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

Last updated: March 6, 2024
Sponsor: NYU Langone Health
Overall Status: Completed

Phase

3

Condition

Williams Syndrome

Attention Deficit/hyperactivity Disorder (Adhd - Adults)

Treatment

MYDAYIS

Placebo

Clinical Study ID

NCT03945175
19-00046
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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 predominantlyinattentive presentation, or combined presentation) as diagnosed via the Adult ADHDClinician Diagnostic Scale version 1.2 (ACDS v1.2)

Exclusion

Exclusion Criteria:

  • Meets DSM V-TR criteria for a primary diagnosis of hyperactive-impulsive type ADHD asdiagnosed via the ACDS v1.2.
  • Any other current psychiatric disorder, determined via the M.I.N.I, which requirespharmacotherapy 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 fromparticipating in the study or compromise the subject safety.

Study Design

Total Participants: 52
Treatment Group(s): 2
Primary Treatment: MYDAYIS
Phase: 3
Study Start date:
July 15, 2020
Estimated Completion Date:
May 11, 2022

Study 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.

Connect with a study center

  • New York University School of Medicine

    New York, New York 10016
    United States

    Site Not Available

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