Actively Recruiting
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
Led by NYU Langone Health · Updated on 2026-04-29
30
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 aged 18 to 60 years at the time of consent
- Able to provide signed informed consent
- Any gender
- Current primary DSM-5 diagnosis of ADHD of predominantly inattentive or combined presentation confirmed by the Adult ADHD Clinical Diagnostic Scale Version 1.2
- If not currently treated with ADHD medication, DSM AISRS 18-item total score of 28 or higher at screening
- If previously treated with ADHD medication, DSM AISRS 18-item total score of 22 or higher at screening
- Dysthymia and anxiety disorders in remission and stable on psychiatric medication for 3 weeks or more, with medication remaining constant during the study
- No stimulant medication use in the past 2 months
- Occasional marijuana use (less than 3 times weekly) allowed during screening but must abstain during the study
- No illicit substance use at screening or during the study
You will not qualify if you...
- Known hypersensitivity to methylphenidate or product components
- Current or recent (within 14 days) use of monoamine oxidase inhibitors (MAOIs)
- Lifetime bipolar disorder, psychotic disorders, autism, intellectual disability (except mood disorders allowed at investigator discretion)
- Active suicidality within past year or suicide attempt within past 2 years
- History of severe past drug dependence causing major social or occupational problems
- Substance abuse or use within 6 months, except limited marijuana use as defined
- Use of prescribed benzodiazepines
- Unstable medical or neurological conditions including significant cardiovascular or central nervous system diseases
- Use of psychotropic medications other than stable antidepressants or anti-anxiety agents
- Known nonresponse to methylphenidate treatment
- History of allergic reaction or sensitivity to methylphenidate
- Females who are breastfeeding, pregnant, planning to become pregnant, or males planning to father a child during the study or for one month after
- Investigator or clinician discretion
AI-Screening
AI-Powered Screening
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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
CONTACT
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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