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

This is a randomized (study medication assigned to participants by chance), double-blind
(neither physician nor participant knows assigned study treatment), placebo-controlled
(participants are randomly assigned to a test treatment or to an identical-appearing
treatment that does not contain the test drug), and multicenter (when more than one hospital
or medical school team works on a medical research study), study of esketamine in
participants with major depressive disorder (MDD) in participants who will be assessed to be
at imminent risk for suicide, as measured by the change from Baseline on the
Montgomery-Asberg Depression Rating Scale (MADRS) total score at 4 hours postdose on Day 1.
The duration of study will be approximately 81 days per participant. The study consists of 3
parts: Screening (that is, with in 1 day before study commences on Day 1) and double-blind
Treatment (from Day 1-25) and Follow-up (from Day 26 up to Day 81). All the eligible
participants will be provided standard care treatment and will be randomly assigned to
either esketmaine or placebo treatment. Esketamine/placebo will be administered by
intranasal route (delivery of medications through the nasal mucosa) two times per week for 4
weeks. Efficacy of the participants will be primarily evaluated through MADRS. Participants'
safety will be monitored throughout the study.

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