Study of Evening-Dosed Jornay PM Extended-Release Capsules for Adults Aged 18 to 60 with ADHD Evaluating Symptom Control, Executive Function, and Emotional Regulation Throughout the Day

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-deficithyperactivity 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.

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