Pharmacokinetics and Pharmacodynamics of Oral Sertraline Before and After Bariatric Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2023-11-12

Brief Summary

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Volunteers with a prescription of oral sertraline who have been scheduled to bariatric surgery in either Norrköping/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.

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Detailed Description

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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-τ) 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).

Conditions

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Overweight Depression Anxiety Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* scheduled to undergo either gastric bypass or gastric sleeve surgery via surgeon clinics in Örebro or Norrköping
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No