Trial Outcomes & Findings for Study of the Duration and Efficacy of MYDAYIS on Adult ADHD Symptoms and Executive Function Throughout the Day Into the Early Evening (NCT NCT03945175)

NCT ID: NCT03945175

Last Updated: 2024-03-08

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 52 participants
• Primary outcome timeframe: Week 2 (End of Placebo Lead-In)
• Results posted on: 2024-03-08

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	52
Overall Study Participants Who Met Inclusion Criteria	21
Overall Study Participants Allocated to Single-Blind Placebo Treatment	21
Overall Study Participants Who Completed Single-Blind Placebo Treatment	20
Overall Study Participants Allocated to Mydayis Treatment	18
Overall Study Participants Included in Analysis of Outcome Measures	18
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	35

Reasons for withdrawal

Measure	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.
Overall Study Did not meet inclusion criteria	31
Overall Study Withdrew consent	2
Overall Study Responded to Placebo Treatment and was not Allocated to Mydayis	1
Overall Study Early termination during Mydayis treatment	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Placebo, Then Mydayis n=20 Participants 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.
Age, Continuous	36.5 years STANDARD_DEVIATION 10.27 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

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

37.2 score on a scale Standard Deviation 11.4

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

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

18.5 score on a scale Standard Deviation 8.9

SECONDARY outcome

Timeframe: Week 2 (End of Placebo Lead-In)

The IA symptom subscale comprises 9 items of the AISRS measuring inattentive symptoms of ADHD. Items are ranked on a 4-point Likert scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The total IA subscale score ranges from 0 to 27; higher scores indicate more severe IA symptoms.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

AISRS: Overall Inattentive (IA) Symptom Subscale Score at End of Placebo Lead-In

19.9 score on a scale Standard Deviation 6.1

SECONDARY outcome

Timeframe: Week 6 (End of Mydayis Treatment)

The IA symptom subscale comprises 9 items of the AISRS measuring inattentive symptoms of ADHD. Items are ranked on a 4-point Likert scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The total IA subscale score ranges from 0 to 27; higher scores indicate more severe IA symptoms.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

AISRS: Overall Inattentive (IA) Symptom Subscale Score at End of Mydayis Treatment

9.6 score on a scale Standard Deviation 4.7

SECONDARY outcome

Timeframe: Week 2 (End of Placebo Lead-In)

The HI symptom subscale comprises 9 items of the AISRS measuring hyperactive-impulsive symptoms of ADHD. Items are ranked on a 4-point Likert scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The total IA subscale score ranges from 0 to 27; higher scores indicate more severe HI symptoms.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

AISRS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Placebo Lead-In

17.3 score on a scale Standard Deviation 5.8

SECONDARY outcome

Timeframe: Week 6 (End of Mydayis Treatment)

The HI symptom subscale comprises 9 items of the AISRS measuring hyperactive-impulsive symptoms of ADHD. Items are ranked on a 4-point Likert scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The total IA subscale score ranges from 0 to 27; higher scores indicate more severe HI symptoms.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

AISRS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Mydayis Treatment

8.8 score on a scale Standard Deviation 5.0

SECONDARY outcome

Timeframe: Week 2 (End of Placebo Lead-In)

7-item questionnaire requiring a clinician to rate the severity of a patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. The ratings range from 1-7, where: 1 = Normal, not at all ill; 2 = Borderline mentally ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; and 7 = Among the most extremely ill patients.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

Clinical Global Impression-Severity (CGI-S) Scale Score at End of Placebo Lead-In

4.6 score on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: Week 6 (End of Mydayis Treatment)

7-item questionnaire requiring a clinician to rate the severity of a patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. The ratings range from 1-7, where: 1 = Normal, not at all ill; 2 = Borderline mentally ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; and 7 = Among the most extremely ill patients.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

Clinical Global Impression-Severity (CGI-S) Scale Score at End of Mydayis Treatment

3.1 score on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: Week 2 (End of Placebo Lead-In)

