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.

Recruiting

• Conditions: ADHD; attention deficit hyperactivity disorder; 10009841

• Registration Number: NL-OMON53816
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 26

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Quantified behaviour Test for analysis of objective effects.<br /><br>- Blood samples for analysis of the plasma concentration of dexamphetamine.<br /><br>- Autonomic and adverse effects measurements (vital signs): Blood pressure and<br /><br>Heart rate </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Subjective effects:<br /><br>- Addiction Research Centre Inventory (ARCI) - Acute Subjective Response to<br /><br>Substances (ASRS): Amphetamine Scale (9-11)<br /><br>- Bond-Lader Visual Analog Scale (BL-VAS)<br /><br>- QbTest performance questionnaire</p><br>