Phase 3
N=52
Study of the Duration and Efficacy of MYDAYIS on Adult ADHD Symptoms and Executive Function Throughout the Day Into the Early Evening
Attention Deficit-Hyperactivity
Bottom Line
View on ClinicalTrials.gov: NCT03945175 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Adult ADHD Investigator Symptom Rating Scale (AISRS) Score at End of Placebo Lead-In — 37.2 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MYDAYIS (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adult ADHD Investigator Symptom Rating Scale (AISRS) Score at End of Placebo Lead-In |
37.2 | — |
| PRIMARY Adult ADHD Investigator Symptom Rating Scale (AISRS) Score at End of Mydayis Treatment |
18.5 | — |
| SECONDARY AISRS: Overall Inattentive (IA) Symptom Subscale Score at End of Placebo Lead-In |
19.9 | — |
| SECONDARY AISRS: Overall Inattentive (IA) Symptom Subscale Score at End of Mydayis Treatment |
9.6 | — |
| SECONDARY AISRS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Placebo Lead-In |
17.3 | — |
| SECONDARY AISRS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Mydayis Treatment |
8.8 | — |
| SECONDARY Clinical Global Impression-Severity (CGI-S) Scale Score at End of Placebo Lead-In |
4.6 | — |
| SECONDARY Clinical Global Impression-Severity (CGI-S) Scale Score at End of Mydayis Treatment |
3.1 | — |
| SECONDARY 14-Hour Post-Dose Time-Sensitive Adult ADHD Symptom Scale (TASS) Score at End of Placebo Lead-In |
24.6 | — |
| SECONDARY 14-Hour Post-Dose Time-Sensitive Adult ADHD Symptom Scale (TASS) Score at End of Mydayis Treatment |
16.8 | — |
| SECONDARY 14-hour Post-Dose TASS: Inattentive (IA) Symptom Subscale Score at End of Placebo Lead-In |
15.4 | — |
| SECONDARY 14-hour Post-Dose TASS: Inattentive (IA) Symptom Subscale Score at End of Mydayis Treatment |
9.8 | — |
| SECONDARY 14-hour Post-Dose TASS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Placebo Lead-In |
9.2 | — |
| SECONDARY 14-hour Post-Dose TASS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Mydayis Treatment |
6.9 | — |
| SECONDARY Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Score at Week 3 |
68.6 | — |
| SECONDARY Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Score at Week 7 |
58.6 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Working Memory Capacity - Recall Span Score at Baseline |
5.8 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Working Memory Capacity - Recall Span Score at Week 7 |
6.4 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Working Memory Capacity - Working Memory Accuracy at Baseline |
6.9 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Working Memory Capacity - Working Memory Accuracy at Week 7 |
7.7 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Attention and Concentration - Reaction Time at Baseline |
567.0 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Attention and Concentration - Reaction Time at Week 7 |
566.3 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Attention and Concentration - False Alarms at Baseline |
1.3 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Attention and Concentration - False Alarms at Week 7 |
1.0 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Attention and Concentration - False Misses at Baseline |
0.7 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Attention and Concentration - False Misses at Week 7 |
0.7 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Completion Time at Baseline |
56771.9 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Completion Time at Week 7 |
47752.6 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Average Connection Time at Baseline |
2228.0 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Average Connection Time at Week 7 |
1863.1 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors at Baseline |
0.8 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors at Week 7 |
0.7 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Response Speed - Number of Taps at Baseline |
189.6 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Response Speed - Number of Taps at Week 7 |
189.9 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Response Speed - Tapping Variability at Baseline |
24.4 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Response Speed - Tapping Variability at Week 7 |
30.4 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time at Baseline |
379.2 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time at Week 7 |
378.2 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Score (Words) at Baseline |
15.4 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Score (Words) at Week 7 |
16.0 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors (Words) at Baseline |
0.2 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors (Words) at Week 7 |
0.4 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time (Words) at Baseline |
1434.5 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time (Words) at Week 7 |
1248.4 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Score (Colors) at Baseline |
12.8 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Score (Colors) at Week 7 |
15.7 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors (Colors) at Baseline |
0.3 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors (Colors) at Week 7 |
2.1 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time (Colors) at Baseline |
1526.8 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time (Colors) at Week 7 |
1176.2 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Executive Function - Trials Completed at Baseline |
9.5 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Executive Function - Trials Completed at Week 7 |
8.1 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Executive Function - Completion Time at Baseline |
234774.9 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Executive Function - Completion Time at Week 7 |
174054.1 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Executive Function - Path Learning Time at Baseline |
204859.7 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Executive Function - Path Learning Time at Week 7 |
148589.5 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Executive Function - Total Errors at Baseline |
37.1 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Executive Function - Total Errors at Week 7 |
26.3 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Executive Function - Number of Overruns at Baseline |
14.8 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Executive Function - Number of Overruns at Week 7 |
12.8 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Impulsivity - Reaction Time at Baseline |
308.2 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Impulsivity - Reaction Time at Week 7 |
307.8 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Impulsivity - False Alarms at Baseline |
6.1 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Impulsivity - False Alarms at Week 7 |
5.2 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Impulsivity - False Misses at Baseline |
1.9 | — |
| SECONDARY WebNeuro Neurocognitive Assessment - Impulsivity - False Misses at Week 7 |
0.3 | — |
Summary
Attention-deficit/hyperactivity disorder (ADHD) is a neuropsychiatric disorder characterized by problems with sustaining attention, organization, planning, procrastination, daydreaming, restlessness, impulsivity and hyperactivity.This is an outpatient study for subjects between the ages of 18-60, who have an Attention deficit hyperactivity disorder (ADHD) diagnosis meeting all inclusion criteria and not meeting any of the exclusion criteria.
Eligibility Criteria
Inclusion Criteria
- Male or female between the ages of 18-60 of all races and ethnicity.
- Meets DSM V-TR criteria for a primary diagnosis of ADHD (including predominantly inattentive presentation, or combined presentation) as diagnosed via the Adult ADHD Clinician Diagnostic Scale version 1.2 (ACDS v1.2)
Exclusion Criteria
- Meets DSM V-TR criteria for a primary diagnosis of hyperactive-impulsive type ADHD as diagnosed via the ACDS v1.2.
- Any other current psychiatric disorder, determined via the M.I.N.I, which requires pharmacotherapy treatment.
- Current suicidal ideation or history of suicide attempts, based on the Columbia- Suicide Severity Rating Scale(C-SSRS)
- Lifetime history of bipolar disorder or any psychotic disorder as per the M.I.N.I
- Pregnant, breastfeeding or women planning to become pregnant.
- Positive urine drug toxicology are excluded.
- Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety.
Data sourced from ClinicalTrials.gov (NCT03945175). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.