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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04928937
Enrollment
63
Registered
2021-06-16
Start date
2017-02-01
Completion date
2020-01-31
Last updated
2021-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Obesity

Keywords

SSRI/SNRI, bariatric surgery

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.

Interventions

PROCEDURERoux-en-Y gastric bypass, sleeve gastrectomy

bariatric surgery with the goal loosing weight

Sponsors

University Hospital, Zürich
CollaboratorOTHER
Insel Gruppe AG, University Hospital Bern
CollaboratorOTHER
Luzerner Kantonsspital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in SSRI/SNRI blood levels after surgeryChange in SSRI/SNRI blood levels at 4 weeks and 6 months after surgeryBlood 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 surgeryChange in BDI II questionnaire scores at 4 weeks and 6 months after surgeryThe 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).

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026