Recruiting

Jornay PM

Sponsor:

NYU Langone Health

Code:

NCT06577779

Conditions

Attention-deficit/Hyperactivity Disorder

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Methylphenidate Hydrochloride Extended Release Capsule

Study Details

Brief 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.

Conditions

Attention-deficit/Hyperactivity Disorder

Study ID

NCT06577779

Start date

Jan 29, 2025

Status verified date

Apr, 2026

Completion date

Oct 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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 Mental Disorders (DSM) -5 diagnosis of ADHD of predominantly inattentive presentation, or combined 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 an DSM AISRS 18 item total score of ≥ 28 at screening. Subjects who were previously receiving pharmacological treatment for ADHD at screening must have a minimum total DSM AISRS 18 item score of ≥ 22 at screening
6. Dysthymia and anxiety disorders in remission, but stable on psychiatric medication for 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 during screening process until subject is enrolled into the study. After subject is enrolled onto Jornay PM, subject is asked to complete an attestation. The attestation will state that the subject will not consume marijuana while in the study.
9. No illicit substance will be allowed at screening or during the study.

Exclusion Criteria:

1. Known hypersensitivity to methylphenidate, or product components.
2. Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days.
3. Lifetime bipolar disorder, psychotic disorders, autism, intellectual disability except mood disorders accepted under the inclusion criteria at the discretion of the principal 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 International Neuropsychiatric Interview (MINI) (i.e., a focus of clinical attention or a cause of substantial social or occupational difficulty)
6. Concurrent substance abuse and/or history of substance use within 6 months (except for marijuana use of less than three times a week and/or history of excessive marijuana 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 medical abnormalities such as cardiovascular abnormalities, and any chronic condition of the central nervous system
9. Antidepressants and anti-anxiety agents (including benzodiazepines) taken in stable doses will be allowed, while other psychotropic medications, including hallucinogens, 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 pregnant or men planning to make a woman pregnant during the study or for one-month post study
13. PI/clinician discretion

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Seven weeks of Jornay PM treatment

Enrolled participants will begin with a two-week observation stabilization before starting treatment with Jornay PM. Participants found to have ≥30% change in their total Adult ADHD Investigator Symptom Rating Scale (AISRS) scores during the two-week observation stabilization period treatment will be discontinued from the study. Remaining participants will initiate a 7 week open-label treatment with Jornay PM.

experimental: Five weeks of Jornay PM treatment

Enrolled participants will begin with a two-week observation stabilization before starting treatment with Jornay PM. Participants found to have ≥30% change in their total Adult ADHD Investigator Symptom Rating Scale (AISRS) scores during the two-week observation stabilization period treatment will be discontinued from the study. Remaining participants will initiate a 5 week open-label treatment with Jornay PM followed by a two week observation period; not receiving Jornay PM.

Interventions

Methylphenidate Hydrochloride Extended Release Capsule

Subjects will start at dose of 40mg (DR/ER-MPH) day with titrations of 20mg leading to a maximum dose of 100mg (DR/ER-MPH).

Primary outcome measure

  • Change in Expanded Adult ADHD Investigator Symptom Rating Scale (AISRS) Score from Baseline to Week 3 [ Time Frame: Baseline, Week 3 ]
  • Change in Expanded Adult ADHD Investigator Symptom Rating Scale (AISRS) Score from Baseline to Week 10 [ Time Frame: Baseline, Week 10 ]

Central Contacts and Locations

Central contacts

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Keywords

  • ADHD
  • Adult ADHD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-04-29.