Mitigating Delirium With Fluvoxamine Treatment for Non-Cardiac Surgery

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT06969287
Phase
PHASE3
Status
Recruiting
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Conditions

  • Delirium
  • Surgery-Complications

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

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
  • 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

Study Details

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.

Key Dates

Start date
Apr 6, 2026
Status verified
Apr 2026
Primary completion
Apr 1, 2027
Completion
Apr 1, 2028

Study Design

Enrollment
46 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: 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.
  • Placebo Comparator: 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.

Primary Outcome Measure

Average Monthly participant enrollment rate [ Time Frame: 12- months, duration of the study ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of Medicine/Barnes-Jewish HospitalSt LouisMissouri63110
Sarah Knarr
[email protected]
314-362-2415
Ben Palanca, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Washington University School of Medicine/Barnes-Jewish Hospital· St Louis, MO

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