Obesity, MorbidNCT03460379
Bariatric Surgery and Pharmacokinetics of Escitalopram
An observational study of Obesity, Morbid, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- Escitalopram
- How many people
- 12 participants
- Where
- 1 siteNorway
- Study dates
- 2 Nov 2016to Oct 2026
- 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: Patients referred for bariatric surgery (gastric bypass or sleeve gastrectomy)
Who may be able to join
- Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
- Being a Norwegian citizen
Who cannot join
- Having previously undergone resections in the GI-tract
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
St. Olavs University Hospital
Trondheim
Magnus Strømmen, MSc
About this study
Official title: Bariatric Surgery and Pharmacokinetics Escitalopram: BAR-MEDS Escitalopram
Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on escitalopram are investigated.
- Conditions
- Obesity, Morbid
- Being tested
- Escitalopram
- Keywords
- Bariatric surgery, Gastrointestinal tract, Biological availability, Pharmacokinetics, Citalopram
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Also called Citalopram, Cytalopram
Patients are tested for their normal prescription escitalopram medication
What is being measured
The primary outcome is the main question the study is designed to answer.
Escitalopram concentration in blood serum (area under curve (AUC))
Measured: From baseline to 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start2 Nov 2016
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Volvat Medisinsk Senter Stokkan, Namsos Hospital, Alesund Hospital
- Responsible party
- Sponsor
- Investigators
- Magnus Strømmen, MSc, Principal investigator, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460379
- Sponsor's protocol ID
- 2016/1145k
- Status last verified
- Mar 2023
- First submitted
- 4 Mar 2018
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Schoretsanitis G, Strommen M, Krabseth HM, Helland A, Spigset O. Effects of Sleeve Gastrectomy and Roux-en-Y Gastric Bypass on Escitalopram Pharmacokinetics: A Cohort Study. Ther Drug Monit. 2023 Dec 1;45(6):805-812. doi: 10.1097/FTD.0000000000001114. Epub 2023 Jun 15.
PubMed 37363832
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bariatric Surgery and Pharmacokinetics Escitalopram: BAR-MEDS Escitalopram
- ClinicalTrials.gov ID
- NCT03460379
- Acronym / sponsor ID
- 2016/1145k
- Conditions
- Obesity, Morbid
- Keywords
- Bariatric surgery, Gastrointestinal tract, Biological availability, Pharmacokinetics, Citalopram
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Volvat Medisinsk Senter Stokkan, Namsos Hospital, Alesund Hospital
- Study start
- 2 Nov 2016 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 9 Mar 2018 (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.
Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on escitalopram are investigated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for bariatric surgery (gastric bypass or sleeve gastrectomy)
Key inclusion criteria (2 listed)
- Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
- Being a Norwegian citizen
Key exclusion criteria (1 listed)
- Having previously undergone resections in the GI-tract
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 |
|---|---|---|
| EscitalopramAlso: Citalopram, CytalopramPatients are tested for their normal prescription escitalopram medication | Drug | – |
Primary outcome
Escitalopram concentration in blood serum (area under curve (AUC))
Time frame: From baseline to 1 year postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Derived from this study: PubMed 37363832Schoretsanitis G, Strommen M, Krabseth HM, Helland A, Spigset O. Effects of Sleeve Gastrectomy and Roux-en-Y Gastric Bypass on Escitalopram Pharmacokinetics: A Cohort Study. Ther Drug Monit. 2023 Dec 1;45(6):805-812. doi: 10.1097/FTD.0000000000001114. Epub 2023 Jun 15.
- Individual participant dataSharing planned: Undecided
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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.
Magnus Strømmen, MSc principal investigator
St. Olavs Hospital
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, Morbid, run by Norwegian University of Science and Technology at 1 site in Norway.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Mar 2023. 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 Norway. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Magnus Strømmen, MSc (0047 72829970, magnus.strommen@stolav.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Escitalopram concentration in blood serum (area under curve (AUC)) (time frame: From baseline to 1 year postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03460379, which also lists 1 linked publication.
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 27 Mar 2023.