Pharmacokinetics and Pharmacodynamics of Oral Sertraline Before and After Bariatric Surgery (ANTILOP)

  • STATUS
    Recruiting
  • End date
    Dec 11, 2027
  • participants needed
    30
  • sponsor
    Linkoeping University
Updated on 28 February 2022
sertraline

Summary

Volunteers with a prescription of oral sertraline who have been scheduled to bariatric surgery in either Norrkping/Sweden or Lindesberg/Sweden will be asked to participate in a observational study. The aim of this study is to evaluate the absorption and the effect and side effects of sertraline in volunteers 8 weeks before and 1, 6 and 12 months after bariatric surgery.

Description

The pharmacokinetic changes of sertraline after bariatric surgery are studied by assessing the exposition for sertraline in individuals with long term treatment by measuring the area under the curve (AUC0-) 8 weeks before and one, six and twelve months after bariatric surgery in 30 participants.

The effect of variation of sertraline concentration is studied by a psychiatric assessment of depressive symptoms and symptoms of anxiety disorder. The aim ist to study if there is a relation between changes in pharmacokinetics and effect of sertraline after bariatric surgery.

For the assessment of side effects a self-reporting scale is used. These participants are recruited consequentially with the aim to get equal numbers of patients with both most usual types of surgery in Sweden (laparoscopic RYGB and gastric sleeve).

Details
Condition Overweight, Depression, Anxiety Disorders
Clinical Study IdentifierNCT04147000
SponsorLinkoeping University
Last Modified on28 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

scheduled to undergo either gastric bypass or gastric sleeve surgery via surgeon clinics in rebro or Norrkping
prescription of sertraline
since at least one month
planned to be continued at the time of inclusion
swedish speaking

Exclusion Criteria

comorbidity with the consequence that the potential participant may not be able to complete the study
if participation should result in a high risk for patients health or safety
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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