Attention Deficit Disorder With HyperactivityDAVENCT05621174

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

A study testing Dexamfetamine in people with Attention Deficit Disorder With Hyperactivity, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Attention Deficit Disorder With Hyperactivity
What is being tested?: Dexamfetamine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 1 siteNetherlands
Study dates: 14 Apr 2023to 31 Dec 2025
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Glenn Dumont
Amsterdam, North Holland, 1105AZ

Other trials in Netherlands

About this study

Official 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

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.

Read the 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.

Conditions: Attention Deficit Disorder With Hyperactivity
Being tested: Dexamfetamine
Keywords: Attention Deficit Disorder with Hyperactivity, Attention Deficit Hyperactivity Disorder, ADHD, ADD, AD(H)D
Medical subject headings: Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DexamfetamineDrug
Also called Magisterial Dexamfetamine
Magisterial Dexamfetamine
DexamfetamineDrug
Also called Tentin
Tentin

Study groups in NCT05621174
Study group	Role	What they receive
Magisterial Dexamphetamine	Other	Magisterial Dexamphetamine Receives: Drug: Dexamfetamine
Tentin	Other	Tentin Receives: Drug: Dexamfetamine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

Addiction Research Centre Inventory (ARCI) - Acute Subjective Response to Substances (ASRS): Amphetamine Scale
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.
Measured: 45-180 minutes after drug administration
Bond-Lader Visual Analog Scale (BL-VAS)
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.
Measured: 0-180 minutes after drug administration
QbTest performance questionnaire
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.
Measured: 0-180 minutes after drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Apr 202331 Dec 2025

First posted17 Nov 2022
Study start14 Apr 2023
Primary completion31 Dec 2024
Study completion31 Dec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05621174
Sponsor's protocol ID: 82695
Other IDs: 2022-003237-19, 82695
Acronym: DAVE
Status last verified: Feb 2025
First submitted: 4 Nov 2022
Last updated: 18 Feb 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Privacy protocol

