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.
ID
Source
Brief title
Condition
- Developmental disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
In the Netherlands, two types of amphetamines are available for the treatment
of adults with ADHD: dexamphetamine sulfate (dex [Tentin ]) and
Lisdexamphetamine dimesylate (lisdex [Elvanse ]). Lisdex is promoted by the
manufacturer as a long-acting preparation with a controlled release profile and
thus an extended duration of action compared to dex, however, the scientific
evidence about the PK/PD profile of lisdex is sparse. Additionally, there are
insufficient head-to-head comparisons between dex and lisdex where an objective
measurement for the symptom amelioration of ADHD has been used and compared to
the plasma concentrations. We hypothesize that two-times daily dex is more
effective in suppressing ADHD symptomatology than once daily lisdex.
Study objective
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.
Study design
An observational study where sixteen participants will be observed for two days
for the PK/PD profiles of lisdex and dex. Lisdex will be bioequivalently dosed;
lisdex once a day and dex two times a day with an interval of 4 hours (TAU) The
participants will be observed for approximately 14 hours each day. Blood
samples, the Quantified behavior Test (QbTest), physical measurements and
questionnaires for drug effects will be taken 6 times at; 0, 2; 4; 6; 9; 12.
Study burden and risks
There are no specific benefits for the study participants. The burden of
participating in this study include two extra visits to the outpatient clinic,
during each visit the study participant has to fill out some questionnaires,
undergo six QbTests and bloodtests. In our opinion the burden for each study
participant is considered minor and the risk very low. The therapy given during
the study is according to the TAU, which is based on the guidelines of the
Dutch association of psychiatry (NVvP) for the treatment of ADHD in adults. The
participants will be sampled for blood 12 times (2ml). We believe that this
risk is acceptable in relation to the possible benefits that may be gained from
this study, i.e. improved pharmacotherapy treatment guidelines for adult
patients with ADHD.
Meidreef 9
Amsterdam 1105 AZ
NL
Meidreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL77195.018.21 |
| Other | volgt (NCT) |