New York, New York 10016

  • Hyperactivity

Purpose:

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.


Study summary:

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.


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.


NCT ID:

NCT03945175


Primary Contact:

Principal Investigator
Leonard Adler, MD
New York Langone Medical Center

Terry Leon
Phone: 646 754 4837
Email: terry.leon@nyulangone.org


Backup Contact:

N/A


Location Contact:

New York, New York 10016
United States

Terry Leon
Phone: 646-754-4837
Email: terry.leon@nyulangone.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 02, 2021

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