Actively Recruiting
Study of Jornay PM (Methylphenidate Extended-Release Capsules) on Symptoms and Function in Adults With ADHD
Led by NYU Langone Health · Updated on 2026-04-29
30
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of a sustained-release methylphenidate compound called Jornay PM in adults aged 18 to 60 with Attention-deficit/hyperactivity disorder (ADHD). Jornay PM is unique because it is taken in the evening but works the next morning and throughout the day. Although it is approved for patients 6 years and older, this trial aims to collect the first data on how well adults tolerate this treatment and how it affects their ADHD symptoms and daily functioning. Participants will start with a two-week observation period to stabilize their symptoms without treatment. Those whose symptoms change significantly during this time will not continue. The remaining participants will begin open-label treatment with Jornay PM, either for seven weeks or for five weeks followed by two weeks without the medication. The medication dose starts at 40 mg and may be adjusted up to 100 mg during the study. Throughout the study, participants will have their ADHD symptoms evaluated regularly using rating scales such as the Adult ADHD Investigator Symptom Rating Scale (AISRS) and other assessments measuring executive function and emotional regulation. The study monitors the changes in symptoms after 3 and 10 weeks of treatment, including detailed evaluations at various hours post-dose. Safety and tolerability will also be observed, with the total participation lasting up to 10 weeks.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults ages 18-60 years at the time of consent
- Able to provide signed informed consent
- Any gender
- Diagnosed with ADHD of predominantly inattentive or combined presentation confirmed by Adult ADHD Clinical Diagnostic Scale Version 1.2
- If not currently treated for ADHD, must have a DSM AISRS 18 item total score of 28 or higher at screening
- If previously treated for ADHD, must have a DSM AISRS 18 item total score of 22 or higher at screening
- Stable dysthymia or anxiety disorders with medication unchanged for at least three weeks, as allowed by the investigator
- No stimulant medication use in the past 2 months
- Occasional marijuana use (less than 3 times per week) allowed before enrollment
- No illicit substance use at screening or during the study
You will not qualify if you...
- Known allergy or sensitivity to methylphenidate or product components
- Use of monoamine oxidase inhibitors currently or within 14 days prior to screening
- History of bipolar disorder, psychotic disorders, autism, intellectual disability (except certain mood disorders)
- Active suicidality in the past year or suicide attempt in past 2 years
- History of severe past drug dependence causing significant social or occupational problems
- Substance abuse or use within past 6 months (except limited marijuana use as allowed)
- Use of any prescribed benzodiazepines
- Unstable medical or neurological conditions including significant cardiovascular or central nervous system disorders
- Use of psychotropic medications other than stable doses of antidepressants or anti-anxiety agents
- Known nonresponse to methylphenidate treatment
- Female participants who are breastfeeding, pregnant, planning pregnancy, or males planning to father a child during and one month after the study
- Investigator discretion based on clinical judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants undergo a two-week observation stabilization period before starting treatment. Those with significant symptom changes during this period will be discontinued from the study.
Visits during the observation stabilization period as scheduled by the study
Duration - 5 or 7 weeks depending on randomization group
Participants receive open-label treatment with Jornay PM (Methylphenidate Hydrochloride Extended-Release Capsules) with dose titration based on response.
Weekly visits for up to 7 weeks
Duration - 2 weeks
Participants in the 5-week treatment group undergo a two-week observation period without receiving Jornay PM.
Visits during follow-up observation as scheduled by the study
Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
T
Terry Leon, MS, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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