A Double-blind Study to Assess the Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Participants Who Are Assessed to be at Imminent Risk for Suicide
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major; Suicide; Suicidal Ideation
Intervention: Esketamine; Placebo
Intervention description: Esketamine 84 mg will be self-administered by participants as intranasal spray as two times a week, for 4 weeks (that is, Day 1,4,8,11,15,18,22,25). Dose may be reduced to 56 mg per day based on Investigator's discretion.; Matching placebo will be self-administered by participants as intranasal spray as two times a week, for 4 weeks (that is, Day 1,4,8,11,15,18,22,25).
Intervention MeSH terms: Esketamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; Esketamine; Intranasal esketamine; Placebo

Summary:

      The purpose of this study is to evaluate the efficacy of intranasal esketamine 84 milligram
      (mg) compared with intranasal placebo along with standard care treatment, in reducing the
      symptoms of major depressive disorder (MDD) (an affective disorder manifested by either a
      dysphoric mood or loss of interest or pleasure in usual activities, the mood disturbance is
      prominent and relatively persistent), including the risk for suicide as assessed by the
      Investigator, in participants who will be assessed to be at imminent risk for suicide.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must meet Diagnostic and Statistical Manual of Mental Disorders, fourth
             edition (DSM-IV) diagnostic criteria for major depressive disorder

          -  Participants must have current suicidal ideation with intent

          -  In the Investigator's opinion, participant must be in need of acute psychiatric
             hospitalization due to imminent risk of suicide

          -  Participant has a Montgomery Asberg Depression Rating Scale (MADRS) total score of
             greater than or equal to (>=) 22 predose on Day 1

          -  As part of standard of care treatment, participant agrees to be hospitalized
             voluntarily for a recommended period of 5 days after randomization (that is, through
             Day 5), and take prescribed non-investigational antidepressant therapy(ies) for at
             least the duration of the double-blind treatment phase (Day 25)

        Exclusion Criteria:

          -  Participant has a current clinical diagnosis of bipolar or related disorders,
             intellectual disability, or cluster b personality disorder (example, borderline
             personality disorder, antisocial personality disorder, histrionic personality
             disorder, and narcissistic personality disorder)

          -  Participant meets DSM-IV criteria for borderline personality disorder, based on
             clinical interview

          -  Participant has a current or prior diagnosis of a psychotic disorder, major depressive
             disorder (MDD) with psychosis, or obsessive compulsive disorder

          -  Participant with a history or current signs and symptoms of liver or renal
             insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine,
             neurologic, hematologic, rheumatologic, or metabolic disturbances

          -  Participant has uncontrolled hypertension (systolic blood pressure greater than [>]
             160 millimeter of mercury [mmHg] or diastolic blood pressure > 90 mmHg) despite diet,
             exercise or a stable dose of an allowed anti-hypertensive treatment at Screening; or
             any past history of hypertensive crisis