Status:
NOT_YET_RECRUITING
Mitigating Delirium With Fluvoxamine Treatment for Non-Cardiac Surgery
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Delirium
Surgery-Complications
Eligibility:
All Genders
60+ years
Phase:
PHASE3
Brief Summary
The investigation will establish biological plausibility and infrastructure required for a multisite clinical trial evaluating the re-purposing of fluvoxamine to mitigate postoperative delirium risk i...
Detailed Description
Delirium is a disturbance in attention, cognition, and consciousness, an acute physiological consequence of medical events, such as hospital admission, surgery, sepsis, and pharmacological interventio...
Eligibility Criteria
Inclusion
- English-speaking
- elective non-cardiac or non-intracranial surgery requiring at least a 2-day hospital length of stay
Exclusion
- Received investigational drug within the last 7 weeks
- lack of capacity to provide informed consent
- prior known intolerance or allergy to SSRIs or fluvoxamine
- planned postoperative ventilation
- drug or alcohol dependence
- preoperative use of non-NSAID medications with drug-drug interactions of Class X (Avoid Combination) or D (Consider Therapy Modification)
- risk of serotonin syndrome (St John's Wort, SSRIs, or TCA)
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06969287
Start Date
February 1 2026
End Date
April 1 2028
Last Update
December 24 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Washington University School of Medicine/Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110