A Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Doses of Intranasal Esketamine in Japanese Participants With Treatment Resistant Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Intervention: Placebo; Intranasal esketamine (28 mg); Intranasal esketamine (56 mg); Intranasal esketamine (84 mg)
Intervention description: Participant will receive 1 spray of placebo to each nostril at 0 minute, 5 minutes and 10 minutes.; Participant will receive 1 spray of Esketamine to each nostril at 0 minute and placebo at 5 minutes and 10 minutes.; Participant will receive 1 spray of Esketamine to each nostril at 0 minute, 5 minutes and placebo at 10 minutes.; Participant will receive 1 spray of Esketamine to each nostril at 0 minute, 5 minutes and 10 minutes.
Intervention MeSH terms: Esketamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 202.0
Sex: All
Minimum age: 20 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy of fixed dosed intranasal esketamine
      compared to intranasal placebo, as an add-on to an oral antidepressant in Japanese
      participants with treatment-resistant depression (TRD), in improving depressive symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At the start of the screening phase, participant must meet the Diagnostic and
             Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for single-episode
             major depressive disorder (MDD) or recurrent major depressive disorder (MDD), without
             psychotic features, based upon clinical assessment and confirmed by the Mini
             International Neuropsychiatric Interview (MINI). In the case of single-episode MDD,
             the participant must be diagnosed with persistent depressive disorder, which meets
             criteria of major depressive episode for a continuous duration of greater than or
             equal to (>=)2 years, and the same physician from the site must be examining the
             participant for >=2 years continuously as a primary care physician of the participant

          -  The participant's current major depressive episode, depression symptom severity (MADRS
             total score greater than or equal to [>=] 28 required), and antidepressant treatment
             response in the current depressive episode, must be confirmed using the SAFER
             interview

          -  Participant must be medically stable on the basis of clinical laboratory tests,
             physical examination, medical history, vital signs (including blood pressure), pulse
             oximetry, and 12-lead electrocardiogram (ECG) performed in the screening phase

          -  A woman of childbearing potential must have a negative highly sensitive serum Beta (β)
             human chorionic gonadotropin [β-hCG] test at the start of the screening phase and a
             negative urine pregnancy test must be obtained before the first dose of study drug on
             Day 1 of the double-blind induction phase prior to randomization

          -  Contraceptive use by men or women should be consistent with local regulations
             regarding the use of contraceptive methods for participant participating in clinical
             studies

        Exclusion Criteria:

          -  Participant has received vagal nerve stimulation or has received deep brain
             stimulation in the current episode of depression

          -  Participant previously received esketamine or ketamine as treatment for their MDD

          -  Participant has homicidal ideation/intent, per the investigator's clinical judgment,
             or has suicidal ideation with some intent to act within 6 months prior to the start of
             the screening phase

          -  Participant has a history of moderate or severe substance or alcohol use disorder
             according to DSM-5 criteria, except nicotine or caffeine, within 6 months before the
             start of the screening phase

          -  Participant has a current or past history of seizure disorder (uncomplicated childhood
             febrile seizures with no sequelae are not exclusionary)