Health TrialsbyHealthPanel

Mitigating Delirium With Fluvoxamine Treatment for Non-Cardiac Surgery

ConditionsDeliriumSurgery-Complications
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age60+
SponsorWashington University School of Medicine

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

English-speaking

elective non-cardiac or non-intracranial surgery requiring at least a 2-day hospital length of stay

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: FluvoxamineExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Average Monthly participant enrollment rate

Feasibility assessed as number of eligible participants enrolled per month by an audit of the study screening and recruitment logs.

Time frame
12- months, duration of the study

Secondary outcomes

1

Average Monthly screen failure rate

Feasibility assessed as number of screening failures per month by an audit of the study screening and recruitment logs.

Time frame
12- months, duration of the study
2

Average Monthly rate of withdrawal

Feasibility assessed as number of withdrawals per month by an audit of the study screening and recruitment logs.

Time frame
12- months, duration of the study

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

National Institute on Aging (NIA)

Collaborator

Source ClinicalTrials.gov
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