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Recruiting Phase 4 NCT06103760

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

Trial Parameters

Condition Major Depressive Disorder
Sponsor Royal North Shore Hospital
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 162
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2023-10-31
Completion 2025-09-15
Interventions
Esketamine Nasal Spray [Spravato]

Brief 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

Eligibility Criteria

Inclusion Criteria: 1. Adults aged 18-65 years old 2. Diagnosis of Major Depressive Disorder (MDD) 3. Currently depressed 4. Had an inadequate response to 2 or more courses of antidepressants (of adequate dose and duration) 5. Be maintained on their current antidepressant medication or psychological therapy at the time of enmrolment 6. Able to understand and provide informed consent Exclusion Criteria: 1. Concurrent diagnoses: * Participants with other 'Diagnostic and Statistical Manual of Mental Disorders' (DSM-5) e.g., current substance misuse disorder, bipolar disorder, schizophrenia * Participants who are unable to understand the study and therefore unable to provide informed consent 2. Pregnancy: * Participants who are pregnant and/or breastfeeding * Participants who are not willing to avoid pregnancy for themselves or their partners during the study by using effective birth control methods 3. Current medications: * Participants taking a total daily dose of benzodiazepines greater

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