Preliminary guidance on how to support these patients in clinical practice will be derived. Primary objective is the change in drug concentrations in plasma (therapeutic drug monitoring) (mg/L) of the psychotropic drug after bariatric surgery (at 1…
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
Primairy study endpoint is the change in drug concentrations in plasma
(therapeutic drug monitoring) (mg/L) of the psychotropic drug after bariatric
surgery (at 1, 3, 6 and 12 months) compared to the drug concentrations in
plasma (therapeutic drug monitoring) before bariatric surgery corrected by the
dosage and between postbariatric surgery intervals.
Secondary outcome
Secondary study endpoint is:
- the change in mental status, evaluated by the Brief Symptom Inventory (BSI)-
questionnaire, after bariatric surgery (at 1, 3, 6 and 12 months), compared to
before bariatric surgery and between postbariatric surgery intervals.
Background summary
Worldwide obesity is a growing problem. In 2016 half of the Dutch population
had a body mass index (BMI) of 30 kg/m2 or higher, of which 16% is obese [1].
Morbid obesity (i.e. BMI> 40 kg/m2) is associated with many comorbidities and
reduced life expectancy [2]. Beside cardiovascular (26%) and antidiabetic drugs
(26%), analgesics (21%), anti-inflammatory and antirheumatic products
(non-steroids) (10%), antidepressants (21%), thyroid therapeutics (12%) and
drugs for obstructive airway diseases (25%) are commonly used in these patients
[3].
Bariatric surgery or weight-loss surgery is the only treatment for morbid
obesity (BMI > 40) that has been shown to produce long term weight loss. In
2017 an estimated 10000 patients underwent bariatric surgery in the Netherlands
[4]. Several metabolic surgical techniques are available including
restrictive/malabsorptive procedures. Of these techniques, the Roux-Y-gastric
bypass (RYGB) and the gastric sleeve are the most commonly performed procedures
[4].
Bariatric surgery can influence both the prevalence and incidence of
comorbidities (as a result of weight loss), and the pharmacokinetics of drugs
(because of bypass or reduction of the stomach and intestines). After bariatric
surgery, the use of a drug may be continued or stopped, and the dosage or
dosage form may be changed because of adverse drug events or to achieve an
optimal therapeutic effect. Currently, little is known about the need to adjust
the dosage or dosage form after bariatric surgery. In practice, pharmacists
receive a lot of questions about dosages after bariatric surgery from doctors,
nurses and patients.
In the Netherlands an estimated 20% of the bariatric surgery population uses
one or more psychotropic drugs [3]. Psychotropic drugs include antidepressants,
antipsychotics and psychostimulants. There is a lack of systematic information
about the number of side effects and/or treatment failure after bariatric
surgery in this population. In clinical practice, destabilization of the mental
illness occurs regularly in patients using psychotropic drugs after bariatric
surgery. This is undesirable given the vulnerability of this patient group. The
number of side effects and/or treatment failure after bariatric surgery are
missing this population. From one study we know the use of antidepressants
decreased with 15% after bariatric surgery [4]. Another study showed that
patients taking Selective Serotonin Reuptake Inhibitors (SSRI) were at risk for
reduced drug bioavailability one month after RYGB. Multiple studies advice
close monitoring of patients using psychotropic drugs after bariatric surgery
to evaluate the short-term and long-term safety and efficacy of their drug
regimen [6-16]. There is a strong need for guidelines on how to monitor obese
patients using psychotropic drugs after bariatric surgery. Currently there is
no (national) consensus on whether patients using these drugs need additional
monitoring or plasma level evaluations.
The aim of this observational pilot study is to determine the effect of RYGB or
Gastric Sleeve on the drug concentrations in plasma (therapeutic drug
monitoring) of psychotropic drugs and mental status in patients with
psychopathology. Based on these results, preliminary guidance on how to support
these patients in clinical practice will be derived.
Study objective
Preliminary guidance on how to support these patients in clinical practice will
be derived.
Primary objective is the change in drug concentrations in plasma (therapeutic
drug monitoring) (mg/L) of the psychotropic drug after bariatric surgery (at 1,
3, 6 and 12 months) compared to the drug concentrations in plasma (therapeutic
drug monitoring) before bariatric surgery and between postbariatric surgery
intervals.
Secondary objective is:
- the change in mental status, evaluated by the Brief Symptom Inventory (BSI)
questionnaire, after bariatric surgery (at 1, 3, 6 and 12 months), compared to
before bariatric surgery and between postbariatric surgery intervals.
Other objectives are:
- exploration of a relationship between the drug concentrations in plasma
(therapeutic drug monitoring) of the psychotropic drug and mental status,
evaluated by the BSI questionnaire.
- evaluation of the dosage and dosage form during the year after bariatric
surgery (at 1, 3, 6 and 12 months).
Study design
It is an observational pilot study.
Study burden and risks
Patients participating in this observational study receive standard care and
additional blood sampling and a questionnaire at standard visits. The standard
of care constitutes of five visits: before and at 1, 3, 6 and 12 months after
bariatric surgery. No extra visits are required provided. Each visit endures 30
minutes.
At the visits before surgery, 6 months and 12 months after surgery, blood
sampling is standard care. In this study an extra blood sample will be taken.
At the visits 1 month and 3 months after surgery no blood sampling is standard
care. Blood sampling will be done for this study.
Each visit patients will be asked to fill in a questionnaire which requires 8
minutes per questionnaire.
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:, - Indication for bariatric surgery (i.e. Body Mass
Index (BMI) > 40 kg/m2 or BMI> 35 kg/m2 with additional risk factors) at St
Antonius hospital. Bariatric surgery includes the following procedures:
laparoscopic (mini-) gastric bypass or laparoscopic sleeve gastrectomy;
- Participant >= 18 years, who uses one of de following psychotropic drugs* for
anxiety and depression;
- ASA physical classification II or III;
- Participant is able and willing to sign the Informed Consent form before the
screening;
- Intake and follow up by the Dutch Obesity Clinic (in groups sessions);
- Participant suffers from psychopathology and uses one of the following
psychotropic drugs:
• Amitriptyline
• Nortriptyline
• Paroxetine
• Sertraline
• Venlafaxine
• Fluvoxamine
• Fluoxetine
• Citalopram
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Known allergy for the administered medicine;
- Pregnancy or breast-feeding. This is an exclusion criterion for bariatric
surgery (participants are informed by their surgeon and bariatric nurse). Women
of childbearing age who use contraceptive methods are allowed to participate in
the study.
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 |
|---|---|
| Other | 29544 |
| CCMO | NL65049.100.18 |