Trial · NCT03945175
Study of the Duration and Efficacy of MYDAYIS on Adult ADHD Symptoms and Executive Function Throughout the Day Into the Early Evening
NCT03945175, Phase 3, Completed, NYU Langone Health; results first posted 2023-06-29
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study of the Duration and Efficacy of MYDAYIS on Adult ADHD Symptoms and Executive Function Throughout the Day Into the Early Evening. Trials, record NCT03945175. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03945175
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the Duration and Efficacy of MYDAYIS on Adult ADHD Symptoms and Executive Function Throughout the Day Into the Early Evening
- NCT number
- NCT03945175
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 52 participants, actual
- Lead sponsor
- NYU Langone Health
- Conditions
- Attention Deficit-Hyperactivity
- Interventions
- MYDAYIS, Placebo
- First posted
- 2019-05-10
- Last updated
- 2024-03-08
- Results first posted
- 2023-06-29
Source ClinicalTrials.gov
Registered outcomes66
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adult ADHD Investigator Symptom Rating Scale (AISRS) Score at End of Placebo Lead-In | Week 2 (End of Placebo Lead-In) | 18-item questionnaire measuring aspects of ADHD in adults. Participants rank items on a 4-point Likert scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of ADHD. |
| Primary | Adult ADHD Investigator Symptom Rating Scale (AISRS) Score at End of Mydayis Treatment | Week 6 (End of Mydayis Treatment) | 18-item questionnaire measuring aspects of ADHD in adults. Participants rank items on a 4-point Likert scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of ADHD. |
| Secondary | AISRS: Overall Inattentive (IA) Symptom Subscale Score at End of Placebo Lead-In | Week 2 (End of Placebo Lead-In) | The IA symptom subscale comprises 9 items of the AISRS measuring inattentive symptoms of ADHD. Items are ranked on a 4-point Likert scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The total IA subscale score ranges from 0 to 27; higher scores indicate more severe IA symptoms. |
| Secondary | AISRS: Overall Inattentive (IA) Symptom Subscale Score at End of Mydayis Treatment | Week 6 (End of Mydayis Treatment) | The IA symptom subscale comprises 9 items of the AISRS measuring inattentive symptoms of ADHD. Items are ranked on a 4-point Likert scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The total IA subscale score ranges from 0 to 27; higher scores indicate more severe IA symptoms. |
| Secondary | AISRS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Placebo Lead-In | Week 2 (End of Placebo Lead-In) | The HI symptom subscale comprises 9 items of the AISRS measuring hyperactive-impulsive symptoms of ADHD. Items are ranked on a 4-point Likert scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The total IA subscale score ranges from 0 to 27; higher scores indicate more severe HI symptoms. |
| Secondary | AISRS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Mydayis Treatment | Week 6 (End of Mydayis Treatment) | The HI symptom subscale comprises 9 items of the AISRS measuring hyperactive-impulsive symptoms of ADHD. Items are ranked on a 4-point Likert scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The total IA subscale score ranges from 0 to 27; higher scores indicate more severe HI symptoms. |
| Secondary | Clinical Global Impression-Severity (CGI-S) Scale Score at End of Placebo Lead-In | Week 2 (End of Placebo Lead-In) | 7-item questionnaire requiring a clinician to rate the severity of a patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. The ratings range from 1-7, where: 1 = Normal, not at all ill; 2 = Borderline mentally ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; and 7 = Among the most extremely ill patients. |
| Secondary | Clinical Global Impression-Severity (CGI-S) Scale Score at End of Mydayis Treatment | Week 6 (End of Mydayis Treatment) | 7-item questionnaire requiring a clinician to rate the severity of a patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. The ratings range from 1-7, where: 1 = Normal, not at all ill; 2 = Borderline mentally ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; and 7 = Among the most extremely ill patients. |
| Secondary | 14-Hour Post-Dose Time-Sensitive Adult ADHD Symptom Scale (TASS) Score at End of Placebo Lead-In | Week 2 (End of Placebo Lead-In) | 18-item assessment of the severity of ADHD symptoms administered 14 hours after morning dosing. Items are ranked on a 4-point Likert scale: 0 (not at all), 1 (mild), 2 (moderate), 3 (severe). The total score is the sum of all the items on the scale and ranges from 0 to 54. A higher total score indicates more severe ADHD. |
| Secondary | 14-Hour Post-Dose Time-Sensitive Adult ADHD Symptom Scale (TASS) Score at End of Mydayis Treatment | Week 6 (End of Mydayis Treatment) | 18-item assessment of the severity of ADHD symptoms administered 14 hours after morning dosing. Items are ranked on a 4-point Likert scale: 0 (not at all), 1 (mild), 2 (moderate), 3 (severe). The total score is the sum of all the items on the scale and ranges from 0 to 54. A higher total score indicates more severe ADHD. |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 registered outcomesOutcomes66
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Adult ADHD Investigator Symptom Rating Scale (AISRS) Score at End of Placebo Lead-In | Week 2 (End of Placebo Lead-In) | score on a scale | MEAN | |
| PRIMARY | Adult ADHD Investigator Symptom Rating Scale (AISRS) Score at End of Mydayis Treatment | Week 6 (End of Mydayis Treatment) | score on a scale | MEAN | |
| SECONDARY | AISRS: Overall Inattentive (IA) Symptom Subscale Score at End of Placebo Lead-In | Week 2 (End of Placebo Lead-In) | score on a scale | MEAN | |
| SECONDARY | AISRS: Overall Inattentive (IA) Symptom Subscale Score at End of Mydayis Treatment | Week 6 (End of Mydayis Treatment) | score on a scale | MEAN | |
| SECONDARY | AISRS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Placebo Lead-In | Week 2 (End of Placebo Lead-In) | score on a scale | MEAN | |
| SECONDARY | AISRS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Mydayis Treatment | Week 6 (End of Mydayis Treatment) | score on a scale | MEAN | |
| SECONDARY | Clinical Global Impression-Severity (CGI-S) Scale Score at End of Placebo Lead-In | Week 2 (End of Placebo Lead-In) | score on a scale | MEAN | |
| SECONDARY | Clinical Global Impression-Severity (CGI-S) Scale Score at End of Mydayis Treatment | Week 6 (End of Mydayis Treatment) | score on a scale | MEAN | |
| SECONDARY | 14-Hour Post-Dose Time-Sensitive Adult ADHD Symptom Scale (TASS) Score at End of Placebo Lead-In | Week 2 (End of Placebo Lead-In) | score on a scale | MEAN | |
| SECONDARY | 14-Hour Post-Dose Time-Sensitive Adult ADHD Symptom Scale (TASS) Score at End of Mydayis Treatment | Week 6 (End of Mydayis Treatment) | score on a scale | MEAN |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 outcomesResults by group66
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Adult ADHD Investigator Symptom Rating Scale (AISRS) Score at End of Placebo Lead-In | Placebo, Then Mydayis | 37.2 | Standard Deviation 11.4 | score on a scale | |
| Adult ADHD Investigator Symptom Rating Scale (AISRS) Score at End of Mydayis Treatment | Placebo, Then Mydayis | 18.5 | Standard Deviation 8.9 | score on a scale | |
| AISRS: Overall Inattentive (IA) Symptom Subscale Score at End of Placebo Lead-In | Placebo, Then Mydayis | 19.9 | Standard Deviation 6.1 | score on a scale | |
| AISRS: Overall Inattentive (IA) Symptom Subscale Score at End of Mydayis Treatment | Placebo, Then Mydayis | 9.6 | Standard Deviation 4.7 | score on a scale | |
| AISRS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Placebo Lead-In | Placebo, Then Mydayis | 17.3 | Standard Deviation 5.8 | score on a scale | |
| AISRS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Mydayis Treatment | Placebo, Then Mydayis | 8.8 | Standard Deviation 5.0 | score on a scale | |
| Clinical Global Impression-Severity (CGI-S) Scale Score at End of Placebo Lead-In | Placebo, Then Mydayis | 4.6 | Standard Deviation 0.8 | score on a scale | |
| Clinical Global Impression-Severity (CGI-S) Scale Score at End of Mydayis Treatment | Placebo, Then Mydayis | 3.1 | Standard Deviation 1.0 | score on a scale | |
| 14-Hour Post-Dose Time-Sensitive Adult ADHD Symptom Scale (TASS) Score at End of Placebo Lead-In | Placebo, Then Mydayis | 24.6 | Standard Deviation 10.8 | score on a scale | |
| 14-Hour Post-Dose Time-Sensitive Adult ADHD Symptom Scale (TASS) Score at End of Mydayis Treatment | Placebo, Then Mydayis | 16.8 | Standard Deviation 10.8 | score on a scale |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo, Then Mydayis | 52 | |
| Overall Study | Participants Who Met Inclusion Criteria | Placebo, Then Mydayis | 21 | |
| Overall Study | Participants Allocated to Single-Blind Placebo Treatment | Placebo, Then Mydayis | 21 | |
| Overall Study | Participants Who Completed Single-Blind Placebo Treatment | Placebo, Then Mydayis | 20 | |
| Overall Study | Participants Allocated to Mydayis Treatment | Placebo, Then Mydayis | 18 | |
| Overall Study | Participants Included in Analysis of Outcome Measures | Placebo, Then Mydayis | 18 | |
| Overall Study | COMPLETED | Placebo, Then Mydayis | 17 | |
| Overall Study | NOT COMPLETED | Placebo, Then Mydayis | 35 |
Source ClinicalTrials.gov
Adverse events21
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Placebo, Then Mydayis | 5 | 18 | |
| other | Pain - Arm | General disorders | Placebo, Then Mydayis | 1 | 18 | |
| other | Dry Mouth | Gastrointestinal disorders | Placebo, Then Mydayis | 3 | 18 | |
| other | Back Pain | Musculoskeletal and connective tissue disorders | Placebo, Then Mydayis | 1 | 18 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Placebo, Then Mydayis | 1 | 18 | |
| other | Allergic Reaction | Immune system disorders | Placebo, Then Mydayis | 1 | 18 | |
| other | Insomnia | Psychiatric disorders | Placebo, Then Mydayis | 2 | 18 | |
| other | Burn | Injury, poisoning and procedural complications | Placebo, Then Mydayis | 1 | 18 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Placebo, Then Mydayis | 2 | 18 | |
| other | Tachycardia | Cardiac disorders | Placebo, Then Mydayis | 4 | 18 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo, Then Mydayis | 0 | 18 |
| Total, other adverse events | Placebo, Then Mydayis | 14 | 18 |
| Total, serious adverse events | Placebo, Then Mydayis | 0 | 18 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Choice Reaction Time | Secondary outcome | ConductCognition |
| Continuous Performance Test | Secondary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Go/No-Go Task | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03945175
GET https://conductscience.org/api/trials/v1/NCT03945175/registered?page=2