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NCT Number: NCT05621174

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Glenn Dumont

Amsterdam, North Holland, 1105AZ, Netherlands

About this study

Objectives The primary objective is to compare the pharmacological profile of the magisterial form of dexamfetamine sulfate to the pharmacological profile of the brand-name form of dexamfetamine (Tentin©) in adult patients diagnosed with attention deficit hyperactivity disorder (ADHD) and assess whether there is a difference between pk/pd profiles of the two forms of dexamfetamine. The secondary objective is to assess how pharmacokinetic variability influences the objective and subjective (side) effects experienced by adult patients with ADHD.

Measurements At three moments (0, 60 and 120 minutes after drug administration) on each intervention-day, participants will complete the QbTest to assess objective performance and the QbPerformance to assess subjective performance. At eight moments (0, 45, 60, 75, 90, 120, 150 and 180 minutes after drug administration) on each intervention-day, participants will undergo blood sampling to determine dexamfetamine plasma concentrations and vital sign measurements for safety monitoring and possible outcome-effects. At eight moments (0, 45, 60, 75, 90, 120, 150 and 180 minutes after drug administration) on each intervention-day, participants will fill out questionnaires to assess subjective experiences.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexamfetamine

Drug

Magisterial Dexamfetamine

Other names: Magisterial Dexamfetamine

Primary outcomes

  1. Quantified behavior Test (QbTest) - Time Active

    Time frame: 0-120 minutes after drug administration

    Time Active for analysis of objective effects. The Quantified behaviour Test (QbTest) provides data to assess the three core symptoms of ADHD, that is: hyperactivity, inattention and impulsivity. Time Active (in %) is one of the scores used to measure hyperactivity, inattention and impulsivity. For the current study cardinal outcomes will be derived from a Principal Component Analysis.

  2. Quantified behavior Test (QbTest) - Distance

    Time frame: 0-120 minutes after drug administration

    Distance for analysis of objective effects. The Quantified behaviour Test (QbTest) provides data to assess the three core symptoms of ADHD, that is: hyperactivity, inattention and impulsivity. Distance (in meters) is one of the scores used to measure hyperactivity, inattention and impulsivity. For the current study cardinal outcomes will be derived from a Principal Component Analysis.

  3. Quantified behavior Test (QbTest) - Area

    Time frame: 0-120 minutes after drug administration

    Area for analysis of objective effects. The Quantified behaviour Test (QbTest) provides data to assess the three core symptoms of ADHD, that is: hyperactivity, inattention and impulsivity. Area (in cm2) is one of the scores used to measure hyperactivity, inattention and impulsivity. For the current study cardinal outcomes will be derived from a Principal Component Analysis.

  4. Quantified behavior Test (QbTest) - Micro Events

    Time frame: 0-120 minutes after drug administration

    Micro Events for analysis of objective effects. The Quantified behaviour Test (QbTest) provides data to assess the three core symptoms of ADHD, that is: hyperactivity, inattention and impulsivity. Micro Events (in millimeters) is one of the scores used to measure hyperactivity, inattention and impulsivity. For the current study cardinal outcomes will be derived from a Principal Component Analysis.

  5. Quantified behavior Test (QbTest) - Motion Simplicity

    Time frame: 0-120 minutes after drug administration

    Motion Simplicity for analysis of objective effects. The Quantified behaviour Test (QbTest) provides data to assess the three core symptoms of ADHD, that is: hyperactivity, inattention and impulsivity. Motion Simplicity (in %) is one of the scores used to measure hyperactivity, inattention and impulsivity. For the current study cardinal outcomes will be derived from a Principal Component Analysis.

  6. Blood samples

    Time frame: 0-180 minutes after drug administration

    For analysis of the plasma concentration of dexamfetamine.

  7. Blood pressure

    Time frame: 0-180 minutes after drug administration

    For autonomic and adverse effects measurements. Measured in mmHg Normal value: 120/80 mmHg

  8. Heart rate

    Time frame: 0-180 minutes after drug administration

    For autonomic and adverse effects measurements. Measured in BPM Normal value: 60-100 BPM

Secondary outcomes

  1. Addiction Research Centre Inventory (ARCI) - Acute Subjective Response to Substances (ASRS): Amphetamine Scale

    Time frame: 45-180 minutes after drug administration

    Subjective effects measurement In this trial, only amphetamines will be administered, therefore only the first 11 questions of the amphetamine-scale will be used. The investigators have adjusted the 'true-false' questions in the amphetamine-scale to Visual Analog Scale (VAS)-questions, since VASs are more sensitive to subtle changes than Likert-scales and VAS enables rapid completion leading to a lower participant burden. The ARCI questions 1 t/m 11 are in line with the therapeutic effects of dexamfetamine.

    For each question, the VAS can be marked between 0 and 10 cm, 0 meaning 'not at all' and 10 meaning 'very much' when answering the questions.

  2. Bond-Lader Visual Analog Scale (BL-VAS)

    Time frame: 0-180 minutes after drug administration

    Subjective effects measurement The Bond & Lader VAS Mood Rating Scale (BL-VAS) is used to measure the effects of drugs on the participants' mood. It consists of 16 dimensions (VAS) of mood. Ultimately, these dimensions are combined to create the following dimensions: alertness, contentedness, and calmness.

    For each question, the VAS can be marked between 0 and 10 cm, 0 meaning 'not at all' and 10 meaning 'very much' when answering the questions.

  3. QbTest performance questionnaire

    Time frame: 0-180 minutes after drug administration

    Subjective effects measurement QbPerformance to assess subjective performance on the QbTest.

    For 1 question, a 'yes' or 'no' answer will be given. For 3 questions, the VAS can be marked between 0 and 10 cm, 0 meaning 'not at all' and 10 meaning 'very much' when answering the questions.

Other outcomes

  1. Leeds Sleep Evaluation Questionnaire (LSEQ)

    Time frame: Before drug administration

    Sleep deprivation can negatively impact attention functioning in adults with and without ADHD. Sleep deprived participants performed worse on the QbTest. Therefore, the sleep quality of participants must be taken into account. The Leeds Sleep Evaluation Questionnaire (LSEQ) consists of ten bipolar 100mm visual analogue scales (VAS) questions that are associated with sleep. The LSEQ covers the following four aspects of sleep, namely: getting to sleep, quality of sleep, awakening from sleep and behavior following wakefulness (F1-CRF). The LSEQ has provided evidence for validity in clinical research. Furthermore, the LSEQ has been cross-culturally validated in multiple countries and languages. The LSEQ is a consistent, reliable and validated tool to evaluate sleep and should therefore be included in the current study. Participants will be asked to fill in the questionnaire once at baseline (T=0), since it only evaluates the sleep quality of participants of the night before.

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Official study title

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

Acronym: DAVE

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Nov 17, 2022
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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