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

February 17, 2025 updated by: Glenn Dumont, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1105AZ
        • Glenn Dumont

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Magisterial Dexamphetamine
Drug: Dexamfetamine
Magisterial Dexamfetamine
Other Names:
  • Magisterial Dexamfetamine
Drug: Dexamfetamine
Tentin
Other Names:
  • Tentin
Other: Tentin
Drug: Dexamfetamine
Magisterial Dexamfetamine
Other Names:
  • Magisterial Dexamfetamine
Drug: Dexamfetamine
Tentin
Other Names:
  • Tentin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0-120 minutes after drug administration
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.
0-120 minutes after drug administration
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.
0-120 minutes after drug administration
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.
0-120 minutes after drug administration
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.
0-120 minutes after drug administration
Blood samples
Time Frame: 0-180 minutes after drug administration
For analysis of the plasma concentration of dexamfetamine.
0-180 minutes after drug administration
Blood pressure
Time Frame: 0-180 minutes after drug administration
For autonomic and adverse effects measurements. Measured in mmHg Normal value: 120/80 mmHg
0-180 minutes after drug administration
Heart rate
Time Frame: 0-180 minutes after drug administration
For autonomic and adverse effects measurements. Measured in BPM Normal value: 60-100 BPM
0-180 minutes after drug administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
45-180 minutes after drug administration
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.
0-180 minutes after drug administration
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.
0-180 minutes after drug administration

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Glenn JH Dumont, PhD, Amsterdam UMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2023

Primary Completion (Actual)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 4, 2022

First Submitted That Met QC Criteria

November 16, 2022

First Posted (Actual)

November 17, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 17, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 82695 (Registry Identifier: Centrale Commissie Mensgebonden Onderzoek (CCMO))
  • 2022-003237-19 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Privacy protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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