Pharmacokinetics of SSRI/SNRI After Bariatric Surgery

Study Overview
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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.

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

Conditions
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Obesity, Depression

Intervention / Treatment
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* Procedure: Roux-en-Y gastric bypass, sleeve gastrectomy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SSRI/SNRI, bariatric surgery