Fluvoxamine to reduce delirium after non-cardiac surgery
Official title: Mitigating Delirium With Fluvoxamine Treatment for Non-Cardiac Surgery (MD FluNCS)
Run by Washington University School of Medicine · NCT06969287 · Data updated 2026-11-12
This study will test whether giving fluvoxamine around the time of elective non-cardiac, non-intracranial surgery can help reduce postoperative delirium in older adults who will stay in the hospital at least two days.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 60 Years and up |
| Sex | All |
| Enrollment | 46 (estimated) |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Status | Recruiting |
| Started | April 6, 2026 |
| Main results expected | April 1, 2027 |
| Study ends | April 1, 2028 |
| Registry record updated | April 29, 2026 |
| Trial ID | NCT06969287 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are English-speaking older adults having elective non-cardiac, non-intracranial surgery with an expected hospital stay of at least two days who can give informed consent and have no contraindications to SSRIs.
✕Probably not a fit
Patients with prior SSRI or fluvoxamine intolerance, planned postoperative ventilation, active drug or alcohol dependence, inability to consent, or taking medications with serious interactions are excluded and unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Older adults undergoing elective non-cardiac, non-intracranial surgery are randomized to receive fluvoxamine or placebo in this Phase 3 effort. Investigators will measure systemic inflammatory markers as a proxy for neuroinflammation, high-density EEG, plasma biomarkers of neural injury, and delirium severity and incidence after surgery. The work is designed to establish biological plausibility and the collaborative infrastructure needed for a larger multisite trial while testing whether fluvoxamine affects inflammation and clinical delirium outcomes. Clinical outcomes are combined with mechanistic biomarker studies to improve understanding of delirium pathogenesis.
Why it matters
Potential benefit: If successful, this approach could lower the incidence or severity of postoperative delirium and reduce related cognitive and functional decline in older surgical patients.
How similar studies have gone: Fluvoxamine showed promise in some COVID-19 studies and there is biological rationale for an anti-inflammatory effect, but fluvoxamine has not been proven to prevent postoperative delirium and large trials are lacking.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * English-speaking * elective non-cardiac or non-intracranial surgery requiring at least a 2-day hospital length of stay Exclusion Criteria: * 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)
Where it's running
-
Washington University School of Medicine/Barnes-Jewish Hospital
St Louis, Missouri, United States Recruiting
Study contacts
- Principal investigator: Ben Palanca, MD — Washington University School of Medicine
- Study coordinator: Sarah Knarr
- Email: knarr.sarah@wustl.edu
- Phone: 3143622415
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.