Pharmacokinetics and Pharmacodynamics of Oral Sertraline Before and After Bariatric Surgery

Depression Clinical Trial

— ANTILOP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04147000
• Other study ID #: ANTILOP
• Status: Terminated
• Start date: January 1, 2020
• Est. completion date: November 12, 2023

Study information

• Verified date: March 2024
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: November 12, 2023
• Est. primary completion date: November 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Overweight

Locations

Country	Name	City	State
Sweden	Lindesbergs lasarett	Lindesberg	Örebro
Sweden	Vrinnevisjukhus	Norrköping	Östergötland

Sponsors (2)

Lead Sponsor	Collaborator
Linkoeping University	Örebro University, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Area under the concentration curve of sertraline	Changes in the area under sertraline serum concentration vs time curve (AUC(0-t))	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
Primary	Change in Clinical Anxiety Scale	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.	8 weeks before, 1, 6 and 12 month after bariatric surgery
Primary	Change in Montgomery-Åsberg-depression rating scale (MADRS-B)	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.	8 weeks before, 1, 6 and 12 month after bariatric surgery
Secondary	Changes in the area under concentration vs time curve of desmethylsertraline	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