Treatment for adult ADHD using Jornay PM

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

This study is testing if taking Jornay PM, a new ADHD medication taken at night, can help adults manage their symptoms better during the day.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: NYU Langone Health (Academic / other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT06577779 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the efficacy and tolerability of Jornay PM, a sustained-release formulation of methylphenidate, in adults with Attention-deficit/Hyperactivity Disorder (ADHD). Participants will be randomized to receive the medication, which is uniquely taken in the evening to provide symptom relief throughout the following day. The study will gather important data on how this treatment affects ADHD symptoms, executive function, and emotional regulation in adults. This is the first clinical trial to assess the effects of Jornay PM specifically in the adult population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-60 with a confirmed diagnosis of ADHD, particularly those who are not currently on pharmacological treatment.

Not a fit: Patients with severe comorbid psychiatric disorders or those who have used stimulant medications recently may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve daily functioning and quality of life for adults with ADHD.

How similar studies have performed: While there is limited data on this specific formulation in adults, similar studies on ADHD treatments have shown promising results.

Eligibility criteria

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

Where this trial is running

New York, New York

• NYU Langone Health — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: Lenard Adler, MD — NYU Langone Health
• Study coordinator: Terry Leon, MS, RN

Conditions Attention-deficit/Hyperactivity Disorder; ADHD; Adult ADHD