The Difference in the Mechanism of Action Between Two Brands of Dexamfetamine in Adults With ADHD

• Status: Not yet recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: 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/A
• Accepts Healthy Volunteers?: No

Details

• 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.