Pharmacokinetics of SSRI/SNRI After Bariatric Surgery

NCT04928937 | Completed

• 1 other identifier: 2021IJO00233
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Depression

Keywords

SSRI/SNRI; bariatric surgery

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

bariatric surgery

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

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

conservative therapy

consisting of medical visits, nutritional counseling, physiotherapy, anti-obesogenic medication and psychological coaching

Interventions

Roux-en-Y gastric bypass, sleeve gastrectomy PROCEDURE

bariatric surgery with the goal loosing weight

bariatric surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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".

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Luzerner Kantonsspital: lead
• University Hospital, Zürich: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator

Study Sites (1)

Luzerner Kantonsspital

Lucerne, Switzerland

Location

MeSH Terms

Conditions

Obesity; Depression

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Patrick Pasi, MD

  Universitätsspital Zürich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 16, 2021
• Study Start: February 1, 2017
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: June 16, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)