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NCT Number: NCT04928937

Pharmacokinetics of SSRI/SNRI After Bariatric Surgery

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Luzerner Kantonsspital

Lucerne, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Roux-en-Y gastric bypass, sleeve gastrectomy

Procedure

bariatric surgery with the goal loosing weight

Primary outcomes

  1. Change in SSRI/SNRI blood levels after surgery

    Time frame: Change in SSRI/SNRI blood levels at 4 weeks and 6 months after surgery

    Blood analysis: blood samples were drawn at the predefined time period (corresponding to the presumed Tmax) after ingesting the SSRI/SNRI

  2. Change in BDI (Beck Depression Inventory) II questionnaire scores after surgery

    Time frame: Change in BDI II questionnaire scores at 4 weeks and 6 months 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).

Sponsors and collaborators

Lead sponsor

Luzerner Kantonsspital

Other

Collaborators

  • Insel Gruppe AG, University Hospital Bern
  • University Hospital, Zürich

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 16, 2021
Registry last updated
Jun 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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