The aim of this study is to describe the kinetics of venlafaxine and its metabolite o-desmethylvenlafaxine after gastric bypass surgery and to compare the kinetics of venlafaxine and O-desmethylvenlafaxine before and after a Roux-en-Y gastric bypass…
ID
Source
Brief title
Condition
- Other condition
- Mood disorders and disturbances NEC
Synonym
Health condition
bariatrische chirurgie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
AUC corrected for the dose
Secondary outcome
Cmax, Tmax and T1/2.
Background summary
Obese patients use antidepressants relatively more often than the rest of the
population. In this group of patients, adequate treatment of depressive
symptoms is important. Obese patients who undergo gastric bypass surgery
experience a major change in the gastrointestinal tract, with a possible change
in the bioavailability of drugs, such as the antidepressant venlafaxine. At
present, little is known about the effect of a Roux-en-Y gastric bypass on the
pharmacokinetics of venlafaxine. Research will improve venlafaxine treatment in
patients undergoing a Roux-en-Y gastric bypass.
Study objective
The aim of this study is to describe the kinetics of venlafaxine and its
metabolite o-desmethylvenlafaxine after gastric bypass surgery and to compare
the kinetics of venlafaxine and O-desmethylvenlafaxine before and after a
Roux-en-Y gastric bypass surgery by measuring the AUC corrected for the dose.
Study design
Observational research in which patients are their own control. Blood samples
are taken at different times during the day on five days: one month before and
one, three, six and twelve months after surgery. On the first two days, blood
samples are taken at t = 0, 2, 4, 6, 9 and 10 hours. On the last three days, a
blood sample is taken at t = 0. The blood samples are analyzed for the
concentration of venlafaxine and o-desmethylvenlafaxine.
Study burden and risks
The participant is given a one-off blood test before the first day of research
to determine the activity of the CYP2D6 enzyme.
At the start of day one and two, the participant will be inserted with a
flexibele cannula (venflon). Six times during the day, blood will be taken
trough the cannula. At day three, four and five, a blood sample will be taken
through a venipuncture.
The participant of this study may only take his or her medication according to
the specifications of this study.
Participation in this study costs the participant extra time. The participant
will have to be in the hospital for a total of five days.
The participant personally benefits from participating in this study.
Subtherapeutic of (potentially) toxic concentrations measured during the study
will be discussed with the treating physician. By participating in this study,
the participant contributes to the knowledge about the pharmacokinetics of, and
thus to the future treatment with, antidepressants after bariatric surgery.
Maasstadweg 21
Rotterdam 3079 DZ
NL
Maasstadweg 21
Rotterdam 3079 DZ
NL
Listed location countries
Age
Inclusion criteria
The participant is on the waiting list for gastric bypass surgery and is using
oral venlafaxine without changes in dosages for the past four weeks.
Exclusion criteria
Persons who have previously undergone bariatric surgery.
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 | NL70138.100.19 |