Recruiting
Phase 3

Fluvoxamine

Sponsor:

Washington University School of Medicine

Code:

NCT06969287

Conditions

Delirium

Surgery-Complications

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Fluvoxamine

Placebo

Study Details

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

Study ID

NCT06969287

Start date

Apr 6, 2026

Status verified date

Apr, 2026

Completion date

Apr 1, 2028

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

46 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

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

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Sarah Knarr

3143622415knarr.sarah@wustl.edu

Locations

Washington University School of Medicine/Barnes-Jewish Hospital

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Sarah Knarr

314-362-2415knarr.sarah@wustl.edu

Principal Investigator:

Ben Palanca, MD

More Information

Sponsor

Washington University School of Medicine

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Keywords

  • delirium
  • geriatric
  • surgery
  • fluvoxamine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-04-29.