NCT06103760

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: Royal North Shore Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Esketamine Nasal Spray [Spravato]	This is an uncontrolled, single arm, naturalistic study. There will be three treatment phases: Phase 1 - Acute treatment phase (weeks 1-4); Phase 2 - Maintenance treatment phase (weeks 5-8); Phase 3 - Continuation treatment phase (Weeks 9-25). Phase 1 is the critical component of our study as it determines our primary outcomes.

Timeline

• Start date: 2023-10-31
• Primary completion: 2025-09-15
• Completion: 2026-01-15
• First posted: 2023-10-27
• Last updated: 2024-05-17

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study