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Number of Visits: 1

Duration: 2 days

Fluvoxamine for Delirium
(MD FluNCS Trial)

Not yet recruiting at 1 trial location

Overseen BySarah 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 DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if fluvoxamine, a medication typically used for mental health, can prevent confusion and memory problems (delirium) after surgery in older adults. Researchers will compare fluvoxamine to a placebo (a pill with no active drug) to assess its effectiveness. Suitable candidates for this trial are English-speaking individuals scheduled for non-heart or non-brain surgery who expect to stay in the hospital for at least two days. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

You may need to stop taking certain medications before joining the trial, especially if they have strong interactions with fluvoxamine or increase the risk of serotonin syndrome. It's best to discuss your current medications with the trial team to see if any changes are needed.

Is there any evidence suggesting that fluvoxamine is likely to be safe for humans?

Research has shown that fluvoxamine is generally safe for use. Although primarily used to treat depression, studies have found it can also help with confusion in ICU patients, suggesting potential usefulness for similar issues, such as post-surgery confusion.

However, some reports indicate that fluvoxamine may cause confusion, so doctors should monitor patients during treatment. As this trial is in a later stage, substantial information exists about fluvoxamine's safety. It is likely to be well-tolerated, but like any medication, it may have side effects. Participants should consult their doctor if they have any concerns.¹ ² ³ ⁴ ⁵

Why do researchers think this study treatment might be promising?

Researchers are excited about fluvoxamine for treating delirium because it offers a novel approach compared to standard treatments like antipsychotics and sedatives. Fluvoxamine, primarily known as an SSRI, may help manage delirium by modulating serotonin levels, which isn't the focus of traditional treatments. This could mean fewer side effects and a different, potentially more effective way to address the underlying causes of delirium. Additionally, fluvoxamine is administered in a straightforward oral capsule form, which is convenient for patients.

What evidence suggests that fluvoxamine might be an effective treatment for postoperative delirium?

Studies have shown that fluvoxamine can help treat delirium. It quickly reduced symptoms in ICU patients, as indicated by lower scores on a delirium measurement scale. In patients with Alzheimer's, using only fluvoxamine also showed promise in treating delirium. These findings suggest that fluvoxamine might help manage and lessen the severity of delirium. In this trial, participants will receive either fluvoxamine or a placebo to assess its effectiveness for patients undergoing surgery who are at risk of delirium.¹ ⁴ ⁶ ⁷ ⁸

Who Is on the Research Team?

Ben Palanca, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

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

See 4 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

2Treatment groups

Experimental Treatment

Placebo Group

Group I: FluvoxamineExperimental Treatment1 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: PlaceboPlacebo Group1 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.

Find a Clinic Near You

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+

Citations

1.pmc.ncbi.nlm.nih.govpmc.ncbi.nlm.nih.gov/articles/PMC2819237/

Sigma-1 receptor agonist fluvoxamine for delirium in patients ...To our knowledge, this is the first report demonstrating that fluvoxamine monotherapy is effective for treating the delirium of patients with Alzheimer's ...

2.journals.lww.comjournals.lww.com/ccejournal/fulltext/2025/02000/the_association_between_selective_serotonin.12.aspx

The Association Between Selective Serotonin Reuptake...The results demonstrated the rapid effectiveness of fluvoxamine in treating delirium in ICU patients, with a decrease in Delirium Rating Scale (DRS) scores, a ...

3.clinicaltrials.govclinicaltrials.gov/study/NCT06969287

Mitigating Delirium With Fluvoxamine Treatment for Non- ...The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

4.annals-general-psychiatry.biomedcentral.comannals-general-psychiatry.biomedcentral.com/articles/10.1186/1744-859X-9-18

Sigma-1 receptor agonist fluvoxamine for delirium in intensive ...Results. Delirium Rating Scale (DRS) scores in these five patients dramatically decreased after treatment with fluvoxamine.

5.pmc.ncbi.nlm.nih.govpmc.ncbi.nlm.nih.gov/articles/PMC9982784/

Association of fluvoxamine with mortality and symptom ...Effectiveness of fluvoxamine. Over a median follow-up of 5 days (IQR = 5 days) until discharge or death, 155 patients (49.05%) died. A total ...

6.clinicaltrials.govclinicaltrials.gov/study/NCT06969287

Mitigating Delirium With Fluvoxamine Treatment for Non- ...Outcome data will be uploaded to the OpenNeuro on a rolling basis. IPD Sharing Access Criteria. Data use agreements may be required. IPD Sharing Time Frame.

7.bmcgeriatr.biomedcentral.combmcgeriatr.biomedcentral.com/articles/10.1186/s12877-024-05022-0

Association between antidepressant use and delirium in older ...It is noteworthy that in the present study, both paroxetine and fluvoxamine were associated with the reports of delirium.

8.withpower.comwithpower.com/trial/phase-3-delirium-5-2025-fcd26

Fluvoxamine for Delirium (MD FluNCS Trial)Trial Overview The study is testing whether fluvoxamine, a medication typically used for mental health conditions, can help prevent confusion and disorientation ...

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