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

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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).

Details

This single-group, open-label Phase IV study will administer intranasal esketamine (56 mg or 84 mg) twice weekly for 4 weeks to adults with treatment-resistant major depressive disorder to assess symptom change.

Primary outcome is change from baseline in the 17-item Hamilton Depression Rating Scale (HAM-D) total score from Day 1 to Day 28; safety and tolerability will be monitored throughout the treatment and follow-up periods.

Topics:Treatment-Resistant Depression (TRD)

Registry

Registry linkNCT07053345