ADHD Attention deficit hyperactivity disorder
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Participant is aged between 18 * 60 years at time of diagnosis Participant is diagnosed with ADHD according to the DSM 5 criteria Participant started pharmacotherapy treatment with dex or lisdex but no real preference for the type of amphetamine exists according to the practitioner Participant is able to provide written informed consent Participant is able and willing to comply with the study protocol
Exclusion criteria
Exclusion criteria: No diagnosis for ADHD Currently other psychopharmacotherapy treatment than dex or lisdex Currently other psychopharmacotherapy parallel to dex or lisdex
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. The PD profiles will be compared to the PK profiles to objectify the day-time response variation for both types of amphetamines. The main study parameters will include: 1. Comparison of the PK/PD profile | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study parameters will include: 1. Compare the AUC (T0-12) of dex and lisdex 2. The effects at Cmax and Tmax will be compared i. QbTest ii. The Drug Effects Questionnaire (DEQ) iii. Bond-Lader Visual Analog Scale (BL-VAS) iv. QbTest performance questionnaire v. Cardiovascular response other study parameters: Other study parameters that will be recorded include the following baseline values that are considered to influence the primary and secondary endpoints: 1. The Leeds Sleep Evaluation Questionnaire (LSEQ) 2. Comparison of baseline characteristics | — |
Countries
Netherlands
Outcome results
None listed