18-item assessment of the severity of ADHD symptoms administered 14 hours after morning dosing. Items are ranked on a 4-point Likert scale: 0 (not at all), 1 (mild), 2 (moderate), 3 (severe). The total score is the sum of all the items on the scale and ranges from 0 to 54. A higher total score indicates more severe ADHD.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

14-Hour Post-Dose Time-Sensitive Adult ADHD Symptom Scale (TASS) Score at End of Placebo Lead-In

24.6 score on a scale Standard Deviation 10.8

SECONDARY outcome

Timeframe: Week 6 (End of Mydayis Treatment)

18-item assessment of the severity of ADHD symptoms administered 14 hours after morning dosing. Items are ranked on a 4-point Likert scale: 0 (not at all), 1 (mild), 2 (moderate), 3 (severe). The total score is the sum of all the items on the scale and ranges from 0 to 54. A higher total score indicates more severe ADHD.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

14-Hour Post-Dose Time-Sensitive Adult ADHD Symptom Scale (TASS) Score at End of Mydayis Treatment

16.8 score on a scale Standard Deviation 10.8

SECONDARY outcome

Timeframe: Week 2 (End of Placebo Lead-In)

The IA symptom subscale comprises 9 items of the TASS measuring inattentive symptoms of ADHD. Items are ranked on a 4-point Likert scale: 0 (not at all), 1 (mild), 2 (moderate), 3 (severe). The total IA subscale score ranges from 0 to 27; higher scores indicate more severe IA symptoms. Administered 14 hours after morning dosing.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

14-hour Post-Dose TASS: Inattentive (IA) Symptom Subscale Score at End of Placebo Lead-In

15.4 score on a scale Standard Deviation 5.5

SECONDARY outcome

Timeframe: Week 6 (End of Mydayis Treatment)

The IA symptom subscale comprises 9 items of the TASS measuring inattentive symptoms of ADHD. Items are ranked on a 4-point Likert scale: 0 (not at all), 1 (mild), 2 (moderate), 3 (severe). The total IA subscale score ranges from 0 to 27; higher scores indicate more severe IA symptoms. Administered 14 hours after morning dosing.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

14-hour Post-Dose TASS: Inattentive (IA) Symptom Subscale Score at End of Mydayis Treatment

9.8 score on a scale Standard Deviation 6.3

SECONDARY outcome

Timeframe: Week 2 (End of Placebo Lead-In)

The HI symptom subscale comprises 9 items of the TASS measuring inattentive symptoms of ADHD. Items are ranked on a 4-point Likert scale: 0 (not at all), 1 (mild), 2 (moderate), 3 (severe). The total IA subscale score ranges from 0 to 27; higher scores indicate more severe HI symptoms. Administered 14 hours after morning dosing.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

14-hour Post-Dose TASS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Placebo Lead-In

9.2 score on a scale Standard Deviation 5.7

SECONDARY outcome

Timeframe: Week 6 (End of Mydayis Treatment)

The HI symptom subscale comprises 9 items of the TASS measuring inattentive symptoms of ADHD. Items are ranked on a 4-point Likert scale: 0 (not at all), 1 (mild), 2 (moderate), 3 (severe). The total IA subscale score ranges from 0 to 27; higher scores indicate more severe HI symptoms. Administered 14 hours after morning dosing.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

14-hour Post-Dose TASS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Mydayis Treatment

6.9 score on a scale Standard Deviation 5.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Score at Week 3

68.6 T-score Standard Deviation 8.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Score at Week 7

58.6 T-score Standard Deviation 14.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Working Memory Capacity - Recall Span Score at Baseline

5.8 digits Standard Deviation 2.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Working Memory Capacity - Recall Span Score at Week 7

6.4 score on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Working Memory Capacity - Working Memory Accuracy at Baseline

6.9 trials correct Standard Deviation 3.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Working Memory Capacity - Working Memory Accuracy at Week 7

7.7 trials correct Standard Deviation 2.1

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Attention and Concentration - Reaction Time at Baseline

567.0 milliseconds Standard Deviation 118.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Attention and Concentration - Reaction Time at Week 7

