Primary objective: to determine to what extent a gastric bypass procedure has effect on the AUC (area under the serum concentration-time curve), Cmax (maximum concentration) of citalopram.Secondary objectives:- To determine the severity of…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Health condition
bariatrische chirurgie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters / endpoints: AUC (area under the serum concentration-time
curve) of citalopram.
Secondary outcome
Secondary study parameters / endpoints:
- Outcome of depression questionnaire
- Cmax (maximum serum concentration), Tmax (time of maximum serum
concentration) and T1 / 2 (half-life)
Background summary
Mental disorders are common in people with morbid obesity. In Maasstad Hospital
one of the six patients, who because of morbid obesity had a gastric bypass
surgery uses antidepressants (especially SSRIs, selective serotonin reuptake
inhibitors). As a result of the gastric bypass surgery, there is a drastic
change in the gastrointestinal tract; causing changes in drug absorption.
Possibly the reduced solubility of drugs and reduction of the absorption
surface of the gut plays a role. Some small studies show that the
bioavailability for most drugs decreased. There is hardly pharmacokinetic data
available on the effect of gastric bypass surgery on the pharmacokinetics of
SSRIs. Further research is needed to investigate the effect of gastric bypass
surgery on the pharmacokinetics so that an optimal pharmacological treatment
can be given.
Study objective
Primary objective: to determine to what extent a gastric bypass procedure has
effect on the AUC (area under the serum concentration-time curve), Cmax
(maximum concentration) of citalopram.
Secondary objectives:
- To determine the severity of depressive symptoms in SSRI users before and
after gastric bypass surgery in combination with the observed pharmacokinetic
changes.
- Determine other pharmacokinetic parameters of citalopram (Cmax (maximum serum
concentration), Tmax (time of maximum serum concentration) and T1 / 2
(half-life)).
Study design
Before-/after study; observational study
Study burden and risks
During the five days of research, the participant wille be insterted whith a
flexibele cannula (venflon) Trough this cannula blood can be taken. The risk to
the participant will be limited.
Patients will be using their own medication in the same dosage.
Maasstadweg 21
Rotterdam 3079DZ
NL
Maasstadweg 21
Rotterdam 3079DZ
NL
Listed location countries
Age
Inclusion criteria
The participant is on the waiting list for gastric bypass surgery and using oral citalopram whithout changes in dosages for at last three months.
Exclusion criteria
Persons who previously have 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 | NL43550.101.13 |