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The Day-time Response Variation of (Lis)Dexamphetamine

NCT04946461 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 16

Last updated 2023-05-10

No results posted yet for this study

Summary

In the Netherlands, two forms of amphetamines are available for the treatment of ADHD in adults; dexamfetamine (Tentin) and lisdexamfetamine (Elvanse) and both belong to regular and primary care pharmacotherapy. Both drugs contain exactly the same substance dexamfetamine and it would be expected that the effects on the symptoms of ADHD and the duration of action should be comparable. Previous studies and daily practice have reported different effects and duration of action of both, however. In this study the investigators want to investigate this difference by giving both drugs to the same patient, objectify the blood concentrations, objective and subjective effects and hope to be able to further optimize the treatment for ADHD with amphetamines.

Conditions

  • Adhd

Interventions

DRUG

Dexamfetamine Sulfate 5 Mg Oral Tablet

The dosage is set based on the recommendation of the practitioner. Dexamphetamine is administered twice a day, with an interval of 4 hours.

DRUG

Lisdexamfetamine Dimesylate

The dosage is set based on the recommendation of the practitioner. Lisdexamphetamine is only administered once a day.

BIOLOGICAL

blood samples

The blood samples will be taken at set times: 0, 2, 4, 6, 9 and 12 (hours)

Sponsors & Collaborators

  • ADHDcentraal

    collaborator UNKNOWN

  • Amsterdam UMC, location VUmc

    lead OTHER

Principal Investigators

  • R. Mathot, PhD · AUMC, location AMC

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2021-12-30
Completion
2022-06-16
FDA Drug
Yes

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04946461 on ClinicalTrials.gov