The Difference in Pharmacodynamic and Pharmacokinetic Profiles Between Tentin and Magisterial Dexamfetamine in Adults With Attention Deficit Hyperactivity Disorder, a Double Blinded Randomised Crossover-controlled Trial

82695

The goal of this clinical trial is to compare in the pk/pd profiles of magisterial dexamfetamine and Tentin in adults with Attention Deficit Hyperactivity Disorder (ADHD). The main question\[s\] it aims to answer are: Q1: is there a difference between pk/pd profiles of the two forms of dexamfetamine? Q2: how does the pharmacokinetic variability influences the objective and subjective (side) effects experienced by adult patients with ADHD? Participants will: * take the Quantified behavior Test for analysis of objective effects. * undergo blood sampling for analysis of the plasma concentration of dexamphetamine. * undergo blood pressure and heart rate measurements. * fill out 4 types of questionnaires. Researchers will compare the outcomes between magisterial dexamphetamine and Tentin use in a crossover setting.

2023-04-14

2024-08-20

2024-12-31

Recruiting

26

Inclusion Criteria: * Participant is aged ≥ 18 years at time of screening. * Participant is diagnosed with ADHD according to the DSM 5 criteria. * Participant has switched from Tentin© to magisterial dexamfetamine due to the adverse effects of Tentin. * Participant is being treated adequately with dexamphetamine, as determined by their practitioner, at time of screening. * Participant or their legal representative is able and willing to provide written informed consent. * Participant is able and willing to comply with the study protocol (e.g. swallow capsules, have blood samples taken, can visit the outpatient clinic twice). * Participant has not participated in another study in the past three months. Exclusion Criteria: * Participant has a disorder that might affect drug absorption (e.g. gastrointestinal, metabolic, endocrine or liver disorder). * Participant is allergic to the ingredients of the capsules.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 26, 'type': 'ESTIMATED'}}

2023-10-12