Publications

Lott DC, Kim SJ, Cook EH, de Wit H. Serotonin transporter genotype and acute subjective response to amphetamine. Am J Addict. 2006 Sep-Oct;15(5):327-35. doi: 10.1080/10550490600859868.
PubMed 16966188
Martin WR, Sloan JW, Sapira JD, Jasinski DR. Physiologic, subjective, and behavioral effects of amphetamine, methamphetamine, ephedrine, phenmetrazine, and methylphenidate in man. Clin Pharmacol Ther. 1971 Mar-Apr;12(2):245-58. doi: 10.1002/cpt1971122part1245. No abstract available.
PubMed 5554941
Wong YN, Wang L, Hartman L, Simcoe D, Chen Y, Laughton W, Eldon R, Markland C, Grebow P. Comparison of the single-dose pharmacokinetics and tolerability of modafinil and dextroamphetamine administered alone or in combination in healthy male volunteers. J Clin Pharmacol. 1998 Oct;38(10):971-8. doi: 10.1002/j.1552-4604.1998.tb04395.x.
PubMed 9807980
Dolder PC, Strajhar P, Vizeli P, Hammann F, Odermatt A, Liechti ME. Pharmacokinetics and Pharmacodynamics of Lisdexamfetamine Compared with D-Amphetamine in Healthy Subjects. Front Pharmacol. 2017 Sep 7;8:617. doi: 10.3389/fphar.2017.00617. eCollection 2017.
PubMed 28936175
Dan O, Cohen A, Asraf K, Saveliev I, Haimov I. The Impact of Sleep Deprivation on Continuous Performance Task Among Young Men With ADHD. J Atten Disord. 2021 Jul;25(9):1284-1294. doi: 10.1177/1087054719897811. Epub 2020 Jan 9.
PubMed 31916494
Parrott AC, Hindmarch I. The Leeds Sleep Evaluation Questionnaire in psychopharmacological investigations - a review. Psychopharmacology (Berl). 1980;71(2):173-9. doi: 10.1007/BF00434408.
PubMed 6777817
Tarrasch R, Laudon M, Zisapel N. Cross-cultural validation of the Leeds sleep evaluation questionnaire (LSEQ) in insomnia patients. Hum Psychopharmacol. 2003 Dec;18(8):603-10. doi: 10.1002/hup.534.
PubMed 14696019
Manzar MD, Salahuddin M, Maru TT, Alghadir A, Anwer S, Bahammam AS, Pandi-Perumal SR. Validation of the adapted Leeds sleep evaluation questionnaire in Ethiopian university students. Health Qual Life Outcomes. 2018 Mar 13;16(1):49. doi: 10.1186/s12955-018-0876-0.
PubMed 29534726
Haertzen CA. Development of scales based on patterns of drug effects, using the addiction Research Center Inventory (ARCI). Psychol Rep. 1966 Feb;18(1):163-94. doi: 10.2466/pr0.1966.18.1.163. No abstract available.
PubMed 5908477
HILL HE, HAERTZEN CA, WOLBACH AB Jr, MINER EJ. THE ADDICTION RESEARCH CENTER INVENTORY: STANDARDIZATION OF SCALES WHICH EVALUATE SUBJECTIVE EFFECTS OF MORPHINE, AMPHETAMINE, PENTOBARBITAL, ALCOHOL, LSD-25, PYRAHEXYL AND CHLORPROMAZINE. Psychopharmacologia. 1963 May 15;4:167-83. doi: 10.1007/BF02584089. No abstract available.
PubMed 14048539
Lader MH, Bond AJ. Interaction of pharmacological and psychological treatments of anxiety. Br J Psychiatry Suppl. 1998;(34):42-8.
PubMed 9829016
Setnik B, Roland CL, Pixton G, Webster L. Measurement of Drug Liking in Abuse Potential Studies: A Comparison of Unipolar and Bipolar Visual Analog Scales. J Clin Pharmacol. 2017 Feb;57(2):266-274. doi: 10.1002/jcph.801. Epub 2016 Aug 23.
PubMed 27444046
Ahearn EP. The use of visual analog scales in mood disorders: a critical review. J Psychiatr Res. 1997 Sep-Oct;31(5):569-79. doi: 10.1016/s0022-3956(97)00029-0.
PubMed 9368198
Ashinoff BK, Abu-Akel A. Hyperfocus: the forgotten frontier of attention. Psychol Res. 2021 Feb;85(1):1-19. doi: 10.1007/s00426-019-01245-8. Epub 2019 Sep 20.
PubMed 31541305
Schmid Y, Hysek CM, Simmler LD, Crockett MJ, Quednow BB, Liechti ME. Differential effects of MDMA and methylphenidate on social cognition. J Psychopharmacol. 2014 Sep;28(9):847-56. doi: 10.1177/0269881114542454. Epub 2014 Jul 22.
PubMed 25052243

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Attention Deficit Disorder With Hyperactivity trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT05621174
Acronym / sponsor ID: DAVE / 82695
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: Attention Deficit Disorder with Hyperactivity, Attention Deficit Hyperactivity Disorder, ADHD, ADD, AD(H)D
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 1 participants (actual)
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
Study start: 14 Apr 2023 (actual)
Primary completion: 31 Dec 2024 (actual)
Study completion: 31 Dec 2025 (estimated)
First posted: 17 Nov 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Magisterial Dexamphetamine	Other	Drug: DexamfetamineMagisterial Dexamphetamine
Tentin	Other	Drug: DexamfetamineTentin

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DexamfetamineAlso: Magisterial DexamfetamineMagisterial Dexamfetamine	Drug	Magisterial Dexamphetamine
DexamfetamineAlso: TentinTentin	Drug	Tentin

Primary outcome

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

3 secondary outcomes

Addiction Research Centre Inventory (ARCI) - Acute Subjective Response to Substances (ASRS): Amphetamine Scale
Time frame: 45-180 minutes after drug administration
Bond-Lader Visual Analog Scale (BL-VAS)
Time frame: 0-180 minutes after drug administration
QbTest performance questionnaire
Time frame: 0-180 minutes after drug administration

