Pharmacokinetics of SSRI/SNRI After Bariatric Surgery

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04928937
• Other study ID #: 2021IJO00233
• Status: Completed
• Start date: February 1, 2017
• Est. completion date: January 31, 2020

Study information

• Verified date: June 2021
• Source: Luzerner Kantonsspital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Obesity

Intervention

Procedure:
• Roux-en-Y gastric bypass, sleeve gastrectomy
bariatric surgery with the goal loosing weight

Locations

Country	Name	City	State
Switzerland	Luzerner Kantonsspital	Lucerne

Sponsors (3)

Lead Sponsor	Collaborator
Luzerner Kantonsspital	University Hospital Inselspital, Berne, University Hospital, Zürich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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