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
NYU Langone Health
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
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- No
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 treat…
Interventions
- DrugMethylphenidate 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).
Location
- NYU Langone HealthNew York, New York