) |
|
|
|
| Secondary | AISRS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Mydayis Treatment | The HI symptom subscale comprises 9 items of the AISRS measuring hyperactive-impulsive symptoms of ADHD. Items are ranked on a 4-point Likert scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The total IA subscale score ranges from 0 to 27; higher scores indicate more severe HI symptoms. | Posted | Mean | Standard Deviation | score on a scale | Week 6 (End of Mydayis Treatment) |
|
|
|
| Secondary | Clinical Global Impression-Severity (CGI-S) Scale Score at End of Placebo Lead-In | 7-item questionnaire requiring a clinician to rate the severity of a patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. The ratings range from 1-7, where: 1 = Normal, not at all ill; 2 = Borderline mentally ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; and 7 = Among the most extremely ill patients. | Posted | Mean | Standard Deviation | score on a scale | Week 2 (End of Placebo Lead-In) |
|
|
|
| Secondary | Clinical Global Impression-Severity (CGI-S) Scale Score at End of Mydayis Treatment | 7-item questionnaire requiring a clinician to rate the severity of a patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. The ratings range from 1-7, where: 1 = Normal, not at all ill; 2 = Borderline mentally ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; and 7 = Among the most extremely ill patients. | Posted | Mean | Standard Deviation | score on a scale | Week 6 (End of Mydayis Treatment) |
|
|
|
| Secondary | 14-Hour Post-Dose Time-Sensitive Adult ADHD Symptom Scale (TASS) Score at End of Placebo Lead-In | 18-item assessment of the severity of ADHD symptoms administered 14 hours after morning dosing. Items are ranked on a 4-point Likert scale: 0 (not at all), 1 (mild), 2 (moderate), 3 (severe). The total score is the sum of all the items on the scale and ranges from 0 to 54. A higher total score indicates more severe ADHD. | Posted | Mean | Standard Deviation | score on a scale | Week 2 (End of Placebo Lead-In) |
|
|
|
| Secondary | 14-Hour Post-Dose Time-Sensitive Adult ADHD Symptom Scale (TASS) Score at End of Mydayis Treatment | 18-item assessment of the severity of ADHD symptoms administered 14 hours after morning dosing. Items are ranked on a 4-point Likert scale: 0 (not at all), 1 (mild), 2 (moderate), 3 (severe). The total score is the sum of all the items on the scale and ranges from 0 to 54. A higher total score indicates more severe ADHD. | Posted | Mean | Standard Deviation | score on a scale | Week 6 (End of Mydayis Treatment) |
|
|
|
| Secondary | 14-hour Post-Dose TASS: Inattentive (IA) Symptom Subscale Score at End of Placebo Lead-In | The IA symptom subscale comprises 9 items of the TASS measuring inattentive symptoms of ADHD. Items are ranked on a 4-point Likert scale: 0 (not at all), 1 (mild), 2 (moderate), 3 (severe). The total IA subscale score ranges from 0 to 27; higher scores indicate more severe IA symptoms. Administered 14 hours after morning dosing. | Posted | Mean | Standard Deviation | score on a scale | Week 2 (End of Placebo Lead-In) |
|
|
|
| Secondary | 14-hour Post-Dose TASS: Inattentive (IA) Symptom Subscale Score at End of Mydayis Treatment | The IA symptom subscale comprises 9 items of the TASS measuring inattentive symptoms of ADHD. Items are ranked on a 4-point Likert scale: 0 (not at all), 1 (mild), 2 (moderate), 3 (severe). The total IA subscale score ranges from 0 to 27; higher scores indicate more severe IA symptoms. Administered 14 hours after morning dosing. | Posted | Mean | Standard Deviation | score on a scale | Week 6 (End of Mydayis Treatment) |
|
|
|
| Secondary | 14-hour Post-Dose TASS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Placebo Lead-In | The HI symptom subscale comprises 9 items of the TASS measuring inattentive symptoms of ADHD. Items are ranked on a 4-point Likert scale: 0 (not at all), 1 (mild), 2 (moderate), 3 (severe). The total IA subscale score ranges from 0 to 27; higher scores indicate more severe HI symptoms. Administered 14 hours after morning dosing. | Posted | Mean | Standard Deviation | score on a scale | Week 2 (End of Placebo Lead-In) |
|
|
|
| Secondary | 14-hour Post-Dose TASS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Mydayis Treatment | The HI symptom subscale comprises 9 items of the TASS measuring inattentive symptoms of ADHD. Items are ranked on a 4-point Likert scale: 0 (not at all), 1 (mild), 2 (moderate), 3 (severe). The total IA subscale score ranges from 0 to 27; higher scores indicate more severe HI symptoms. Administered 14 hours after morning dosing. | Posted | Mean | Standard Deviation | score on a scale | Week 6 (End of Mydayis Treatment) |
|
|
|
| Secondary | Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Score at Week 3 | 75-item questionnaire measuring an adult's cognitive, emotional, and behavioral functions within the past month. Items ranked on 3-point Likert scale (1 = Never, 2 = Sometimes, 3 = Often). Raw scores are calculated and used to generate T-scores for 8 scales (Inhibit; Shift; Emotional Control; Initiate; Working Memory; Plan/Organize; Task Monitor; and Organization of Materials), 2 summary index scales (Behavioral Regulation Index and Metacognition Index), and 1 scale reflecting overall functioning (Global Executive Composite). T-scores range from 30 to 100, with scores ≥65 indicating clinical impairment. | Posted | Mean | Standard Deviation | T-score | Week 3 |
|
|
|
| Secondary | Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Score at Week 7 | 75-item questionnaire measuring an adult's cognitive, emotional, and behavioral functions within the past month. Items ranked on 3-point Likert scale (1 = Never, 2 = Sometimes, 3 = Often). Raw scores are calculated and used to generate T-scores for 8 scales (Inhibit; Shift; Emotional Control; Initiate; Working Memory; Plan/Organize; Task Monitor; and Organization of Materials), 2 summary index scales (Behavioral Regulation Index and Metacognition Index), and 1 scale reflecting overall functioning (Global Executive Composite). T-scores range from 30 to 100, with scores ≥65 indicating clinical impairment. | Posted | Mean | Standard Deviation | T-score | Week 7 |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Working Memory Capacity - Recall Span Score at Baseline | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the working memory capacity - recall span domain, participants complete forward digit span task and are assessed based on the maximum length of a sequence of visually presented digits able to be entered on a keypad in correct order. The total score is the maximum length of the sequence of digits. | Posted | Mean | Standard Deviation | digits | Baseline |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Working Memory Capacity - Recall Span Score at Week 7 | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the working memory capacity - recall span domain, participants complete forward digit span task and are assessed based on the maximum length of a sequence of visually presented digits able to be entered on a keypad in correct order. The total score is the maximum length of the sequence of digits. | Posted | Mean | Standard Deviation | score on a scale | Week 7 |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Working Memory Capacity - Working Memory Accuracy at Baseline | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the working memory capacity - working memory accuracy domain, participants complete a digit span task. Participants are assessed based on the total number of correct trials in the forward digit span task where each incremental span length has two trials- at least one of which needs to be recalled correctly to progress. | Posted | Mean | Standard Deviation | trials correct | Baseline |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Working Memory Capacity - Working Memory Accuracy at Week 7 | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the working memory capacity - working memory accuracy domain, participants complete a digit span task. Participants are assessed based on the total number of correct trials in the forward digit span task where each incremental span length has two trials- at least one of which needs to be recalled correctly to progress. | Posted | Mean | Standard Deviation | trials correct | Week 7 |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Attention and Concentration - Reaction Time at Baseline | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the attention and concentration - reaction time domain, participants complete a continuous performance test. Participants are assessed based on their reaction time to space-bar presses, averaged across all correctly identified target stimuli (same letter presented twice in a row). | Posted | Mean | Standard Deviation | milliseconds | Baseline |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Attention and Concentration - Reaction Time at Week 7 | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the attention and concentration - reaction time domain, participants complete a continuous performance test. Participants are assessed based on their reaction time to space-bar presses, averaged across all correctly identified target stimuli (same letter presented twice in a row). | Posted | Mean | Standard Deviation | milliseconds | Week 7 |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Attention and Concentration - False Alarms at Baseline | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the attention and concentration - false alarms domain, participants complete a continuous performance test. Participants are assessed based on the number of times the space-bar was pressed at any time not in response to a "target" stimulus. | Posted | Mean | Standard Deviation | Number of false alarms | Baseline |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Attention and Concentration - False Alarms at Week 7 | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the attention and concentration - false alarms domain, participants complete a continuous performance test. Participants are assessed based on the number of times the space-bar was pressed at any time not in response to a "target" stimulus. | Posted | Mean | Standard Deviation | Number of false alarms | Week 7 |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Attention and Concentration - False Misses at Baseline | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the attention and concentration - false misses domain, participants complete a continuous performance test. Participants are assessed based on the number of times when the space-bar was NOT pressed following a target stimulus. | Posted | Mean | Standard Deviation | Number of false misses | Baseline |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Attention and Concentration - False Misses at Week 7 | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the attention and concentration - false misses domain, participants complete a continuous performance test. Participants are assessed based on the number of times when the space-bar was NOT pressed following a target stimulus. | Posted | Mean | Standard Deviation | Number of false misses | Week 7 |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Completion Time at Baseline | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - completion time domain, participants complete a switching of attention task. Participants are assessed based on the total amount of time taken to complete the whole sequence of digits and letters. | Posted | Mean | Standard Deviation | milliseconds | Baseline |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Completion Time at Week 7 | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - completion time domain, participants complete a switching of attention task. Participants are assessed based on the total amount of time taken to complete the whole sequence of digits and letters. | Posted | Mean | Standard Deviation | milliseconds | Week 7 |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Average Connection Time at Baseline | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - average