The effect of bariatric surgery on pharmacotherapy of psychotropic drugs in clinical practice

Phase 4

Completed

Conditions: bariatrische chirurgie
bariatric surgery
10027946

Registration Number: NL-OMON55606

Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primairy study endpoint is the change in drug concentrations in plasma<br /><br>(therapeutic drug monitoring) (mg/L) of the psychotropic drug after bariatric<br /><br>surgery (at 1, 3, 6 and 12 months) compared to the drug concentrations in<br /><br>plasma (therapeutic drug monitoring) before bariatric surgery corrected by the<br /><br>dosage and between postbariatric surgery intervals.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study endpoint is:<br /><br>- the change in mental status, evaluated by the Brief Symptom Inventory (BSI)-<br /><br>questionnaire, after bariatric surgery (at 1, 3, 6 and 12 months), compared to<br /><br>before bariatric surgery and between postbariatric surgery intervals.</p><br>