The difference in pharmacodynamic and pharmacokinetic profiles between Tentin and magistral dexamphetamine in adults with attention deficit hyperactivity disorder, a double blinded randomised crossover-controlled trial.

The difference in pharmacodynamic and pharmacokinetic profiles between Tentin and magistral dexamphetamine in adults with attention deficit hyperactivity disorder, a double blinded randomised crossover-controlled trial. - DAVE

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53816

Enrollment

Registered

2023-03-02

Start date

2023-06-30

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD attention deficit hyperactivity disorder

Interventions

The study includes a (digital) screening and two intervention days. Participants will receive one intervention on each intervention-day. All participants will receive GD and Tentin©, dosed as prescr

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: To be eligible to participate in this study, a subject must meet all the following criteria: - Participant is aged 18-64 years at time of screening. - Participant is diagnosed with ADHD according to the DSM 5 criteria. - Participant has switched from Tentin© to magistral 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 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.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - 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.

Design outcomes

Primary

Measure	Time frame
- Quantified behaviour Test for analysis of objective effects. - Blood samples for analysis of the plasma concentration of dexamphetamine. - Autonomic and adverse effects measurements (vital signs): Blood pressure and Heart rate	—

Secondary

Measure	Time frame
Subjective effects: - Addiction Research Centre Inventory (ARCI) - Acute Subjective Response to Substances (ASRS): Amphetamine Scale (9-11) - Bond-Lader Visual Analog Scale (BL-VAS) - QbTest performance questionnaire	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)