ANTILOP: Pharmacokinetics and Pharmacodynamics of Oral Sertraline Before and After Bariatric Surgery

Sponsor

Linkoeping University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04147000

Collaborator

Örebro University, Sweden (Other)

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight Depression Anxiety Disorders

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).

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Pharmacokinetics and Pharmacodynamics of Oral Sertraline Before and After Bariatric Surgery; a Prospective Open Observational Study

Actual Study Start Date :

Jan 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2027

Outcome Measures

Primary Outcome Measures

Change in Area under the concentration curve of sertraline [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]
Changes in the area under sertraline serum concentration vs time curve (AUC(0-t))
Change in Clinical Anxiety Scale [8 weeks before, 1, 6 and 12 month after bariatric surgery]
Psychiatric assessment of symptoms of anxiety disorders with an 5-items-scale (Psychic tension, Ability to relax/muscular tension, Startle response/hyperarousability, Worrying, Apprehension). Every item has values between 0 (no symptoms) and 4 (marked symptoms). The overall score ranges from 0 to 20.Higher scores indicate higher anxiety symptoms.
Change in Montgomery-Åsberg-depression rating scale (MADRS-B) [8 weeks before, 1, 6 and 12 month after bariatric surgery]
Assessment of depressive symptoms with a 10-items scale (Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, Suicidal Thoughts). Higher score indicates more depressive symptoms, each item spans over a score from 0 to 6; the overall score ranges from 0 to 60.

Secondary Outcome Measures

Changes in the area under concentration vs time curve of desmethylsertraline [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]
Changes in the area under concentration vs time curve of desmethylsertraline

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lindesbergs lasarett	Lindesberg	Örebro	Sweden	71135
2	Vrinnevisjukhus	Norrköping	Östergötland	Sweden	60379

Sponsors and Collaborators

Linkoeping University
Örebro University, Sweden

Investigators

Principal Investigator: Michael Andresen, MD, Linkoping university, Örebro university
Study Director: Ylva Böttiger, Professor, Linkoeping University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michael Andresen, Principal Investigator, Linkoeping University

ClinicalTrials.gov Identifier:

NCT04147000

Other Study ID Numbers:

ANTILOP

First Posted:

Oct 31, 2019

Last Update Posted:

Sep 1, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Michael Andresen, Principal Investigator, Linkoeping University

Pharmacokinetics

Pharmacodynamics

Additional relevant MeSH terms:

Overweight

Anxiety Disorders

Study Results

No Results Posted as of Sep 1, 2021