Clinical TrialTreatment-Resistant Depression (TRD)EsketamineEsketamineRecruiting

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).

Target Enrollment
47 participants
Study Type
Phase IV interventional
Design
Non-randomized

Detailed Description

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.

Study Protocol

Preparation

sessions

Dosing

8 sessions

Integration

sessions

Study Arms & Interventions

Esketamine Nasal Spray

experimental

Flexible-dose intranasal esketamine (56 mg or 84 mg) administered twice weekly for 4 weeks (single-group design).

Interventions

  • Esketamine56 mg
    via Other• twice weekly for 4 weeks• 8 doses total

    56 mg delivered using 2 devices (one spray per nostril).

  • Esketamine84 mg
    via Other• twice weekly for 4 weeks• 8 doses total

    84 mg delivered using 3 devices (rapid succession) per dosing session.

Participants

Ages
18 – 64
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:\n\n* Must have a confirmed diagnosis of major depressive disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition at the time of enrollment, without psychotic features, based on clinical assessment, and confirmed by mini international neuropsychiatric interview (MINI)\n* Must have a Hamilton depression rating scale (HAM-D; 17-item) total score greater than or equal to (>=) 22 at screening and Day 1\n* Participants must have had non-response (less than or equal to (<=) 25 percent [%] improvement of symptoms) to >= 2 oral antidepressant treatments in the current moderate to severe episode of depression after having been given at an adequate dosage for an adequate duration of at least 6 weeks\n* At baseline (Day 1), the investigator will evaluate any changes in the participant's signs/symptoms of depression since the screening assessment and confirm that the inclusion criteria for the current antidepressant (AD) treatment are still met (that is, nonresponse and minimal clinical improvement)\n* A female participant of childbearing potential must have a negative serum pregnancy test at screening and urine prior to the first dose of study intervention on Day 1

Exclusion Criteria

  • Exclusion Criteria:\n\n* Participants with hyperthyroidism that has not been sufficiently treated\n* History of malignancy within 5 years of enrollment before screening\n* Known allergies, hypersensitivity, or intolerance to esketamine/ketamine or its excipients\n* Received an investigational intervention or used an invasive investigational medical device within 60 days before the planned first dose of study intervention or first data collection time point\n* Currently enrolled in an investigational study that involves treatments for MDD or may otherwise be expected to impact mood

Study Details

Locations

Cha Ilsan Medical Center — Goyang Si Gyeonggi Do, South Korea
Wonkwang University Hospital — Iksan, South Korea
Kangbuk Samsung Hospital — Seoul, South Korea
Asan Medical Center — Seoul, South Korea
Samsung Medical Center — Seoul, South Korea
Kyung Hee University Hospital — Seoul, South Korea

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