Overview
The Difference in the Mechanism of Action Between Two Brands of Dexamfetamine in Adults With ADHD
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2023-06-01
2023-06-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Treatments:
Dextroamphetamine
Criteria
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.