An Open-Label Treatment With Randomization Observation, Investigator-Initiated Study, on the Duration and Efficacy of Jornay PM (Methylphenidate Hydrochloride Extended-Release Capsules) on Adult ADHD Symptoms and Executive Function and Emotional Regulation Throughout the Day Into Early Evening

Last updated: August 28, 2024
Sponsor: NYU Langone Health
Overall Status: Active - Recruiting

Phase

4

Condition

Attention Deficit/hyperactivity Disorder (Adhd - Adults)

Williams Syndrome

Treatment

Methylphenidate Hydrochloride Extended Release Capsule

Clinical Study ID

NCT06577779
19-01325
  • Ages 18-60
  • All Genders

Study Summary

The goal of this study is to extend the efficacy evidence of sustained release methylphenidate compound (JornayPM) in adults with Attention-deficit/hyperactivity disorder (ADHD). JornayPM has recently been approved for treatment of patients 6 years and older with ADHD; the release mechanism is unique among ADHD products in that it is taken in the evening, with effects in the morning upon awakening and then throughout the subsequent day. Of note, to date, there is no clinical data as to the tolerability or clinical effects or dosing in adults with ADHD; therefore the primary aim of this trial is to gather the first set of these data.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adults ages 18-60 years, inclusive at the time of consent

  2. Able to provide signed informed consent

  3. Any gender

  4. Subjects with a current primary Diagnostic and Statistical Manual of MentalDisorders (DSM) -5 diagnosis of ADHD of predominantly inattentive presentation, orcombined presentations) as confirmed by the Adult ADHD Clinical Diagnostic Scale (ACDS) Version 1.2.

  5. Subjects who are not receiving any pharmacological treatment for ADHD must have anDSM AISRS 18 item total score of ≥ 28 at screening. Subjects who were previouslyreceiving pharmacological treatment for ADHD at screening must have a minimum totalDSM AISRS 18 item score of ≥ 22 at screening

  6. Dysthymia and anxiety disorders in remission, but stable on psychiatric medicationfor three weeks or more at the discretion of principal investigator will be allowed.Medication for these disorders to remain constant for the duration of the protocol.

  7. Subjects, who have not used stimulant medication in the past 2 months.

  8. Occasional use of marijuana (less than 3 times weekly) will be allowed duringscreening process until subject is enrolled into the study. After subject isenrolled onto Jornay PM, subject is asked to complete an attestation. Theattestation will state that the subject will not consume marijuana while in thestudy.

  9. No illicit substance will be allowed at screening or during the study.

Exclusion

Exclusion Criteria:

  1. Known hypersensitivity to methylphenidate, or product components.

  2. Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOIwithin the preceding 14 days.

  3. Lifetime bipolar disorder, psychotic disorders, autism, intellectual disabilityexcept mood disorders accepted under the inclusion criteria at the discretion of theprincipal investigator.

  4. Active suicidality within past year, or history of suicide attempt in past 2 years

  5. Any history of severe past drug dependence determined by the Mini InternationalNeuropsychiatric Interview (MINI) (i.e., a focus of clinical attention or a cause ofsubstantial social or occupational difficulty)

  6. Concurrent substance abuse and/or history of substance use within 6 months (exceptfor marijuana use of less than three times a week and/or history of excessivemarijuana use of less than three times a week within 6 months).

  7. Use of any prescribed benzodiazepine

  8. Any unstable medical or neurological condition; clinically significant medicalabnormalities such as cardiovascular abnormalities, and any chronic condition of thecentral nervous system

  9. Antidepressants and anti-anxiety agents (including benzodiazepines) taken in stabledoses will be allowed, while other psychotropic medications, includinghallucinogens, mood stabilizers, antipsychotics will not be allowed

  10. Known nonresponse to MPH treatment

  11. History of allergic reaction or sensitivity to MPH

  12. Female of childbearing age, who are breastfeeding, pregnant, planning to be pregnantor men planning to make a woman pregnant during the study or for one-month poststudy

  13. PI/clinician discretion

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Methylphenidate Hydrochloride Extended Release Capsule
Phase: 4
Study Start date:
August 19, 2024
Estimated Completion Date:
October 31, 2025

Connect with a study center

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

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