Fluvoxamine for Delirium

(MD FluNCS Trial)

Overseen By Sarah Knarr

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Washington University School of Medicine

Must not be taking: SSRIs, TCAs, St John's Wort

Disqualifiers: Drug dependence, Alcohol dependence, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 2 days

46 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Ben Palanca, MD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for older adults undergoing non-heart, non-brain surgery who may be at risk of postoperative delirium. The study aims to include those who can potentially benefit from fluvoxamine treatment to reduce this risk.

Inclusion Criteria

English-speaking

I am scheduled for a non-heart or brain surgery that requires a hospital stay of at least 2 days.

Exclusion Criteria

Received investigational drug within the last 7 weeks

I am unable to understand or sign the consent form.

Prior known intolerance or allergy to SSRIs or fluvoxamine

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either fluvoxamine or placebo on the day of surgery and the following day

2 days

In-hospital administration on surgery day and Post-Operative Day 1

Follow-up

Participants are monitored for delirium using the 3D Confusional Assessment Method (3D-CAM) twice daily from Post-Operative Days 1-4

4 days

In-hospital monitoring

Long-term Follow-up

Participants are monitored for safety and effectiveness over the 12-month study duration

12 months

Treatment Details

Interventions

• Fluvoxamine

Trial Overview The study is testing whether fluvoxamine, a medication typically used for mental health conditions, can help prevent confusion and disorientation (delirium) after surgery compared to a placebo (a substance with no active drug).

Participant Groups

Group I: Fluvoxamine Experimental Treatment 1 Intervention

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 II: Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+