Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
16 participants
OBSERVATIONAL
2021-07-01
2022-06-16
Brief Summary
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Detailed Description
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Objective: The objective is to compare the pharmacodynamic profile of dex and lisdex in adult patients with ADHD and determine whether the day-time response variation in ADHD symptomatology depends on the type of amphetamine and it's pharmacokinetics.
Study design: An observational study.
Study population: N=16 adults with a minimal age of 18 years old, diagnosed with ADHD according to the DSM 5 criteria, where treatment as usual (TAU) with dex or lisdex already commenced but where the optimal dosage and type of amphetamine have not been established.
Intervention: Sixteen participants will be observed for two consecutive days and PK/PD profiles of lisdex and dex will be observed. Lisdex will be bioequivalently dosed; lisdex once a day and dex two times a day with an interval of 4 hours (TAU). The participants will be observed for approximately 14 hours each day. Blood samples, the Quantified behavior Test (QbTest), physical measurements and questionnaires for drug effects will be taken 6 times at; 0, 2; 4; 6; 9; 12 (hours).
Main study parameters/endpoints: The primary study parameters are the PK/PD profile over time; next to blood samples for pharmacokinetic profiling pharmacodynamic assessments include the QbTest, the drug effect Questionnaire (DEQ), the Bond-Lader Visual Analog Scale (BL-VAS), QbTest performance questionnaire and physical measurements; blood pressure and heart rate.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are no specific benefits for the study participants. The burden of participating in this study include two extra visits to the outpatient clinic. During each visit the study participant has to fill out some questionnaires, undergo six QbTests and bloodtests. In our opinion the burden for each study participant is considered minor and the risk very low. The therapy given during the study is according to the TAU, which is based on the guidelines of the Dutch association of psychiatry (NVvP) for the treatment of ADHD in adults. The participants will undergo a total of 12 blood samples (2ml per sample). This risk is acceptable in relation to the possible benefits that may be gained from this study, i.e. improved pharmacotherapy guidelines for adult patients with ADHD.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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group 1; lisdex - dex
subjects are assigned to group 1 based on the type of medication prescribed by the practitioner. Subjects which started with lisdexamphetamine are assigned to group 1.
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.
Lisdexamfetamine Dimesylate
The dosage is set based on the recommendation of the practitioner. Lisdexamphetamine is only administered once a day.
blood samples
The blood samples will be taken at set times: 0, 2, 4, 6, 9 and 12 (hours)
group 2; dex - lisdex
subjects are assigned to group 2 based on the type of medication prescribed by the practitioner. Subjects which started with dexamphetamine are assigned to group 1.
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.
Lisdexamfetamine Dimesylate
The dosage is set based on the recommendation of the practitioner. Lisdexamphetamine is only administered once a day.
blood samples
The blood samples will be taken at set times: 0, 2, 4, 6, 9 and 12 (hours)
Interventions
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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.
Lisdexamfetamine Dimesylate
The dosage is set based on the recommendation of the practitioner. Lisdexamphetamine is only administered once a day.
blood samples
The blood samples will be taken at set times: 0, 2, 4, 6, 9 and 12 (hours)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participant is diagnosed with ADHD according to the DSM 5 criteria
3. Participant started pharmacotherapy treatment with dex or lisdex but no real preference for the type of amphetamine exists according to practitioner
4. Participant is able to provide written informed consent
5. Participant is able and willing to comply with the study protocol
Exclusion Criteria
2. Currently other psychopharmacotherapy treatment than dex or lisdex
3. Currently other psychopharmacotherapy parallel to dex or lisdex
18 Years
50 Years
ALL
No
Sponsors
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ADHDcentraal
UNKNOWN
Amsterdam UMC, location VUmc
OTHER
Responsible Party
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R.K.R.W. Wettstein
Principal investigator
Principal Investigators
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R. Mathot, PhD
Role: PRINCIPAL_INVESTIGATOR
AUMC, location AMC
Locations
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ADHDcentraal
Amsterdam, North Holland, Netherlands
Countries
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Other Identifiers
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NL77195.018.21
Identifier Type: -
Identifier Source: org_study_id
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