566.3 milliseconds Standard Deviation 145.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Attention and Concentration - False Alarms at Baseline

1.3 Number of false alarms Standard Deviation 1.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Attention and Concentration - False Alarms at Week 7

1.0 Number of false alarms Standard Deviation 1.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Attention and Concentration - False Misses at Baseline

0.7 Number of false misses Standard Deviation 0.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Attention and Concentration - False Misses at Week 7

0.7 Number of false misses Standard Deviation 1.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Completion Time at Baseline

56771.9 milliseconds Standard Deviation 12548.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Completion Time at Week 7

47752.6 milliseconds Standard Deviation 12867.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Average Connection Time at Baseline

2228.0 milliseconds Standard Deviation 617.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Average Connection Time at Week 7

1863.1 milliseconds Standard Deviation 517.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors at Baseline

0.8 Number of errors Standard Deviation 1.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors at Week 7

0.7 Number of errors Standard Deviation 0.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Response Speed - Number of Taps at Baseline

189.6 Number of taps Standard Deviation 22.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Response Speed - Number of Taps at Week 7

189.9 Number of taps Standard Deviation 20.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Response Speed - Tapping Variability at Baseline

24.4 milliseconds Standard Deviation 7.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Response Speed - Tapping Variability at Week 7

30.4 milliseconds Standard Deviation 24.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time at Baseline

379.2 milliseconds Standard Deviation 38.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time at Week 7

378.2 milliseconds Standard Deviation 48.7

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Score (Words) at Baseline

15.4 Number of correct trials Standard Deviation 5.1

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Score (Words) at Week 7

16.0 Number of correct trials Standard Deviation 4.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors (Words) at Baseline

0.2 Number of incorrect trials Standard Deviation 0.8

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors (Words) at Week 7

0.4 Number of incorrect trials Standard Deviation 1.2

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time (Words) at Baseline

1434.5 milliseconds Standard Deviation 961.6

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time (Words) at Week 7

1248.4 milliseconds Standard Deviation 315.2

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Score (Colors) at Baseline

12.8 Number of correct trials Standard Deviation 4.2

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Score (Colors) at Week 7

15.7 Number of correct trials Standard Deviation 4.9

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors (Colors) at Baseline

0.3 Number of incorrect trials Standard Deviation 0.8

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors (Colors) at Week 7

2.1 Number of incorrect trials Standard Deviation 7.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time (Colors) at Baseline

1526.8 milliseconds Standard Deviation 399.2

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time (Colors) at Week 7

1176.2 milliseconds Standard Deviation 263.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Executive Function - Trials Completed at Baseline

9.5 Number of trials completed Standard Deviation 4.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Executive Function - Trials Completed at Week 7

8.1 Number of trials completed Standard Deviation 3.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Executive Function - Completion Time at Baseline

234774.9 milliseconds Standard Deviation 87879.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Executive Function - Completion Time at Week 7

174054.1 milliseconds Standard Deviation 93675.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Executive Function - Path Learning Time at Baseline

204859.7 milliseconds Standard Deviation 81156.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Executive Function - Path Learning Time at Week 7

148589.5 milliseconds Standard Deviation 88469.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Executive Function - Total Errors at Baseline

37.1 Number of incorrect moves Standard Deviation 27.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Executive Function - Total Errors at Week 7

26.3 Number of incorrect moves Standard Deviation 13.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Executive Function - Number of Overruns at Baseline

14.8 Number of incorrect moves Standard Deviation 14.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Executive Function - Number of Overruns at Week 7

12.8 Number of incorrect moves Standard Deviation 7.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Impulsivity - Reaction Time at Baseline

308.2 milliseconds Standard Deviation 63.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Impulsivity - Reaction Time at Week 7

307.8 milliseconds Standard Deviation 48.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Impulsivity - False Alarms at Baseline

6.1 Number of spacebar presses Standard Deviation 3.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Impulsivity - False Alarms at Week 7

5.2 Number of spacebar presses Standard Deviation 3.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Impulsivity - False Misses at Baseline

1.9 Number of spacebar presses Standard Deviation 2.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Placebo, Then Mydayis n=18 Participants 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.

