Evaluating the Positioning of Esketamine Treatment (PoET) for symptom management in adults with major depressive disorder

This uncontrolled, single-arm, naturalistic study (n=162) aims to evaluate the positioning of Esketamine Treatment (PoET) for symptom management in adults with major depressive disorder (MDD).

The study consists of three treatment phases: an acute treatment phase (weeks 1-4), a maintenance treatment phase (weeks 5-8), and a continuation treatment phase (weeks 9-25). Esketamine will be administered intranasally with an initial dose of 56mg, followed by subsequent doses of 56mg or 84mg, depending on clinical indications. Treatment frequency varies from twice weekly in the acute phase to once weekly or less frequently in the maintenance and continuation phases.

The primary outcomes include the percentage of treatment responders based on the Hamilton Depression Rating Scale (HAM-D) 17-Item scoring, mean depression score on the Quick Inventory of Depressive Symptomatology Self-report (QIDS-SR) 16-Item, and global functioning assessed by the Clinical Global Impression (CGI) score. Secondary outcomes include mood symptom scores, depressive symptoms measured by the Beck Depression Inventory (BDI) 21-Item, and anxiety symptoms evaluated using the State-Trait Anxiety Inventory (STAI).

Eligible participants are adults aged 18-65 years with a diagnosis of major depressive disorder who have had inadequate responses to two or more courses of antidepressants.

The study is conducted at the Royal North Shore Hospital in St Leonards, Australia, with funding from Janssen-Cilag Pty Ltd and support from the Northern Sydney Local Health District. The principal investigator is Prof Gin Malhi. The trial is not yet recruiting, with anticipated enrolment from October 17, 2023, to March 24, 2025.

Topic Depression
Compound Ketamine
Country Australia
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Janssen-Cilag
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