RecruitingPhase 4

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

Australia162 participantsStarted 2023-10-31

Plain-language 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

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Adults aged 18-65 years old
. Diagnosis of Major Depressive Disorder (MDD)
. Currently depressed
. Had an inadequate response to 2 or more courses of antidepressants (of adequate dose and duration)
. Be maintained on their current antidepressant medication or psychological therapy at the time of enmrolment
. Able to understand and provide informed consent

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of treatment responders determined by a 50% reduction on the Hamilton Depression Rating Scale (HAM-D) 17-Item scoring.

Timeframe: At the end of week 4

Mean depression score on the Quick Inventory of Depressive Symptomatology Self-report (QIDS-SR) 16-Item.

Timeframe: 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.

Timeframe: Baseline, week 1, week 2, week 3, week 4 (primary time point), week 8 and week 12 after Esketamine was commenced.

Trial details

NCT IDNCT06103760

SponsorRoyal North Shore Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-15

Contact for this trial

Erica Bell

02 9462 9905 NSLHD-researchpoet@health.nsw.gov.au

View on ClinicalTrials.gov More Major Depressive Disorder trials