Clinical trial NCT06969287: Mitigating Delirium With Fluvoxamine Treatment for Non-Cardiac Surgery
Official title: Mitigating Delirium With Fluvoxamine Treatment for Non-Cardiac Surgery (MD FluNCS)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Delirium
Surgery-Complications
Keywords: delirium
geriatric
surgery
fluvoxamine
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2025-05-13
Enrollment: 46
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Oral Fluvoxamine 100 mg tablets (immediate release)

Study drug (100mg Fluvoxamine tablet or placebo) will be administered at the following times:

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
Primary purpose: PREVENTION

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 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.

Eligibility 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)

Primary outcomes:
measure: Average Monthly participant enrollment rate
timeFrame: 12- months, duration of the study
Secondary outcomes:
measure: Average Monthly screen failure rate
timeFrame: 12- months, duration of the study
measure: Average Monthly rate of withdrawal
timeFrame: 12- months, duration of the study
measure: Average rate of delirium outcome capture
timeFrame: 12-months, duration of study
Other outcomes:
measure: Average rate of study drug administration
timeFrame: 12-months, duration of study
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine/Barnes-Jewish Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Ben Palanca, MD
role: PRINCIPAL_INVESTIGATOR
References: