Objectifying the day-time response variation of (lis)dexamphetamine in adults with ADHD.

Recruiting

Conditions: ADHD
Attention deficit hyperactivity disorder
10012562

Registration Number: NL-OMON50997

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 16

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

No diagnosis for ADHD
Currently other psychopharmacotherapy treatment than dex or lisdex
Currently other psychopharmacotherapy parallel to dex or lisdex

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The objective is to compare the pharmacodynamic profile of dex and lisdex in<br /><br>adult patients with ADHD and determine whether the day-time response variation<br /><br>in ADHD symptomatology depends on the type of amphetamine and it's<br /><br>pharmacokinetics.<br /><br>The PD profiles will be compared to the PK profiles to objectify the day-time<br /><br>response variation for both types of amphetamines.<br /><br><br /><br>The main study parameters will include:<br /><br>1. Comparison of the PK/PD profile</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study parameters will include:<br /><br>1. Compare the AUC (T0-12) of dex and lisdex<br /><br>2. The effects at Cmax and Tmax will be compared<br /><br>i. QbTest<br /><br>ii. The Drug Effects Questionnaire (DEQ)<br /><br>iii. Bond-Lader Visual Analog Scale (BL-VAS)<br /><br>iv. QbTest performance questionnaire<br /><br>v. Cardiovascular response<br /><br><br /><br>other study parameters:<br /><br>Other study parameters that will be recorded include the following baseline<br /><br>values that are considered to influence the primary and secondary endpoints:<br /><br>1. The Leeds Sleep Evaluation Questionnaire (LSEQ)<br /><br>2. Comparison of baseline characteristics</p><br>