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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55606

Enrollment

Registered

2019-02-25

Start date

2021-04-06

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bariatrische chirurgie bariatric surgery

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

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 >= 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

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
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

Measure	Time frame
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.	—

Countries

Netherlands

Outcome results