Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingPhase 4interventionalRules rewrite

Phase 4: testing Esketamine Nasal Spray [Spravato] for Major Depressive Disorder

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 see if 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

Official registry: https://clinicaltrials.gov/study/NCT06103760 · Royal North Shore Hospital · enrollment listed as 162

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Esketamine Nasal Spray [Spravato]. The registry lists allocation as na. 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 see if 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

They plan to enroll about 162 people at St Leonards. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: Esketamine Nasal Spray [Spravato]

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

Who it is for (from inclusion criteria)

  • Ages 18 Years to 65 Years
  • Adults aged 18-65 years old
  • Diagnosis of Major Depressive Disorder (major depression)
  • 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

Public study contact (from the registry)

Erica Bell

02 9462 9905

NSLHD-researchpoet@health.nsw.gov.au

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT06103760 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06103760?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06103760?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary