NCT06969287

Mitigating Delirium With Fluvoxamine Treatment for Non-Cardiac Surgery

Mitigating Delirium With Fluvoxamine Treatment for Non-Cardiac Surgery (MD FluNCS)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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 in geriatric patients undergoing non-cardiac non-intracranial surgery.

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 intervention. There are currently no standard pharmacologic interventions to prevent delirium in any setting. The investigation will lay the groundwork for a larger-scale Phase 3 trial geared toward advancing long-term goal of improving public health and quality of life for those at risk of postoperative delirium and related sequelae. The study assumes that neuroinflammation is a key contributor to the pathogenesis of postoperative delirium, a matter of conjecture. The investigators will directly test systemic inflammation as a proxy for neuroinflammation. The investigation will test whether fluvoxamine may be associated with reduced systemic inflammation, markers of neural dysfunction, and delirium severity. This potential therapeutic approach has potential generalizability to different clinical settings and already proved useful for COVID-19. The investigators combine the need to develop a collaborative clinical trials platform across diverse healthcare settings with key mechanistic studies that will advance our understanding of the pathogenesis of delirium. These studies will leverage high-density EEG recordings and state-of-the-art plasma biomarker collection, providing key data on the biological plausibility for a fluvoxamine effect.

Conditions

• Delirium
• Surgery-Complications

Interventions

Type	Name	Description
DRUG	Fluvoxamine	100mg Fluvoxamine Capsule 1. Day of surgery - Study drug to be taken morning of surgery and evening of surgery 2. Post-operative day 1 - Study drug to be taken morning and evening
DRUG	Placebo	Placebo Capsule 1. Day of surgery - Study drug to be taken morning of surgery and evening of surgery 2. Post-operative day 1 - Study drug to be taken morning and evening

Timeline

• Start date: 2026-03-07
• Primary completion: 2027-04-01
• Completion: 2028-04-01
• First posted: 2025-05-13
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study