Pharmacokinetics of SSRI/SNRI After Bariatric Surgery

L

Luzerner Kantonsspital

Status

Completed

Conditions

Obesity
Depression

Treatments

Procedure: Roux-en-Y gastric bypass, sleeve gastrectomy

Study type

Observational

Funder types

Other

Identifiers

NCT04928937
2021IJO00233

Details and patient eligibility

About

Psychiatric disorders and treatment with antidepressants SSRI/SNRI (selective serotonin reuptake inhibitors/ serotonin-norepinephrine reuptake inhibitors) are common in people with morbid obesity who are candidates for bariatric surgery. Although longitudinal assessments reveal positive effects of bariatric surgery on quality of life and mood, depressive disorders may also deteriorate after bariatric surgery. There is few and inconsistent data about the postoperative pharmacokinetics of SSRI/SNRI. The aims of our study were to provide comprehensive data about the postoperative bioavailability of SSRI/SNRI, and the clinical effects on the course of depression.

Full description

Prospective multicenter study including 63 patients (i.e. 46 participants in the bariatric surgery group, and 17 participants in the conservative group as controls) with morbid obesity and therapy with SSRI/SNRI: participants filled the Beck Depression Inventory II (BDI) questionnaire, and plasma levels of SSRI/SNRI were measured by HPLC (High Performance Liquid Chromatography), preoperatively (T0), 4 weeks (T1) and 6 months (T2) postoperatively.

Enrollment

63 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age >18 years
  • BMI >35
  • Existing antidepressant drug therapy with SSRI or SNRI
  • Written informed consent

Exclusion criteria

  • Taking other psychotropic drugs than SSRI/SNRI
  • Active drug addiction or psychosis
  • Severe depression (BDI score >30)
  • Suicidality at the beginning of the study
  • Gastrointestinal malabsorption
  • Pregnancy

Trial design

63 participants in 2 patient groups

bariatric surgery
Description:
consisting of gastric bypass surgery: Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG)
Treatment:
Procedure: Roux-en-Y gastric bypass, sleeve gastrectomy
conservative therapy
Description:
consisting of medical visits, nutritional counseling, physiotherapy, anti-obesogenic medication and psychological coaching

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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