Managing Delirium with FLUvoxamine treatment in Non-Cardiac Surgical patients: a feasibility trial

Phase 3

Recruiting

• Conditions: Delirium; Non-Cardiac Surgery; Neurological - Other neurological disorders; Surgery - Other surgery; Mental Health - Other mental health disorders

• Registration Number: ACTRN12622000862741
• Lead Sponsor: Royal Prince Alfred Hosptial

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-17
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Elective non-cardiac, non-intracranial surgical patients who are older than 60 years old with an expected length of hospital stay of >2 days

Exclusion Criteria

Non-english speaking
Participants who may have received an investigational new drug within the last 7 days/weeks.
Participants who lack capacity to provide informed consent.
Participants with prior known intolerance/allergy to SSRIs or fluvoxamine.
Planned postoperative ventilation
Patients on medications that interact with fluvoxamine: hepatic metabolism by CYP1A2 (theophylline, clozapine, tizadine, olanzapine), metabolism inhibited by fluvoxamine (diazepam, alprazolam, phenytoin), sigma-1
agonists/antagonists (donepezil, sertraline), risk of serotonin syndrome (St John’s Wort, selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility assessed as number of eligible participants enrolled per month at a single site (Royal Prince Alfred Hospital) by an audit of the study screening and recruitment log. [ Assessed quarterly for the 12- month duration of the study.]