An observational study in Overweight, Depression and Anxiety Disorders, sponsored by Linkoeping University. Terminated at 2 sites in Sweden. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-03-22.
Sponsored by Linkoeping University · Observational
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.
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).
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's enrollment of 3 is below the median of 150 across 436 observational studies indexed under Overweight.
Browse Overweight studies →Linkoeping University is the lead sponsor of 189 studies on the registry; 40 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Volunteers scheduled for bariatric surgery in one of the two participating surgical clinics. Consecutive sampling until 30 volunteers are recruited.
Exclusion Criteria:
Change in Area under the concentration curve of sertraline
Changes in the area under sertraline serum concentration vs time curve (AUC(0-t))
Time frame: 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
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.
Time frame: 8 weeks before, 1, 6 and 12 month after bariatric surgery
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.
Time frame: 8 weeks before, 1, 6 and 12 month after bariatric surgery
Changes in the area under concentration vs time curve of desmethylsertraline
Changes in the area under concentration vs time curve of desmethylsertraline
Time frame: 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
Plan to share: No
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This study is terminated, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Linkoeping University