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Positioning of Esketamine Treatment in the Real-world Management of Depression
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.
Study 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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-10-31
Primary completion: 2025-09-15
Study completion finish: 2026-01-15
Study type
TREATMENT
Phase
PHASE4
Trial ID
NCT06103760
Intervention or treatment
DRUG: Esketamine Nasal Spray [Spravato]
Conditions
- • Major Depressive Disorder
Find a site
Closest Location:
Royal North Shore Hospital
Research sites nearby
Select from list below to view details:
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
OTHER: Participants with Major Depressive Disorder
| DRUG: Esketamine Nasal Spray [Spravato]
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Percentage of treatment responders determined by a 50% reduction on the Hamilton Depression Rating Scale (HAM-D) 17-Item scoring. | Hamilton Depression Rating Scale (HAM-D) 17-Item scoring | At the end of week 4 |
Mean depression score on the Quick Inventory of Depressive Symptomatology Self-report (QIDS-SR) 16-Item. | Quick Inventory of Depressive Symptomatology Self-report (QIDS-SR) 16-Item. | Baseline, at the end of weeks 1,2,3, and 4 (primary time point); and further after week 8 and week 12 after Esketamine was commenced. |
Global functioning determined by Clinical Global Impression (CGI) score. | Clinical Global Impression (CGI) | Baseline, week 1, week 2, week 3, week 4 (primary time point), week 8 and week 12 after Esketamine was commenced. |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Change in mood symptom scores assessed using the visual analogue scale (self-reported) | Visual analogue scale (self-reported) | Baseline, after treatment day 1 and day 3 of each week until Esketamine is ceased. |
Depressive symptoms assessed using the Beck Depression Inventory (BDI) 21-Item. | Beck Depression Inventory (BDI) 21-Item. | Baseline and at week 4 after Esketamine was commenced. |
Anxiety symptoms assessed using the State-Trait Anxiety Inventory (STAI) | State-Trait Anxiety Inventory (STAI) | Baseline and at week 4 after Esketamine was commenced. |
Frequently Asked Questions
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