Clinical trial NCT04147000: Pharmacokinetics and Pharmacodynamics of Oral Sertraline Before and After Bariatric Surgery
Official title: Pharmacokinetics and Pharmacodynamics of Oral Sertraline Before and After Bariatric Surgery; a Prospective Open Observational Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Overweight
Depression
Anxiety Disorders
Keywords: Pharmacokinetics
Pharmacodynamics
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: Örebro University, Sweden
First posted: 2019-10-31
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteers scheduled for bariatric surgery in one of the two participating surgical clinics. Consecutive sampling until 30 volunteers are recruited.

Brief summary: 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.

Detailed 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-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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in Area under the concentration curve of sertraline
timeFrame: 8 weeks before, 1, 6 and 12 month after bariatric surgery before sertraline intake and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 24 hours post dose
measure: Change in Clinical Anxiety Scale
timeFrame: 8 weeks before, 1, 6 and 12 month after bariatric surgery
measure: Change in Montgomery-Åsberg-depression rating scale (MADRS-B)
timeFrame: 8 weeks before, 1, 6 and 12 month after bariatric surgery
Secondary outcomes:
measure: Changes in the area under concentration vs time curve of desmethylsertraline
timeFrame: 8 weeks before, 1, 6 and 12 month after bariatric surgerybefore sertraline intake and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 24 hours post dose
Other outcomes:
Locations:
city: Lindesberg
country: Sweden
facility: Lindesbergs lasarett
state: Örebro
city: Norrköping
country: Sweden
facility: Vrinnevisjukhus
state: Östergötland
Study officials:
affiliation: Linkoping university, Örebro university
name: Michael Andresen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Linkoeping University
name: Ylva Böttiger, Professor
role: STUDY_DIRECTOR
References: