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Mitigating Delirium With Fluvoxamine Treatment for Non-Cardiac Surgery

NCT ID: NCT06969287

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2028-04-01

Brief Summary

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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

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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

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Delirium Surgery-Complications

Keywords

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delirium geriatric surgery fluvoxamine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Participants randomized using the randomization model in REDCAP. Study drug/placebo will be provided by an external pharmacy. Study drugs will be numbered and patients allocated to study drug using a randomisation model. Unblinding will only occur when the study finishes or if safety issues require.

Study Groups

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Fluvoxamine

100 mg of fluvoxamine on the morning of surgery (POD 0), 100 mg on the evening of surgery (POD 0), 100 mg on the morning of POD 1, and 100 mg on the evening of POD 1. All administered as PO capsules.

Group Type EXPERIMENTAL

Fluvoxamine

Intervention Type DRUG

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

Placebo

Placebo capsule on the morning of surgery (POD 0), Placebo capsule on the evening of surgery (POD 0), Placebo capsule on the morning of POD 1, and Placebo capsule on the evening of POD 1. All administered PO.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Oral Fluvoxamine 100 mg capsules (immediate release) microcrystalline cellulose

Eligibility Criteria

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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)
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ben Palanca, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine/Barnes-Jewish Hospital

St Louis, Missouri, United States

Site Status

Countries

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United States

Central Contacts

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Sarah Knarr

Role: CONTACT

Phone: 3143622415

Email: [email protected]

Other Identifiers

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R21AG086855

Identifier Type: NIH

Identifier Source: secondary_id

View Link

202411151

Identifier Type: -

Identifier Source: org_study_id