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

NCT05621174 | Active Not Recruiting

• 2 other identifiers: 826952022-003237-19
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Attention Deficit Disorder with Hyperactivity; Attention Deficit Hyperactivity Disorder; ADHD; ADD; AD(H)D

Outcome Measures

Primary Outcomes (8)

• Quantified behavior Test (QbTest) - Time Active

  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

  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

  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

  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

  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

  For analysis of the plasma concentration of dexamfetamine.

  0-180 minutes after drug administration

• Blood pressure

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

  0-180 minutes after drug administration

• Heart rate

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

  0-180 minutes after drug administration

Secondary Outcomes (3)

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

  45-180 minutes after drug administration

• Bond-Lader Visual Analog Scale (BL-VAS)

  0-180 minutes after drug administration

• QbTest performance questionnaire

  0-180 minutes after drug administration

Other Outcomes (1)

• Leeds Sleep Evaluation Questionnaire (LSEQ)

  Before drug administration

Study Arms (2)

Magisterial Dexamphetamine

OTHER

Magisterial Dexamphetamine

Drug: Dexamfetamine

Tentin

OTHER

Tentin

Drug: Dexamfetamine

Interventions

Dexamfetamine DRUG

Magisterial Dexamfetamine

Also known as: Magisterial Dexamfetamine

Magisterial Dexamphetamine

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Glenn Dumont

Amsterdam, North Holland, 1105AZ, Netherlands

Location

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Related Links

• Summary of Product Characteristics - DMB 5 mg
• Summary of Product Characteristics - Tentin 5 mg

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Dextroamphetamine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Glenn JH Dumont, PhD

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 17, 2022
• Study Start: April 14, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)