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Clinical trial

Objectifying the Day-time Response Variation of (Lis)Dexamphetamine in Adults With ADHD

ID
Name
NL77195.018.21
Description
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.
Trial arms
Trial start
2021-07-01
Estimated PCD
2021-12-30
Trial end
2022-06-16
Status
Completed
Treatment
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.
Arms:
group 1; lisdex - dex, group 2; dex - lisdex
Other names:
Tentin
Lisdexamfetamine Dimesylate
The dosage is set based on the recommendation of the practitioner. Lisdexamphetamine is only administered once a day.
Arms:
group 1; lisdex - dex, group 2; dex - lisdex
Other names:
Elvanse
blood samples
The blood samples will be taken at set times: 0, 2, 4, 6, 9 and 12 (hours)
Arms:
group 1; lisdex - dex, group 2; dex - lisdex
Other names:
vena puncture
Size
16
Primary endpoint
Quantified behavior Test (QbTest)
Two consecutive days; the QbTest assessments will be conducted at 6 time points during each day. At baseline (0), repeated after 2, 4, 6, 9 and 12 (hours)
Drug Effects Questionnaire (DEQ)
Two consecutive days; the DEQ assessments will be conducted at 6 time points during each day. At baseline (0), repeated after 2, 4, 6, 9 and 12 (hours)
Bond-Lader Visual Analog Scale (BL-VAS)
Two consecutive days; the BL-VAS assessments will be conducted at 6 time points during each day. At baseline (0), repeated after 2, 4, 6, 9 and 12 (hours)
QbTest performance questionnaire
Two consecutive days; the QbTest performance questionnaire assessments will be conducted at 6 time points during each day. At baseline (0), repeated after 2, 4, 6, 9 and 12 (hours)
systolic blood pressure (mmHg)
Two consecutive days; the cardiovasculaire assessments will be conducted at 6 time points during each day. At baseline (0), repeated after 2, 4, 6, 9 and 12 (hours)
Diastolic blood pressure (mmHg)
Two consecutive days; the cardiovasculaire assessments will be conducted at 6 time points during each day. At baseline (0), repeated after 2, 4, 6, 9 and 12 (hours)
Heart rate (heart beats per minute)
Two consecutive days; the cardiovasculaire assessments will be conducted at 6 time points during each day. At baseline (0), repeated after 2, 4, 6, 9 and 12 (hours)
Plasma concentration of D-amphetamine
Two consecutive days; the plasma concentration of D-amphetamine will be determined at 6 time points during each day. At baseline (0), repeated after 2, 4, 6, 9 and 12 (hours)
Eligibility criteria
Inclusion Criteria: 1. Participant is aged between 18 - 60 years at time of diagnosis 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: 1. No diagnosis for ADHD 2. Currently other psychopharmacotherapy treatment than dex or lisdex 3. Currently other psychopharmacotherapy parallel to dex or lisdex
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'A total of 12 blood samples (2 ml per sample) per subject will be taken.'}, 'enrollmentInfo': {'count': 16, 'type': 'ACTUAL'}}
Updated at
2023-05-10

1 organization

3 products

1 indication

Organization
Amsterdam UMC
Product
Dexamfetamine Sulfate
Indication
ADHD
Product
Lisdexamfetamine
Product
Blood samples