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

NCT03945175 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 19-00046
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit-Hyperactivity

Outcome Measures

Primary Outcomes (2)

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

  18-item questionnaire measuring aspects of ADHD in adults. Participants rank items on a 4-point Likert scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of ADHD.

  Week 2 (End of Placebo Lead-In)

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

  18-item questionnaire measuring aspects of ADHD in adults. Participants rank items on a 4-point Likert scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of ADHD.

  Week 6 (End of Mydayis Treatment)

Secondary Outcomes (64)

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

  Week 2 (End of Placebo Lead-In)

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

  Week 6 (End of Mydayis Treatment)

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

  Week 2 (End of Placebo Lead-In)

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

  Week 6 (End of Mydayis Treatment)

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

  Week 2 (End of Placebo Lead-In)

Study Arms (1)

Treatment

EXPERIMENTAL

After a two-week, single-blinded, placebo lead-in, all patients will receive four weeks of order-fixed treatment with Mydayis.

Drug: MYDAYIS; Drug: Placebo

Interventions

MYDAYIS DRUG

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.

Treatment

Placebo DRUG

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

Treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Results Point of Contact

• Title: Terry Leon
• Organization: NYU Langone Health

terry.leon@nyulangone.org

646 754 4837

Study Officials

• Lenard Adler, MD

  New York Langone Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 10, 2019
• Study Start: July 15, 2020
• Primary Completion: May 11, 2022
• Study Completion: May 11, 2022
• Last Updated: March 8, 2024
• Results First Posted: June 29, 2023

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data.

Locations

US (1)