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NCT06103760: PoET
Positioning of Esketamine Treatment in the Real-world Management of Depression
Phase 4 trial testing Esketamine Nasal Spray [Spravato] in Major Depressive Disorder in 162 participants. Currently enrolling.
15 September 2025
Quick facts
| Lead sponsor | Royal North Shore Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 162 |
| Start date | 31 October 2023 |
| Primary completion | 15 September 2025 |
| Estimated completion | 15 January 2026 |
| Sites | 1 location across Australia |
Drugs / interventions tested
- Esketamine Nasal Spray [Spravato] — full drug profile →
Conditions studied
- Major Depressive Disorder — all drugs for Major Depressive Disorder →
Sponsor
Royal North Shore Hospital
Who can join
Adults 18 to 65, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06103760
- Europe PMC full search
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Other Royal North Shore Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06103760 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Royal North Shore Hospital
- Last refreshed: 17 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06103760.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing