Attention Deficit-HyperactivityPhase 3MYDAYISNCT03945175

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

A Phase 3 study testing MYDAYIS in people with Attention Deficit-Hyperactivity, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Attention-deficit/hyperactivity disorder (ADHD) is a neuropsychiatric disorder characterized by problems with sustaining attention, organization, planning, procrastination, daydreaming, restlessness, impulsivity and hyperactivity.This is an outpatient study for subjects between the ages of 18-60, who have an Attention… Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Attention Deficit-Hyperactivity
What is being tested?: MYDAYIS
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 52 participants
Where: 1 siteUnited States
Study dates: 15 Jul 2020to 11 May 2022
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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)

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

New York University School of Medicine
New York, New York, 10016

Other trials in United States

About this study

Read the 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.

Conditions: Attention Deficit-Hyperactivity
Being tested: MYDAYIS, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MYDAYISDrug
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.
PlaceboDrug
During the two-week, placebo lead-in, all patients will receive 12.5mg of placebo at Visit 1 and Visit 2.

Study groups in NCT03945175
Study group	Role	What they receive
Treatment	Experimental	After a two-week, single-blinded, placebo lead-in, all patients will receive four weeks of order-fixed treatment with Mydayis. Receives: Drug: MYDAYIS; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Week 6 (End of Mydayis Treatment)

Secondary outcomes (64)

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.
Measured: Week 2 (End of Placebo Lead-In)
AISRS: Overall Inattentive (IA) Symptom Subscale Score at End of Mydayis Treatment
The IA symptom subscale comprises 9 items of the AISRS measuring inattentive symptoms of ADHD. Items are ranked on a 4-point Likert scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The total IA subscale score ranges from 0 to 27; higher scores indicate more severe IA symptoms.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jul 202011 May 2022

First posted10 May 2019
Study start15 Jul 2020
Primary completion11 May 2022
Study completion11 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Attention Deficit-HyperactivityStudies of the same condition, open and under way.
More trials run by NYU Langone HealthThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03945175
Sponsor's protocol ID: 19-00046
Acronym: MYDAYIS
Status last verified: Mar 2024
First submitted: 6 May 2019
Last updated: 8 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of the Duration and Efficacy of MYDAYIS on Adult ADHD Symptoms and Executive Function Throughout the Day Into the Early Evening
ClinicalTrials.gov ID: NCT03945175
Acronym / sponsor ID: MYDAYIS / 19-00046
Conditions: Attention Deficit-Hyperactivity
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Study start: 15 Jul 2020 (actual)
Primary completion: 11 May 2022 (actual)
Study completion: 11 May 2022 (actual)
First posted: 10 May 2019 (actual)
Results: Posted 29 Jun 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment	Experimental	Drug: MYDAYIS, Drug: PlaceboAfter a two-week, single-blinded, placebo lead-in, all patients will receive four weeks of order-fixed treatment with Mydayis.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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)

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MYDAYISMYDAYIS treatment will be given at a minimum dose of 12.5mg/day and will increase in increments of 12.5mg, up to 37.5mg, based upon clinical response and tolerability.	Drug	Treatment
PlaceboDuring the two-week, placebo lead-in, all patients will receive 12.5mg of placebo at Visit 1 and Visit 2.	Drug	Treatment

Primary outcome

Adult ADHD Investigator Symptom Rating Scale (AISRS) Score at End of Placebo Lead-In
Time frame: 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
Time frame: 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.

