Mitigating Delirium With Fluvoxamine Treatment for Non-Cardiac Surgery

NCT06969287 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 202411151R21AG086855
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium; Surgery-Complications

Keywords

delirium; geriatric; surgery; fluvoxamine

Outcome Measures

Primary Outcomes (1)

• Average Monthly participant enrollment rate

  Feasibility assessed as number of eligible participants enrolled per month by an audit of the study screening and recruitment logs.

  12- months, duration of the study

Secondary Outcomes (2)

• Average Monthly screen failure rate

  12- months, duration of the study

• Average Monthly rate of withdrawal

  12- months, duration of the study

Study Arms (2)

Fluvoxamine

EXPERIMENTAL

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.

Drug: Fluvoxamine

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Fluvoxamine 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

Also known as: Oral Fluvoxamine 100 mg capsules (immediate release)

Fluvoxamine

Placebo 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

Also known as: microcrystalline cellulose

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English-speaking
• elective non-cardiac or non-intracranial surgery requiring at least a 2-day hospital length of stay

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine/Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

RECRUITING

MeSH Terms

Conditions

Delirium

Interventions

Fluvoxamine; microcrystalline cellulose

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Oximes; Hydroxylamines; Amines; Organic Chemicals

Study Officials

• Ben Palanca, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Knarr

CONTACT

3143622415; knarr.sarah@wustl.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 13, 2025
• Study Start: April 6, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Within three years of study completion
• Access Criteria: Data use agreements may be required.

Locations

US (1)