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

NCT ID: NCT03945175

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-15
• Study Completion Date: 2022-05-11

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.

Conditions

Attention Deficit-Hyperactivity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

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

Group Type: EXPERIMENTAL

MYDAYIS

Intervention Type: 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.

Placebo

Intervention Type: DRUG

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

Interventions

MYDAYIS

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.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lenard Adler, MD

Role: PRINCIPAL_INVESTIGATOR

New York Langone Medical Center

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

19-00046

Identifier Type: -

Identifier Source: org_study_id