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

This naturalistic, open-label, single-arm intervention trial (n=162) conducted by Royal North Shore Hospital aims to assess the effects of esketamine in treating depression.

The study seeks to determine Esketamine’s effectiveness when added to ongoing antidepressant treatment and to identify patient characteristics influencing therapeutic response in real-world settings.

Participants, aged 18-65 with Major Depressive Disorder (MDD), will self-administer intranasal esketamine under supervision at the clinic, followed by a 2-hour observation period including blood pressure monitoring and questionnaire completion. Esketamine will be administered twice weekly for weeks 1-4, then once weekly for weeks 5-8, and less frequently thereafter as clinically indicated up to week 25.

Primary outcomes include the percentage of treatment responders based on a 50% reduction in Hamilton Depression Rating Scale (HAM-D) 17-Item scores at the end of week 4. Secondary outcomes encompass changes in mood and anxiety symptoms, assessed through various scales.

Eligible participants must have had inadequate responses to two or more courses of antidepressants, be maintained on current antidepressant medication or psychological therapy, and provide informed consent. Exclusion criteria include concurrent diagnoses such as substance misuse disorders, pregnancy, specific medications, and medical history factors.

Recruitment is ongoing at Royal North Shore Hospital, New South Wales, Australia, with an estimated study completion date of January 2026.

Trial Details

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

NCT Number NCT06103760

Data attribution

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