RecruitingPhase 4NCT06103760

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


Sponsor

Royal North Shore Hospital

Enrollment

162 participants

Start Date

Oct 31, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how esketamine (a fast-acting nasal spray antidepressant) is being used in real-world practice for people with treatment-resistant depression — meaning depression that hasn't improved despite trying at least two antidepressant medications. **You may be eligible if...** - You are 18–65 years old - You have been diagnosed with major depressive disorder (MDD) and are currently depressed - You have tried at least 2 antidepressant medications at adequate doses without enough relief - You are currently on an antidepressant or therapy that you plan to continue - You can understand and provide consent **You may NOT be eligible if...** - You have a diagnosis of bipolar disorder, schizophrenia, or active substance use disorder - You are pregnant or breastfeeding - You take high-dose benzodiazepines (the equivalent of more than 6 mg lorazepam per day) - You use herbal supplements like St. John's Wort - You have a history of uncontrolled seizures, severe uncontrolled high blood pressure, or certain heart or vascular conditions - You are currently using stimulants like methylphenidate or amphetamines (unless you can stop for the study) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEsketamine 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.


Locations(1)

Royal North Shore Hospital

St Leonards, New South Wales, Australia

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NCT06103760


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