NCT06969287 Mitigating Delirium With Fluvoxamine Treatment for Non-Cardiac Surgery
| NCT ID | NCT06969287 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Washington University School of Medicine |
| Condition | Delirium |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2026-04-06 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 46 participants in total. It began in 2026-04-06 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Ben Palanca, MD
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT06969287 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Delirium. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06969287 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 46 participants.
Is NCT06969287 currently recruiting?
Yes, NCT06969287 is actively recruiting participants. Contact the research team at knarr.sarah@wustl.edu for enrollment information.
Where is the NCT06969287 trial being conducted?
This trial is being conducted at St Louis, United States.
Who is sponsoring the NCT06969287 clinical trial?
NCT06969287 is sponsored by Washington University School of Medicine. The principal investigator is Ben Palanca, MD at Washington University School of Medicine. The trial plans to enroll 46 participants.