connection time domain, participants complete a switching of attention task. Participants are assessed based on the average time between correct responses. | Posted | Mean | Standard Deviation | milliseconds | Baseline |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Average Connection Time at Week 7 | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - average connection time domain, participants complete a switching of attention task. Participants are assessed based on the average time between correct responses. | Posted | Mean | Standard Deviation | milliseconds | Week 7 |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors at Baseline | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - errors domain, participants complete a switching of attention task. Participants are assessed based on the number of times an incorrect digit or letter in the sequence was pressed. | Posted | Mean | Standard Deviation | Number of errors | Baseline |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors at Week 7 | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - errors domain, participants complete a switching of attention task. Participants are assessed based on the number of times an incorrect digit or letter in the sequence was pressed. | Posted | Mean | Standard Deviation | Number of errors | Week 7 |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Response Speed - Number of Taps at Baseline | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the response speed - number of taps domain, participants complete a motor tapping task. Participants are assessed based on the number of times they were able to tap the spacebar in 30 seconds with their dominant hand. | Posted | Mean | Standard Deviation | Number of taps | Baseline |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Response Speed - Number of Taps at Week 7 | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the response speed - number of taps domain, participants complete a motor tapping task. Participants are assessed based on the number of times they were able to tap the spacebar in 30 seconds with their dominant hand. | Posted | Mean | Standard Deviation | Number of taps | Week 7 |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Response Speed - Tapping Variability at Baseline | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the response speed - tapping variability domain, participants complete a motor tapping task. Participants are assessed based on the standard deviation of the time interval between taps on the space-bar for the dominant hand. | Posted | Mean | Standard Deviation | milliseconds | Baseline |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Response Speed - Tapping Variability at Week 7 | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the response speed - tapping variability domain, participants complete a motor tapping task. Participants are assessed based on the standard deviation of the time interval between taps on the space-bar for the dominant hand. | Posted | Mean | Standard Deviation | milliseconds | Week 7 |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time at Baseline | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - reaction time domain, participants complete a choice reaction time task. Participants are assessed based on the average time taken to press the left or right arrow to correspond with which circle (left or right) is highlighted in each trial. | Posted | Mean | Standard Deviation | milliseconds | Baseline |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time at Week 7 | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - reaction time domain, participants complete a choice reaction time task. Participants are assessed based on the average time taken to press the left or right arrow to correspond with which circle (left or right) is highlighted in each trial. | Posted | Mean | Standard Deviation | milliseconds | Week 7 |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Score (Words) at Baseline | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - score (words) domain, participants complete a verbal interference (word) task. Participants are assessed based on the number of stimuli for which the name of the color-word was correctly selected (ignoring the font-color of the word) in the time limit of 30 seconds (i.e., a higher score reflects greater speed). | Posted | Mean | Standard Deviation | Number of correct trials | Baseline |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Score (Words) at Week 7 | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - score (words) domain, participants complete a verbal interference (word) task. Participants are assessed based on the number of stimuli for which the name of the color-word was correctly selected (ignoring the font-color of the word) in the time limit of 30 seconds (i.e., a higher score reflects greater speed). | Posted | Mean | Standard Deviation | Number of correct trials | Week 7 |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors (Words) at Baseline | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - errors (words) domain, participants complete a verbal interference (word) task. Participants are assessed based on the number of stimuli for which the name of the color-word was incorrectly selected (ignoring the font-color of the word) in the time limit of 30 seconds (i.e., a higher score reflects more errors). | Posted | Mean | Standard Deviation | Number of incorrect trials | Baseline |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors (Words) at Week 7 | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - errors (words) domain, participants complete a verbal interference (word) task. Participants are assessed based on the number of stimuli for which the name of the color-word was incorrectly selected (ignoring the font-color of the word) in the time limit of 30 seconds (i.e., a higher score reflects more errors). | Posted | Mean | Standard Deviation | Number of incorrect trials | Week 7 |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time (Words) at Baseline | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - reaction time (words) domain, participants complete a verbal interference (word) task. Participants are assessed based on the average reaction time for the stimuli for which the name of the color-word was correctly selected (ignoring the font-color of the word). | Posted | Mean | Standard Deviation | milliseconds | Baseline |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time (Words) at Week 7 | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - reaction time (words) domain, participants complete a verbal interference (word) task. Participants are assessed based on the average reaction time for the stimuli for which the name of the color-word was correctly selected (ignoring the font-color of the word). | Posted | Mean | Standard Deviation | milliseconds | Week 7 |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Score (Colors) at Baseline | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - score (colors) domain, participants complete a verbal interference (color) task. Participants are assessed based on the number of stimuli for which the font-color of the color-word was correctly selected (ignoring the name of the word) in the time limit of 30 seconds (i.e., a higher score reflects greater speed). | Posted | Mean | Standard Deviation | Number of correct trials | Baseline |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Score (Colors) at Week 7 | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - score (colors) domain, participants complete a verbal interference (color) task. Participants are assessed based on the number of stimuli for which the font-color of the color-word was correctly selected (ignoring the name of the word) in the time limit of 30 seconds (i.e., a higher score reflects greater speed). | Posted | Mean | Standard Deviation | Number of correct trials | Week 7 |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors (Colors) at Baseline | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - errors (colors) domain, participants complete a verbal interference (color) task. Participants are assessed based on the number of stimuli for which the font-color of the color-word was incorrectly selected (ignoring the name of the word) in the time limit of 30 seconds (i.e., a higher score reflects more errors). | Posted | Mean | Standard Deviation | Number of incorrect trials | Baseline |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors (Colors) at Week 7 | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - errors (colors) domain, participants complete a verbal interference (color) task. Participants are assessed based on the number of stimuli for which the font-color of the color-word was incorrectly selected (ignoring the name of the word) in the time limit of 30 seconds (i.e., a higher score reflects more errors). | Posted | Mean | Standard Deviation | Number of incorrect trials | Week 7 |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time (Colors) at Baseline | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - reaction time (colors) domain, participants complete a verbal interference (color) task. Participants are assessed based on the average reaction time for the stimuli for which the font-color of the color-word was correctly selected (ignoring the name of the word). | Posted | Mean | Standard Deviation | milliseconds | Baseline |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time (Colors) at Week 7 | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the information processing efficiency - reaction time (colors) domain, participants complete a verbal interference (color) task. Participants are assessed based on the average reaction time for the stimuli for which the font-color of the color-word was correctly selected (ignoring the name of the word). | Posted | Mean | Standard Deviation | milliseconds | Week 7 |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Executive Function - Trials Completed at Baseline | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the executive function - trials completed domain, participants complete a maze task. Participants are assessed based on the number of trials taken to successfully complete the maze without error twice consecutively. | Posted | Mean | Standard Deviation | Number of trials completed | Baseline |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Executive Function - Trials Completed at Week 7 | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the executive function - trials completed domain, participants complete a maze task. Participants are assessed based on the number of trials taken to successfully complete the maze without error twice consecutively. | Posted | Mean | Standard Deviation | Number of trials completed | Week 7 |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Executive Function - Completion Time at Baseline | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the executive function - completion time domain, participants complete a maze task. Participants are assessed based on the time taken to successfully complete the maze without error twice consecutively. | Posted | Mean | Standard Deviation | milliseconds | Baseline |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Executive Function - Completion Time at Week 7 | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the executive function - completion time domain, participants complete a maze task. Participants are assessed based on the time taken to successfully complete the maze without error twice consecutively. | Posted | Mean | Standard Deviation | milliseconds | Week 7 |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Executive Function - Path Learning Time at Baseline | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the executive function - path learning time domain, participants complete a maze task. Participants are assessed based on the time taken to the end of the final trial with at least one error- just before successfully completing the maze without error twice consecutively. | Posted | Mean | Standard Deviation | milliseconds | Baseline |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Executive Function - Path Learning Time at Week 7 | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the executive function - path learning time domain, participants complete a maze task. Participants are assessed based on the time taken to the end of the final trial with at least one error- just before successfully completing the maze without error twice consecutively. | Posted | Mean | Standard Deviation | milliseconds | Week 7 |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Executive Function - Total Errors at Baseline | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the executive function - total errors domain, participants complete a maze task. Participants are assessed based on the cumulative number of all types of errors made across all trials taken to complete the maze without error twice consecutively. | Posted | Mean | Standard Deviation | Number of incorrect moves | Baseline |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Executive Function - Total Errors at Week 7 | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the executive function - total errors domain, participants complete a maze task. Participants are assessed based on the cumulative number of all types of errors made across all trials taken to complete the maze without error twice consecutively. | Posted | Mean | Standard Deviation | Number of incorrect moves | Week 7 |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Executive Function - Number of Overruns at Baseline | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the executive function - number of overruns domain, participants complete a maze task. Participants are assessed based on the cumulative number of 'overrun' errors made across all trials taken to complete the maze without error twice consecutively. Overrun errors are specifically when subjects continue pressing in the same direction of movement through the maze instead of turning where required. | Posted | Mean | Standard Deviation | Number of incorrect moves | Baseline |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Executive Function - Number of Overruns at Week 7 | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the executive function - number of overruns domain, participants complete a maze task. Participants are assessed based on the cumulative number of 'overrun' errors made across all trials taken to complete the maze without error twice consecutively. Overrun errors are specifically when subjects continue pressing in the same direction of movement through the maze instead of turning where required. | Posted | Mean | Standard Deviation | Number of incorrect moves | Week 7 |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Impulsivity - Reaction Time at Baseline | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the impulsivity - reaction time domain, participants complete a Go/No-Go task. Participants are assessed based on reaction time to spacebar press averaged across all correctly performed green "press" stimuli. | Posted | Mean | Standard Deviation | milliseconds | Baseline |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Impulsivity - Reaction Time at Week 7 | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the impulsivity - reaction time domain, participants complete a Go/No-Go task. Participants are assessed based on reaction time to spacebar press averaged across all correctly performed green "press" stimuli. | Posted | Mean | Standard Deviation | milliseconds | Week 7 |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Impulsivity - False Alarms at Baseline | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the impulsivity - false alarms domain, participants complete a Go/No-Go task. Participants are assessed based on the number of times when the spacebar was pressed at any time in response to a red "don't press" stimulus. | Posted | Mean | Standard Deviation | Number of spacebar presses | Baseline |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Impulsivity - False Alarms at Week 7 | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the impulsivity - false alarms domain, participants complete a Go/No-Go task. Participants are assessed based on the number of times when the spacebar was pressed a1t any time in response to a red "don't press" stimulus. | Posted | Mean | Standard Deviation | Number of spacebar presses | Week 7 |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Impulsivity - False Misses at Baseline | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the impulsivity - false misses domain, participants complete a Go/No-Go task. Participants are assessed based on the number of times when the spacebar was not pressed in response to a green "press" stimulus. | Posted | Mean | Standard Deviation | Number of spacebar presses | Week 7 |
|
|
|
| Secondary | WebNeuro Neurocognitive Assessment - Impulsivity - False Misses at Week 7 | WebNeuro is a web-based computerized battery of several domains of neurocognitive functioning. In the impulsivity - false misses domain, participants complete a Go/No-Go task. Participants are assessed based on the number of times when the spacebar was not pressed in response to a green "press" stimulus. | Posted | Mean | Standard Deviation | Number of spacebar presses | Week 7 |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 14 |
| 18 |
| Pain - Arm | General disorders | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Allergic Reaction | Immune system disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Burn | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
|
| COVID-19 | General disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Erectile Dysfunction | Reproductive system and breast disorders | Systematic Assessment |
|
| Other - Increased Appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pain - Foot | General disorders | Systematic Assessment |
|
| Agitation | Psychiatric disorders | Systematic Assessment |
|
| Concentration impairment | Nervous system disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided