Clinical trial NCT03945175: Study of the Duration and Efficacy of MYDAYIS on Adult ADHD Symptoms and Executive Function Throughout the Day Into the Early Evening
Official title: Study of the Duration and Efficacy of MYDAYIS on Adult ADHD Symptoms and Executive Function Throughout the Day Into the Early Evening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit-Hyperactivity
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-05-10
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: One purpose of this trial is to extend the evidence basis for Mydayis in adult ADHD to include efficacy with a clinical ADHD symptom measure validated for DSM-5 adult ADHD. Another purpose of this trial is to re-examine the clinical efficacy of Mydayis later in the day on ADHD symptoms; the data on ADHD symptoms via the TASS 1 (Spencer et al. 2008) is a decade old and has not been examined in subsequent trials.

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.

Primary outcomes:
measure: Adult ADHD Investigator Symptom Rating Scale (AISRS) Score at End of Placebo Lead-In
timeFrame: Week 2 (End of Placebo Lead-In)
measure: Adult ADHD Investigator Symptom Rating Scale (AISRS) Score at End of Mydayis Treatment
timeFrame: Week 6 (End of Mydayis Treatment)
Secondary outcomes:
measure: AISRS: Overall Inattentive (IA) Symptom Subscale Score at End of Placebo Lead-In
timeFrame: Week 2 (End of Placebo Lead-In)
measure: AISRS: Overall Inattentive (IA) Symptom Subscale Score at End of Mydayis Treatment
timeFrame: Week 6 (End of Mydayis Treatment)
measure: AISRS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Placebo Lead-In
timeFrame: Week 2 (End of Placebo Lead-In)
measure: AISRS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Mydayis Treatment
timeFrame: Week 6 (End of Mydayis Treatment)
measure: Clinical Global Impression-Severity (CGI-S) Scale Score at End of Placebo Lead-In
timeFrame: Week 2 (End of Placebo Lead-In)
measure: Clinical Global Impression-Severity (CGI-S) Scale Score at End of Mydayis Treatment
timeFrame: Week 6 (End of Mydayis Treatment)
measure: 14-Hour Post-Dose Time-Sensitive Adult ADHD Symptom Scale (TASS) Score at End of Placebo Lead-In
timeFrame: Week 2 (End of Placebo Lead-In)
measure: 14-Hour Post-Dose Time-Sensitive Adult ADHD Symptom Scale (TASS) Score at End of Mydayis Treatment
timeFrame: Week 6 (End of Mydayis Treatment)
measure: 14-hour Post-Dose TASS: Inattentive (IA) Symptom Subscale Score at End of Placebo Lead-In
timeFrame: Week 2 (End of Placebo Lead-In)
measure: 14-hour Post-Dose TASS: Inattentive (IA) Symptom Subscale Score at End of Mydayis Treatment
timeFrame: Week 6 (End of Mydayis Treatment)
measure: 14-hour Post-Dose TASS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Placebo Lead-In
timeFrame: Week 2 (End of Placebo Lead-In)
measure: 14-hour Post-Dose TASS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Mydayis Treatment
timeFrame: Week 6 (End of Mydayis Treatment)
measure: Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Score at Week 3
timeFrame: Week 3
measure: Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Score at Week 7
timeFrame: Week 7
measure: WebNeuro Neurocognitive Assessment - Working Memory Capacity - Recall Span Score at Baseline
timeFrame: Baseline
measure: WebNeuro Neurocognitive Assessment - Working Memory Capacity - Recall Span Score at Week 7
timeFrame: Week 7
measure: WebNeuro Neurocognitive Assessment - Working Memory Capacity - Working Memory Accuracy at Baseline
timeFrame: Baseline
measure: WebNeuro Neurocognitive Assessment - Working Memory Capacity - Working Memory Accuracy at Week 7
timeFrame: Week 7
measure: WebNeuro Neurocognitive Assessment - Attention and Concentration - Reaction Time at Baseline
timeFrame: Baseline
measure: WebNeuro Neurocognitive Assessment - Attention and Concentration - Reaction Time at Week 7
timeFrame: Week 7
measure: WebNeuro Neurocognitive Assessment - Attention and Concentration - False Alarms at Baseline
timeFrame: Baseline
measure: WebNeuro Neurocognitive Assessment - Attention and Concentration - False Alarms at Week 7
timeFrame: Week 7
measure: WebNeuro Neurocognitive Assessment - Attention and Concentration - False Misses at Baseline
timeFrame: Baseline
measure: WebNeuro Neurocognitive Assessment - Attention and Concentration - False Misses at Week 7
timeFrame: Week 7
measure: WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Completion Time at Baseline
