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.
Trial Details
Depression is a common mental illness, and it is one of the leading causes of disease burden worldwide. Fortunately, there are many effective treatments available for depression, including lifestyle changes, psychological treatments, and medications such as antidepressants. However, not all patients will respond to the first treatment prescribed. Some patients may only experience a 'partial response', where a few treatments help their depression somewhat, but they do not achieve a full recovery. Currently, the reasons why some patients do not respond, or only experience a partial response to an antidepressant, is not fully understood. Recently, researchers have been investigating new medications that may help patients recover from depression. One of these new medications is Esketamine, which is a relatively new molecule derived from a drug called Ketamine - an anaesthetic that has been used medically for decades. Researchers have been investigating the antidepressant properties of Ketamine for a long time. It is thought that Ketamine, and its derivative, Esketamine, help to treat depression for a number of reasons. However, it is not yet known which patients benefit most from Esketamine when used in conjunction with conventional antidepressants. In addition, we do not yet understand how the effect of Esketamine is impacted by other treatments that a patient may be taking for their depression. Finally, it has not yet been investigated how patients with a partial response to an antidepressant will benefit from adding Esketamine to their therapeutic regimen without switching to a new baseline antidepressant. Therefore, there are two principle aims of this study 1) to investigate whether Esketamine is effective when added to ongoing antidepressant treatment and 2) to identify patient characteristics that will determine a therapeutic response to Esketamine in real-world practice. In patients that improve with the addition of Esketamine to their current antidepressant treatment, we hypothesize that their improvement will be determined by their personal characteristics and/or the type of treatment they are already receiving.NCT Number ACTRN12623001068651
Sponsors & Collaborators
Janssen-CilagThis company doesn't have a full profile yet, it is linked to a clinical trial.