A Study of Esketamine Nasal Spray in Korean Participants With Treatment-resistant Depression

This open-label, single-arm Phase IV trial (n=47) will evaluate the efficacy and safety of esketamine nasal spray (flexibly dosed at 56mg or 84mg) in Korean adults with treatment-resistant depression (TRD).

Conducted by Janssen Korea, Ltd., this multicentre study focuses on adults aged 18 to 64 who have not responded to at least two prior antidepressant medications during their current episode of moderate to severe depression. Participants will self-administer esketamine nasal spray twice weekly for four weeks. Doses will be adjusted between 56 mg and 84 mg, depending on individual tolerance and treatment needs. The primary outcome will be assessed using the Hamilton Depression Rating Scale (HAM-D), which measures severity of depressive symptoms. Secondary outcomes include scores on patient-reported measures such as the PHQ-9 and clinician-administered assessments like the Clinical Global Impression-Severity (CGI-S) scale.

The aim is to determine how effective esketamine is in reducing depressive symptoms in a real-world clinical setting for Korean patients, and to gather safety and tolerability data specific to this population. The study will also monitor rates of remission and clinically meaningful improvement, potentially informing future regional and global treatment guidelines for esketamine use in depression that does not respond to conventional therapies.

Topic Depression Treatment-Resistant Depression
Compound Ketamine
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Trial Details



Trial Number

Sponsors & Collaborators

Johnson & Johnson
One of the largest pharmaceutical companies in the world, Johnson & Johnson are responsible for bringing esketamine to market in the form of Spravato.

Data attribution

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