bariatric surgery antidepressivs antipsychotics dosage
Conditions
Interventions
n.v.t. Het draait om een observationeel onderzoek met invasieve metingen.
Sponsors
St Antonius hospital
Eligibility
Inclusion criteria
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 between 18 and 60 years old; - 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 • Clomipramine • Haloperidol • Clozapine • Imipramine • Olanzapine • Paroxetine • Risperidon • Sertraline • Venlafaxine • Zuclopenthixol • Fluvoxamine • Fluoxetine • Citalopram • Quetiapine
Exclusion criteria
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Main 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary 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 | — |
Outcome results
None listed