Pharmacokinetics of SSRI/SNRI After Bariatric Surgery

Sponsor
Luzerner Kantonsspital (Other)
Overall Status
Completed
CT.gov ID
NCT04928937
Collaborator
University Hospital, Zürich (Other), University Hospital Inselspital, Berne (Other)
63
1
35.9
1.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Roux-en-Y gastric bypass, sleeve gastrectomy

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.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
63 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Pharmacokinetics of SSRI/SNRI (Selective Serotonin Reuptake Inhibitors/ Serotonin-norepinephrine Reuptake Inhibitors) After Bariatric Surgery and the Effects on Clinical Course
Actual Study Start Date :
Feb 1, 2017
Actual Primary Completion Date :
Jan 31, 2020
Actual Study Completion Date :
Jan 31, 2020

Arms and Interventions

Arm Intervention/Treatment
bariatric surgery

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

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

conservative therapy

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

Outcome Measures

Primary Outcome Measures

  1. Change in SSRI/SNRI blood levels after surgery [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 [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Luzerner Kantonsspital Lucerne Switzerland

Sponsors and Collaborators

  • Luzerner Kantonsspital
  • University Hospital, Zürich
  • University Hospital Inselspital, Berne

Investigators

  • Principal Investigator: Patrick Pasi, MD, Universitätsspital Zürich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Luzerner Kantonsspital
ClinicalTrials.gov Identifier:
NCT04928937
Other Study ID Numbers:
  • 2021IJO00233
First Posted:
Jun 16, 2021
Last Update Posted:
Jun 16, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Luzerner Kantonsspital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 16, 2021