64 secondary outcomes

AISRS: Overall Inattentive (IA) Symptom Subscale Score at End of Placebo Lead-In
Time frame: Week 2 (End of Placebo Lead-In)
AISRS: Overall Inattentive (IA) Symptom Subscale Score at End of Mydayis Treatment
Time frame: Week 6 (End of Mydayis Treatment)
AISRS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Placebo Lead-In
Time frame: Week 2 (End of Placebo Lead-In)
AISRS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Mydayis Treatment
Time frame: Week 6 (End of Mydayis Treatment)
Clinical Global Impression-Severity (CGI-S) Scale Score at End of Placebo Lead-In
Time frame: Week 2 (End of Placebo Lead-In)
Clinical Global Impression-Severity (CGI-S) Scale Score at End of Mydayis Treatment
Time frame: Week 6 (End of Mydayis Treatment)
14-Hour Post-Dose Time-Sensitive Adult ADHD Symptom Scale (TASS) Score at End of Placebo Lead-In
Time frame: Week 2 (End of Placebo Lead-In)
14-Hour Post-Dose Time-Sensitive Adult ADHD Symptom Scale (TASS) Score at End of Mydayis Treatment
Time frame: Week 6 (End of Mydayis Treatment)
14-hour Post-Dose TASS: Inattentive (IA) Symptom Subscale Score at End of Placebo Lead-In
Time frame: Week 2 (End of Placebo Lead-In)
14-hour Post-Dose TASS: Inattentive (IA) Symptom Subscale Score at End of Mydayis Treatment
Time frame: Week 6 (End of Mydayis Treatment)
14-hour Post-Dose TASS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Placebo Lead-In
Time frame: Week 2 (End of Placebo Lead-In)
14-hour Post-Dose TASS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Mydayis Treatment
Time frame: Week 6 (End of Mydayis Treatment)
Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Score at Week 3
Time frame: Week 3
Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Score at Week 7
Time frame: Week 7
WebNeuro Neurocognitive Assessment - Working Memory Capacity - Recall Span Score at Baseline
Time frame: Baseline
WebNeuro Neurocognitive Assessment - Working Memory Capacity - Recall Span Score at Week 7
Time frame: Week 7
WebNeuro Neurocognitive Assessment - Working Memory Capacity - Working Memory Accuracy at Baseline
Time frame: Baseline
WebNeuro Neurocognitive Assessment - Working Memory Capacity - Working Memory Accuracy at Week 7
Time frame: Week 7
WebNeuro Neurocognitive Assessment - Attention and Concentration - Reaction Time at Baseline
Time frame: Baseline
WebNeuro Neurocognitive Assessment - Attention and Concentration - Reaction Time at Week 7
Time frame: Week 7
WebNeuro Neurocognitive Assessment - Attention and Concentration - False Alarms at Baseline
Time frame: Baseline
WebNeuro Neurocognitive Assessment - Attention and Concentration - False Alarms at Week 7
Time frame: Week 7
WebNeuro Neurocognitive Assessment - Attention and Concentration - False Misses at Baseline
Time frame: Baseline
WebNeuro Neurocognitive Assessment - Attention and Concentration - False Misses at Week 7
Time frame: Week 7
WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Completion Time at Baseline
Time frame: Baseline
WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Completion Time at Week 7
Time frame: Week 7
WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Average Connection Time at Baseline
Time frame: Baseline
WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Average Connection Time at Week 7
Time frame: Week 7
WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors at Baseline
Time frame: Baseline
WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors at Week 7
Time frame: Week 7
WebNeuro Neurocognitive Assessment - Response Speed - Number of Taps at Baseline
Time frame: Baseline
WebNeuro Neurocognitive Assessment - Response Speed - Number of Taps at Week 7
Time frame: Week 7
WebNeuro Neurocognitive Assessment - Response Speed - Tapping Variability at Baseline
Time frame: Baseline
WebNeuro Neurocognitive Assessment - Response Speed - Tapping Variability at Week 7
Time frame: Week 7
WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time at Baseline
Time frame: Baseline
WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time at Week 7
Time frame: Week 7
WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Score (Words) at Baseline
Time frame: Baseline
WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Score (Words) at Week 7
Time frame: Week 7
WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors (Words) at Baseline
Time frame: Baseline
WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors (Words) at Week 7
Time frame: Week 7

Results and safety

Results posted to the registry on 29 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo, Then Mydayis	52	17

Primary outcome: Adult ADHD Investigator Symptom Rating Scale (AISRS) Score at End of Placebo Lead-In

Time frame: Week 2 (End of Placebo Lead-In). Mean (Standard Deviation). Unit: score on a scale

Measure	Placebo, Then Mydayis n = 18
Value	37.2 (11.4)

Primary outcome: Adult ADHD Investigator Symptom Rating Scale (AISRS) Score at End of Mydayis Treatment

Time frame: Week 6 (End of Mydayis Treatment). Mean (Standard Deviation). Unit: score on a scale

Measure	Placebo, Then Mydayis n = 18
Value	18.5 (8.9)

64 secondary outcomes are reported in the full results.

Adverse events

Time frame: 7 Weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo, Then Mydayis	0 of 18 (0%)	14 of 18 (77.8%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Related trials for Attention Deficit-Hyperactivity

Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lenard Adler, MD principal investigator

New York Langone Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MYDAYIS in people with Attention Deficit-Hyperactivity, run by NYU Langone Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adult ADHD Investigator Symptom Rating Scale (AISRS) Score at End of Placebo Lead-In (time frame: Week 2 (End of Placebo Lead-In)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03945175.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.