WebNeuro Neurocognitive Assessment - Impulsivity - False Misses at Week 7

0.3 Number of spacebar presses Standard Deviation 0.6

Adverse Events

Placebo, Then Mydayis

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo, Then Mydayis n=18 participants at risk 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.
Nervous system disorders Headache	27.8% 5/18 • 7 Weeks Participants monitored weekly for abnormal vital signs, adverse events, and concomitant medications.
General disorders Pain - Arm	5.6% 1/18 • 7 Weeks Participants monitored weekly for abnormal vital signs, adverse events, and concomitant medications.
Gastrointestinal disorders Dry Mouth	16.7% 3/18 • 7 Weeks Participants monitored weekly for abnormal vital signs, adverse events, and concomitant medications.
Musculoskeletal and connective tissue disorders Back Pain	5.6% 1/18 • 7 Weeks Participants monitored weekly for abnormal vital signs, adverse events, and concomitant medications.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.6% 1/18 • 7 Weeks Participants monitored weekly for abnormal vital signs, adverse events, and concomitant medications.
Immune system disorders Allergic Reaction	5.6% 1/18 • 7 Weeks Participants monitored weekly for abnormal vital signs, adverse events, and concomitant medications.
Psychiatric disorders Insomnia	11.1% 2/18 • 7 Weeks Participants monitored weekly for abnormal vital signs, adverse events, and concomitant medications.
Injury, poisoning and procedural complications Burn	5.6% 1/18 • 7 Weeks Participants monitored weekly for abnormal vital signs, adverse events, and concomitant medications.
Respiratory, thoracic and mediastinal disorders Cough	11.1% 2/18 • 7 Weeks Participants monitored weekly for abnormal vital signs, adverse events, and concomitant medications.
Cardiac disorders Tachycardia	22.2% 4/18 • 7 Weeks Participants monitored weekly for abnormal vital signs, adverse events, and concomitant medications.
Metabolism and nutrition disorders Anorexia	5.6% 1/18 • 7 Weeks Participants monitored weekly for abnormal vital signs, adverse events, and concomitant medications.
General disorders COVID-19	5.6% 1/18 • 7 Weeks Participants monitored weekly for abnormal vital signs, adverse events, and concomitant medications.
General disorders Chills	5.6% 1/18 • 7 Weeks Participants monitored weekly for abnormal vital signs, adverse events, and concomitant medications.
General disorders Fatigue	5.6% 1/18 • 7 Weeks Participants monitored weekly for abnormal vital signs, adverse events, and concomitant medications.
Reproductive system and breast disorders Erectile Dysfunction	11.1% 2/18 • 7 Weeks Participants monitored weekly for abnormal vital signs, adverse events, and concomitant medications.
Metabolism and nutrition disorders Other - Increased Appetite	5.6% 1/18 • 7 Weeks Participants monitored weekly for abnormal vital signs, adverse events, and concomitant medications.
Nervous system disorders Dizziness	5.6% 1/18 • 7 Weeks Participants monitored weekly for abnormal vital signs, adverse events, and concomitant medications.
Respiratory, thoracic and mediastinal disorders Sore throat	5.6% 1/18 • 7 Weeks Participants monitored weekly for abnormal vital signs, adverse events, and concomitant medications.
General disorders Pain - Foot	5.6% 1/18 • 7 Weeks Participants monitored weekly for abnormal vital signs, adverse events, and concomitant medications.
Psychiatric disorders Agitation	5.6% 1/18 • 7 Weeks Participants monitored weekly for abnormal vital signs, adverse events, and concomitant medications.
Nervous system disorders Concentration impairment	5.6% 1/18 • 7 Weeks Participants monitored weekly for abnormal vital signs, adverse events, and concomitant medications.

Additional Information

Terry Leon

NYU Langone Health

Phone: 646 754 4837

Email: terry.leon@nyulangone.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place