Pharmacokinetics of SSRI/SNRI After Bariatric Surgery

Pharmacokinetics of SSRI/SNRI (Selective Serotonin Reuptake Inhibitors/ Serotonin-norepinephrine Reuptake Inhibitors) After Bariatric Surgery and the Effects on Clinical Course

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.

Study Overview

• Status: Completed
• Conditions: Depression; Obesity
• Intervention / Treatment: Procedure: Roux-en-Y gastric bypass, sleeve gastrectomy

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 Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

Study Locations

• Switzerland
  • Lucerne, Switzerland
    • Luzerner Kantonsspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

As part of the regular consultation at the obesity center of the three study sites patients were assessed for participation according to the inclusion and exclusion criteria of the study. An interprofessional team decided about the treatment, consisting of gastric bypass surgery (Roux-en-Y gastric bypass [RYGB]), sleeve gastrectomy (SG) or conservative therapy (consisting of medical visits, nutritional counseling, physiotherapy, antiobesogenic medication and psychological coaching). Afterwards, patients who had met the inclusion criteria were asked for participation, and were allocated (according to the treatment option) to the "bariatric surgery group" with the two subgroups "gastric bypass" and "sleeve gastrectomy", and to the "conservative group".

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
bariatric surgery; consisting of gastric bypass surgery: Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG)	Procedure: Roux-en-Y gastric bypass, sleeve gastrectomy; bariatric surgery with the goal loosing weight
conservative therapy; consisting of medical visits, nutritional counseling, physiotherapy, anti-obesogenic medication and psychological coaching

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in SSRI/SNRI blood levels 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 SSRI/SNRI blood levels at 4 weeks and 6 months after surgery
Change in BDI (Beck Depression Inventory) II questionnaire scores 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).	Change in BDI II questionnaire scores at 4 weeks and 6 months after surgery

Collaborators and Investigators

• Sponsor: Luzerner Kantonsspital
• Collaborators: University Hospital Inselspital, Berne; University Hospital, Zürich
• Investigators: Principal Investigator: Patrick Pasi, MD, Universitätsspital Zürich

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: June 3, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (Actual): June 16, 2021

Study Record Updates

• Last Update Posted (Actual): June 16, 2021
• Last Update Submitted That Met QC Criteria: June 9, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: bariatric surgery; SSRI/SNRI
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 2021IJO00233

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No