Clinical Trial

Positioning of Esketamine Treatment in the Real-world Management of Depression

Study acronym: PoET
Recruiting Phase 4
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Summary
The goal of this naturalistic, open label, single arm intervention study is to investigate the effects of Esketamine in treating depression.The main aims to answer are: * to investigate whether Esketamine is effective when added to ongoing antidepressant treatment * to identify patient characteristics that will determine a therapeutic response to Esketamine in real-world practice Participants will: * attend the clinic for supervised self-administration of intranasal Esketamine treatment * be observed for 2 hours following Esketamine administration including blood pressure monitoring * be asked to complete a battery of questionnaires * be reimbursed for travel expenses
Trial Details
NCT Number NCT06103760
Lead Sponsor Royal North Shore Hospital
Collaborators: Janssen-Cilag Pty Ltd
Conditions Major Depressive Disorder
Enrollment 162 participants
Start Date 2023-10-31
Primary Completion 2027-12-15 (estimated)
Study Completion 2028-08-15 (estimated)
Updated on ClinicalTrials.gov 2026-08-12