Trial intelligence / Profile preview

MD FluNCS: Fluvoxamine for Postoperative Delirium

NCT06969287Phase 3

Key facts

Status: Recruiting
Start: Apr 2026
Primary completion: Apr 2027
Countries: 1
Sponsor: Washington University School of Medicine
Modality: Small Molecules

Drugs: fluvoxamine
Conditions: delirium

Overview

Phase 3, randomised, double-blind trial in delirium comparing Fluvoxamine with Placebo (2 arms). Primary endpoint: Average Monthly participant enrollment rate at 12 months. Started Apr 2026; status: recruiting.

Design

2 arms

Study design: RandomizedDouble-blind

Fluvoxamine
100 mg of fluvoxamine PO twice daily on POD 0 and POD 1
Placebo
Placebo capsule PO twice daily on POD 0 and POD 1

Who it enrols

English-speaking geriatric patients undergoing elective non-cardiac or non-intracranial surgery requiring at least a 2-day hospital stay, excluding those with planned postoperative ventilation, drug/alcohol dependence, or risk of serotonin syndrome.

Endpoints

Primary

Average Monthly participant enrollment rate12 months

Secondary

Average Monthly screen failure rate12 months
Average Monthly rate of withdrawal12 months

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