OverweightANTILOPNCT04147000
Pharmacokinetics and Pharmacodynamics of Oral Sertraline Before and After Bariatric Surgery
An observational study of Overweight and Depression, run by Linkoeping University at 2 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Overweight, Depression, Anxiety Disorders
- How many people
- 3 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Jan 2020to 12 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Volunteers scheduled for bariatric surgery in one of the two participating surgical clinics. Consecutive sampling until 30 volunteers are recruited.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Lindesbergs lasarett
Lindesberg, Örebro County, 71135
Vrinnevisjukhus
Norrköping, Östergötland County, 60379
About this study
Official title: Pharmacokinetics and Pharmacodynamics of Oral Sertraline Before and After Bariatric Surgery; a Prospective Open Observational Study
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.
Read the 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).
- Conditions
- Overweight, Depression, Anxiety Disorders
- Keywords
- Pharmacokinetics, Pharmacodynamics
- Medical subject headings
- Overweight, Depression, Anxiety Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Area under the concentration curve of sertraline
Changes in the area under sertraline serum concentration vs time curve (AUC(0-t))
Measured: 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.
Measured: 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.
Measured: 8 weeks before, 1, 6 and 12 month after bariatric surgery
Secondary outcomes (1)
Changes in the area under concentration vs time curve of desmethylsertraline
Changes in the area under concentration vs time curve of desmethylsertraline
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start1 Jan 2020
- Primary completion12 Nov 2023
- Study completion12 Nov 2023
Why it stopped: Problem with recruiting as a consequence of COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Örebro University, Sweden
- Responsible party
- Principal investigator, Michael Andresen, Linkoeping University
- Investigators
- Michael Andresen, MD, Principal investigator, Linkoping university, Örebro universityYlva Böttiger, Professor, Study director, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147000
- Sponsor's protocol ID
- ANTILOP
- Acronym
- ANTILOP
- Status last verified
- Mar 2024
- First submitted
- 28 Oct 2019
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Pharmacodynamics of Oral Sertraline Before and After Bariatric Surgery; a Prospective Open Observational Study
- ClinicalTrials.gov ID
- NCT04147000
- Acronym / sponsor ID
- ANTILOP / ANTILOP
- Conditions
- Overweight, Depression, Anxiety Disorders
- Keywords
- Pharmacokinetics, Pharmacodynamics
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Problem with recruiting as a consequence of COVID-19
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Örebro University, Sweden
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 12 Nov 2023 (actual)
- Study completion
- 12 Nov 2023 (actual)
- First posted
- 31 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers scheduled for bariatric surgery in one of the two participating surgical clinics. Consecutive sampling until 30 volunteers are recruited.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Area under the concentration curve of sertraline
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
Changes in the area under sertraline serum concentration vs time curve (AUC(0-t))
Change in Clinical Anxiety Scale
Time frame: 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)
Time frame: 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.
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Problem with recruiting as a consequence of COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Andresen, MD principal investigator
Linkoping university, Örebro university
Ylva Böttiger, Professor study director
Linkoeping University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Depression, run by Linkoeping University at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Problem with recruiting as a consequence of COVID-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Area under the concentration curve of sertraline (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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.