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
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. Contact the study team or a site near you to ask about taking part.
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.
- 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