Pharmacokinetics of SSRI/SNRI After Bariatric Surgery

NCT ID: NCT04928937

Last Updated: 2021-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-01

Study Completion Date

2020-01-31

Brief Summary

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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

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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.

Conditions

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Obesity Depression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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bariatric surgery

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

Roux-en-Y gastric bypass, sleeve gastrectomy

Intervention Type PROCEDURE

bariatric surgery with the goal loosing weight

conservative therapy

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

No interventions assigned to this group

Interventions

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Roux-en-Y gastric bypass, sleeve gastrectomy

bariatric surgery with the goal loosing weight

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Zürich

OTHER

Sponsor Role collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role collaborator

Luzerner Kantonsspital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick Pasi, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsspital Zürich

Locations

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Luzerner Kantonsspital

Lucerne, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2021IJO00233

Identifier Type: -

Identifier Source: org_study_id

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