Pharmacokinetics of SSRI/SNRI After Bariatric Surgery

Completed

• Conditions: Obesity; Depression
• Interventions: Procedure: Roux-en-Y gastric bypass, sleeve gastrectomy

• Registration Number: NCT04928937
• Lead Sponsor: Luzerner Kantonsspital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2017-02-01
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Status Verified: 2021-06
• Study First Submitted: 2021-06-03
• Study First Submitted QC: 2021-06-09
• Last Update Submitted: 2021-06-09
• Study First Posted: 2021-06-16
• Last Update Posted: 2021-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
bariatric surgery	Roux-en-Y gastric bypass, sleeve gastrectomy	consisting of gastric bypass surgery: Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG)

Primary Outcome Measures

Name	Time	Method
Change in SSRI/SNRI blood levels after surgery	Change in SSRI/SNRI blood levels at 4 weeks and 6 months after surgery	Blood analysis: blood samples were drawn at the predefined time period (corresponding to the presumed Tmax) after ingesting the SSRI/SNRI
Change in BDI (Beck Depression Inventory) II questionnaire scores after surgery	Change in BDI II questionnaire scores at 4 weeks and 6 months after surgery	The BDI is a psychological test that measures the severity of depressive symptoms or depression. The test procedure is a self-assessment measure including 21 questions on a four-level scale with values from 0 to 3 in terms of occurrence and intensity, providing a sum value between 0 and 63. Based on this value, it is possible to determine whether the person is non-depressed (0), minimally depressed, mildly depressed, moderate to severely depressed or severely depressed (63).

Trial Locations

Locations (1)

Luzerner Kantonsspital; 🇨🇭 Lucerne, Switzerland