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

NYU Langone Health

Status and phase: Completed; Phase 3

Conditions: Attention Deficit-Hyperactivity

Treatments: Drug: MYDAYIS; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03945175

19-00046

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Treatment

Experimental group

Description:

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

Treatment:

Drug: MYDAYIS

Drug: Placebo