timeFrame: Baseline
measure: WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Completion Time at Week 7
timeFrame: Week 7
measure: WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Average Connection Time at Baseline
timeFrame: Baseline
measure: WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Average Connection Time at Week 7
timeFrame: Week 7
measure: WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors at Baseline
timeFrame: Baseline
measure: WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors at Week 7
timeFrame: Week 7
measure: WebNeuro Neurocognitive Assessment - Response Speed - Number of Taps at Baseline
timeFrame: Baseline
measure: WebNeuro Neurocognitive Assessment - Response Speed - Number of Taps at Week 7
timeFrame: Week 7
measure: WebNeuro Neurocognitive Assessment - Response Speed - Tapping Variability at Baseline
timeFrame: Baseline
measure: WebNeuro Neurocognitive Assessment - Response Speed - Tapping Variability at Week 7
timeFrame: Week 7
measure: WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time at Baseline
timeFrame: Baseline
measure: WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time at Week 7
timeFrame: Week 7
measure: WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Score (Words) at Baseline
timeFrame: Baseline
measure: WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Score (Words) at Week 7
timeFrame: Week 7
measure: WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors (Words) at Baseline
timeFrame: Baseline
measure: WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors (Words) at Week 7
timeFrame: Week 7
measure: WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time (Words) at Baseline
timeFrame: Baseline
measure: WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time (Words) at Week 7
timeFrame: Week 7
measure: WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Score (Colors) at Baseline
timeFrame: Baseline
measure: WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Score (Colors) at Week 7
timeFrame: Week 7
measure: WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors (Colors) at Baseline
timeFrame: Baseline
measure: WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors (Colors) at Week 7
timeFrame: Week 7
measure: WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time (Colors) at Baseline
timeFrame: Baseline
measure: WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time (Colors) at Week 7
timeFrame: Week 7
measure: WebNeuro Neurocognitive Assessment - Executive Function - Trials Completed at Baseline
timeFrame: Baseline
measure: WebNeuro Neurocognitive Assessment - Executive Function - Trials Completed at Week 7
timeFrame: Week 7
measure: WebNeuro Neurocognitive Assessment - Executive Function - Completion Time at Baseline
timeFrame: Baseline
measure: WebNeuro Neurocognitive Assessment - Executive Function - Completion Time at Week 7
timeFrame: Week 7
measure: WebNeuro Neurocognitive Assessment - Executive Function - Path Learning Time at Baseline
timeFrame: Baseline
measure: WebNeuro Neurocognitive Assessment - Executive Function - Path Learning Time at Week 7
timeFrame: Week 7
measure: WebNeuro Neurocognitive Assessment - Executive Function - Total Errors at Baseline
timeFrame: Baseline
measure: WebNeuro Neurocognitive Assessment - Executive Function - Total Errors at Week 7
timeFrame: Week 7
measure: WebNeuro Neurocognitive Assessment - Executive Function - Number of Overruns at Baseline
timeFrame: Baseline
measure: WebNeuro Neurocognitive Assessment - Executive Function - Number of Overruns at Week 7
timeFrame: Week 7
measure: WebNeuro Neurocognitive Assessment - Impulsivity - Reaction Time at Baseline
timeFrame: Baseline
measure: WebNeuro Neurocognitive Assessment - Impulsivity - Reaction Time at Week 7
timeFrame: Week 7
measure: WebNeuro Neurocognitive Assessment - Impulsivity - False Alarms at Baseline
timeFrame: Baseline
measure: WebNeuro Neurocognitive Assessment - Impulsivity - False Alarms at Week 7
timeFrame: Week 7
measure: WebNeuro Neurocognitive Assessment - Impulsivity - False Misses at Baseline
timeFrame: Week 7
measure: WebNeuro Neurocognitive Assessment - Impulsivity - False Misses at Week 7
timeFrame: Week 7
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York Langone Medical Center
name: Lenard Adler, MD
role: PRINCIPAL_INVESTIGATOR
References: