ObesityNCT04928937
Pharmacokinetics of SSRI/SNRI After Bariatric Surgery
An observational study of Obesity and Depression, run by Luzerner Kantonsspital at 1 site in Switzerland.
Trial summary
Psychiatric disorders and treatment with antidepressants SSRI/SNRI (selective serotonin reuptake inhibitors/ serotonin-norepinephrine reuptake inhibitors) are common in people with morbid obesity who are candidates for bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Depression
- What is being tested?
- Roux-en-Y gastric bypass, sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 63 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2017to 31 Jan 2020
- How long will I take part?
- 8 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: As part of the regular consultation at the obesity center of the three study sites patients were assessed for participation according to the inclusion and exclusion criteria of the study. An interprofessional team decided about the treatment, consisting of gastric bypass surgery (Roux-en-Y gastric bypass [RYGB]), sleeve gastrectomy (SG) or conservative therapy (consisting of medical visits, nutritional counseling, physiotherapy, antiobesogenic medication and psychological coaching). Afterwards, patients who had met the inclusion criteria were asked for participation, and were allocated (according to the treatment option) to the "bariatric surgery group" with the two subgroups "gastric bypass" and "sleeve gastrectomy", and to the "conservative group".
Who may be able to join
- Age >18 years
- BMI >35
- Existing antidepressant drug therapy with SSRI or SNRI
- Written informed consent
Who cannot join
- Taking other psychotropic drugs than SSRI/SNRI
- Active drug addiction or psychosis
- Severe depression (BDI score >30)
- Suicidality at the beginning of the study
- Gastrointestinal malabsorption
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics of SSRI/SNRI (Selective Serotonin Reuptake Inhibitors/ Serotonin-norepinephrine Reuptake Inhibitors) After Bariatric Surgery and the Effects on Clinical Course
Psychiatric disorders and treatment with antidepressants SSRI/SNRI (selective serotonin reuptake inhibitors/ serotonin-norepinephrine reuptake inhibitors) are common in people with morbid obesity who are candidates for bariatric surgery. Although longitudinal assessments reveal positive effects of bariatric surgery on quality of life and mood, depressive disorders may also deteriorate after bariatric surgery. There is few and inconsistent data about the postoperative pharmacokinetics of SSRI/SNRI. The aims of our study were to provide comprehensive data about the postoperative bioavailability of SSRI/SNRI, and the clinical effects on the course of depression.
Read the detailed description
Prospective multicenter study including 63 patients (i.e. 46 participants in the bariatric surgery group, and 17 participants in the conservative group as controls) with morbid obesity and therapy with SSRI/SNRI: participants filled the Beck Depression Inventory II (BDI) questionnaire, and plasma levels of SSRI/SNRI were measured by HPLC (High Performance Liquid Chromatography), preoperatively (T0), 4 weeks (T1) and 6 months (T2) postoperatively.
- Conditions
- Obesity, Depression
- Being tested
- Roux-en-Y gastric bypass, sleeve gastrectomy
- Keywords
- SSRI/SNRI, bariatric surgery
- Medical subject headings
- Obesity, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux-en-Y gastric bypass, sleeve gastrectomyProcedure or surgery
bariatric surgery with the goal loosing weight
| Study group | Role | What they receive |
|---|---|---|
| bariatric surgery | consisting of gastric bypass surgery: Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG) Receives: Procedure: Roux-en-Y gastric bypass, sleeve gastrectomy | |
| conservative therapy | consisting of medical visits, nutritional counseling, physiotherapy, anti-obesogenic medication and psychological coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SSRI/SNRI blood levels after surgery
Blood analysis: blood samples were drawn at the predefined time period (corresponding to the presumed Tmax) after ingesting the SSRI/SNRI
Measured: Change in SSRI/SNRI blood levels at 4 weeks and 6 months after surgery
Change in BDI (Beck Depression Inventory) II questionnaire scores after surgery
The BDI is a psychological test that measures the severity of depressive symptoms or depression. The test procedure is a self-assessment measure including 21 questions on a four-level scale with values from 0 to 3 in terms of occurrence and intensity, providing a sum value between 0 and 63. Based on this value, it is possible to determine whether the person is non-depressed (0), minimally depressed, mildly depressed, moderate to severely depressed or severely depressed (63).
Measured: Change in BDI II questionnaire scores at 4 weeks and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start1 Feb 2017
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- 63 participants (actual)
- Target duration
- 8 Months
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Zürich, Insel Gruppe AG, University Hospital Bern
- Responsible party
- Sponsor
- Investigators
- Patrick Pasi, MD, Principal investigator, Universitätsspital Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928937
- Sponsor's protocol ID
- 2021IJO00233
- Status last verified
- Jun 2021
- First submitted
- 3 Jun 2021
- Last updated
- 16 Jun 2021
- 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 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of SSRI/SNRI (Selective Serotonin Reuptake Inhibitors/ Serotonin-norepinephrine Reuptake Inhibitors) After Bariatric Surgery and the Effects on Clinical Course
- ClinicalTrials.gov ID
- NCT04928937
- Acronym / sponsor ID
- 2021IJO00233
- Conditions
- Obesity, Depression
- Keywords
- SSRI/SNRI, bariatric surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Collaborators
- University Hospital, Zürich, Insel Gruppe AG, University Hospital Bern
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 16 Jun 2021 (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.
Psychiatric disorders and treatment with antidepressants SSRI/SNRI (selective serotonin reuptake inhibitors/ serotonin-norepinephrine reuptake inhibitors) are common in people with morbid obesity who are candidates for bariatric surgery. Although longitudinal assessments reveal positive effects of bariatric surgery on quality of life and mood, depressive disorders may also deteriorate after bariatric surgery. There is few and inconsistent data about the postoperative pharmacokinetics of SSRI/SNRI. The aims of our study were to provide comprehensive data about the postoperative bioavailability of SSRI/SNRI, and the clinical effects on the course of depression.
Detailed description
Prospective multicenter study including 63 patients (i.e. 46 participants in the bariatric surgery group, and 17 participants in the conservative group as controls) with morbid obesity and therapy with SSRI/SNRI: participants filled the Beck Depression Inventory II (BDI) questionnaire, and plasma levels of SSRI/SNRI were measured by HPLC (High Performance Liquid Chromatography), preoperatively (T0), 4 weeks (T1) and 6 months (T2) postoperatively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bariatric surgery | – | Procedure: Roux-en-Y gastric bypass, sleeve gastrectomyconsisting of gastric bypass surgery: Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG) |
| conservative therapy | – | –consisting of medical visits, nutritional counseling, physiotherapy, anti-obesogenic medication and psychological coaching |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- As part of the regular consultation at the obesity center of the three study sites patients were assessed for participation according to the inclusion and exclusion criteria of the study. An interprofessional team decided about the treatment, consisting of gastric bypass surgery (Roux-en-Y gastric bypass [RYGB]), sleeve gastrectomy (SG) or conservative therapy (consisting of medical visits, nutritional counseling, physiotherapy, antiobesogenic medication and psychological coaching). Afterwards, patients who had met the inclusion criteria were asked for participation, and were allocated (according to the treatment option) to the "bariatric surgery group" with the two subgroups "gastric bypass" and "sleeve gastrectomy", and to the "conservative group".
Key inclusion criteria (4 listed)
- Age >18 years
- BMI >35
- Existing antidepressant drug therapy with SSRI or SNRI
- Written informed consent
Key exclusion criteria (6 listed)
- Taking other psychotropic drugs than SSRI/SNRI
- Active drug addiction or psychosis
- Severe depression (BDI score >30)
- Suicidality at the beginning of the study
- Gastrointestinal malabsorption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roux-en-Y gastric bypass, sleeve gastrectomybariatric surgery with the goal loosing weight | Procedure or surgery | bariatric surgery |
Primary outcome
Change in SSRI/SNRI blood levels after surgery
Time frame: Change in SSRI/SNRI blood levels at 4 weeks and 6 months after surgery
Blood analysis: blood samples were drawn at the predefined time period (corresponding to the presumed Tmax) after ingesting the SSRI/SNRI
Change in BDI (Beck Depression Inventory) II questionnaire scores after surgery
Time frame: Change in BDI II questionnaire scores at 4 weeks and 6 months after surgery
The BDI is a psychological test that measures the severity of depressive symptoms or depression. The test procedure is a self-assessment measure including 21 questions on a four-level scale with values from 0 to 3 in terms of occurrence and intensity, providing a sum value between 0 and 63. Based on this value, it is possible to determine whether the person is non-depressed (0), minimally depressed, mildly depressed, moderate to severely depressed or severely depressed (63).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- 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.
Patrick Pasi, MD principal investigator
Universitätsspital Zürich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Depression, run by Luzerner Kantonsspital at 1 site in Switzerland.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 SSRI/SNRI blood levels after surgery (time frame: Change in SSRI/SNRI blood levels at 4 weeks and 6 months after surgery). The study lists 2 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 16 Jun 2021.