Actively Recruiting

Age: 18Years - 70Years
All Genders
ID03476525

Bariatric Surgery and Pharmacokinetics Fluoxetine: BAR-MEDS Fluoxetine

Led by Norwegian University of Science and Technology · Updated on 2025-06-06

12

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

N

Norwegian University of Science and Technology

Lead Sponsor

S

St. Olavs Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to understand how bariatric surgery, such as gastric bypass and sleeve gastrectomy, affects the way the body processes fluoxetine, a medication commonly prescribed for depression. Changes in stomach acidity, emptying time, and digestive enzyme activity after surgery may alter the availability of fluoxetine in the bloodstream. The study is observational and focuses on patients with morbid obesity preparing for these surgeries in Central Norway. Participants will continue their usual prescription of fluoxetine while the study monitors how the surgery influences its concentration in their blood over time. The main measurement is the area under the curve (AUC) of fluoxetine concentration in blood serum, tracked from before surgery up to one year afterwards. No experimental treatments or placebo groups are involved. During the study, participants undergo regular blood tests to measure fluoxetine levels. Researchers observe these changes without altering prescribed medication. The study is led by the Norwegian University of Science and Technology and involves adult Norwegian citizens aged 18 to 70 who are planning bariatric surgery. Participation lasts from baseline through one year post-surgery, focusing on medication processing changes after the operation.

CONDITIONS

Brief Title

Bariatric Surgery and Pharmacokinetics of Fluoxetine

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
  • Being a Norwegian citizen
  • Aged between 18 and 70 years
  • Currently prescribed fluoxetine medication
Not Eligible

You will not qualify if you...

  • Having previously undergone resections in the gastrointestinal tract

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to 1 week or until discharge

Participants undergo bariatric surgery including gastric bypass or sleeve gastrectomy and receive immediate post-operative care.

1 surgery visit and approximately 3 post-operative visits

Long-term Monitoring

Duration - Up to 1 year

Participants are monitored to evaluate fluoxetine concentration in blood serum from baseline to 1 year after surgery.

Periodic visits for blood sample collection over 1 year

Trial Site Locations

Total: 1 location

1

St. Olavs University Hospital

Trondheim, Norway

Actively Recruiting

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Research Team

M

Magnus Strømmen, MSc

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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