The Difference in the Mechanism of Action Between Two Brands of Dexamfetamine in Adults With ADHD (NCT05621174) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Difference in the Mechanism of Action Between Two Brands of Dexamfetamine in Adults With ADHD
Netherlands1 participantsStarted 2023-04-14
Plain-language 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.
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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Questions for the trial coordinator
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1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
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What they're measuring
1
Quantified behavior Test (QbTest) - Time Active
Timeframe: 0-120 minutes after drug administration
2
Quantified behavior Test (QbTest) - Distance
Timeframe: 0-120 minutes after drug administration
3
Quantified behavior Test (QbTest) - Area
Timeframe: 0-120 minutes after drug administration
4
Quantified behavior Test (QbTest) - Micro Events
Timeframe: 0-120 minutes after drug administration
5
Quantified behavior Test (QbTest) - Motion Simplicity
Timeframe: 0-120 minutes after drug administration
6
Blood samples
Timeframe: 0-180 minutes after drug administration
7
Blood pressure
Timeframe: 0-180 minutes after drug administration
8
Trial details
NCT IDNCT05621174
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)