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
Background: PubMed 16966188Lott DC, Kim SJ, Cook EH, de Wit H. Serotonin transporter genotype and acute subjective response to amphetamine. Am J Addict. 2006 Sep-Oct;15(5):327-35. doi: 10.1080/10550490600859868.
Background: PubMed 5554941Martin WR, Sloan JW, Sapira JD, Jasinski DR. Physiologic, subjective, and behavioral effects of amphetamine, methamphetamine, ephedrine, phenmetrazine, and methylphenidate in man. Clin Pharmacol Ther. 1971 Mar-Apr;12(2):245-58. doi: 10.1002/cpt1971122part1245. No abstract available.
Background: PubMed 9807980Wong YN, Wang L, Hartman L, Simcoe D, Chen Y, Laughton W, Eldon R, Markland C, Grebow P. Comparison of the single-dose pharmacokinetics and tolerability of modafinil and dextroamphetamine administered alone or in combination in healthy male volunteers. J Clin Pharmacol. 1998 Oct;38(10):971-8. doi: 10.1002/j.1552-4604.1998.tb04395.x.
Background: PubMed 28936175Dolder PC, Strajhar P, Vizeli P, Hammann F, Odermatt A, Liechti ME. Pharmacokinetics and Pharmacodynamics of Lisdexamfetamine Compared with D-Amphetamine in Healthy Subjects. Front Pharmacol. 2017 Sep 7;8:617. doi: 10.3389/fphar.2017.00617. eCollection 2017.
Background: PubMed 31916494Dan O, Cohen A, Asraf K, Saveliev I, Haimov I. The Impact of Sleep Deprivation on Continuous Performance Task Among Young Men With ADHD. J Atten Disord. 2021 Jul;25(9):1284-1294. doi: 10.1177/1087054719897811. Epub 2020 Jan 9.
Background: PubMed 6777817Parrott AC, Hindmarch I. The Leeds Sleep Evaluation Questionnaire in psychopharmacological investigations - a review. Psychopharmacology (Berl). 1980;71(2):173-9. doi: 10.1007/BF00434408.
Background: PubMed 14696019Tarrasch R, Laudon M, Zisapel N. Cross-cultural validation of the Leeds sleep evaluation questionnaire (LSEQ) in insomnia patients. Hum Psychopharmacol. 2003 Dec;18(8):603-10. doi: 10.1002/hup.534.
Background: PubMed 29534726Manzar MD, Salahuddin M, Maru TT, Alghadir A, Anwer S, Bahammam AS, Pandi-Perumal SR. Validation of the adapted Leeds sleep evaluation questionnaire in Ethiopian university students. Health Qual Life Outcomes. 2018 Mar 13;16(1):49. doi: 10.1186/s12955-018-0876-0.
Background: PubMed 5908477Haertzen CA. Development of scales based on patterns of drug effects, using the addiction Research Center Inventory (ARCI). Psychol Rep. 1966 Feb;18(1):163-94. doi: 10.2466/pr0.1966.18.1.163. No abstract available.
Background: PubMed 14048539HILL HE, HAERTZEN CA, WOLBACH AB Jr, MINER EJ. THE ADDICTION RESEARCH CENTER INVENTORY: STANDARDIZATION OF SCALES WHICH EVALUATE SUBJECTIVE EFFECTS OF MORPHINE, AMPHETAMINE, PENTOBARBITAL, ALCOHOL, LSD-25, PYRAHEXYL AND CHLORPROMAZINE. Psychopharmacologia. 1963 May 15;4:167-83. doi: 10.1007/BF02584089. No abstract available.
Background: PubMed 9829016Lader MH, Bond AJ. Interaction of pharmacological and psychological treatments of anxiety. Br J Psychiatry Suppl. 1998;(34):42-8.
Background: PubMed 27444046Setnik B, Roland CL, Pixton G, Webster L. Measurement of Drug Liking in Abuse Potential Studies: A Comparison of Unipolar and Bipolar Visual Analog Scales. J Clin Pharmacol. 2017 Feb;57(2):266-274. doi: 10.1002/jcph.801. Epub 2016 Aug 23.
Summary of Product Characteristics - DMB 5 mgLink provided by the sponsor.
Summary of Product Characteristics - Tentin 5 mgLink provided by the sponsor.
Individual participant dataSharing planned: No. Privacy protocol

Related trials for Attention Deficit Disorder With Hyperactivity

Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
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Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
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RecruitingPhase 3
A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation
Attention-deficit/Hyperactivity Disorder, Emotional Dysregulation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Glenn JH Dumont, PhD principal investigator

Amsterdam UMC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Dexamfetamine in people with Attention Deficit Disorder With Hyperactivity, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quantified behavior Test (QbTest) - Time Active (time frame: 0-120 minutes after drug administration). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05621174, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.