Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Adult Subjects Assessed to be at Imminent Risk for Suicide
Brief Summary: The purpose of this study is to evaluate the efficacy of intranasal esketamine 84 milligram (mg) compared with intranasal placebo in addition to comprehensive standard of care in reducing the symptoms of Major Depressive Disorder (MDD), including suicidal ideation, in participants who are 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 24 hours post first dose.


Options:
A: Inclusion Criteria:

* Participant must meet Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) diagnostic criteria for major depressive disorder (MDD), without psychotic features, based upon clinical assessment and confirmed by the Mini International Psychiatric Interview (MINI)
* Participants must have current suicidal ideation with intent, confirmed by a "Yes" response to Question B3 \[Think (even momentarily) about harming or of hurting or of injuring yourself: with at least some intent or awareness that you might die as a result; or think about suicide (ie, about killing yourself)?\] AND Question B10 \[Intend to act on thoughts of killing yourself?\] obtained from the MINI
* In the physician's opinion, acute psychiatric hospitalization is clinically warranted due to participant's imminent risk of suicide
* Participant has a Montgomery Asberg Depression Rating Scale (MADRS) total score of greater than (\>) 28 predose on Day 1
* As part of standard of care treatment, participant agrees to be hospitalized voluntarily for a recommended period of 14 days after randomization (may be shorter or longer if clinically warranted in the investigator's opinion) 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 DSM-5 diagnosis of bipolar (or related disorders), antisocial personality disorder, or obsessive compulsive disorder
* Participant currently meets DSM-5 criteria for borderline personality disorder. Note: Participant not meeting full DSM-5 criteria for borderline personality disorder but exhibiting recurrent suicidal gestures, threats, or self-mutilating behaviors should also be excluded
* Participant has a current clinical diagnosis of autism, dementia, or intellectual disability
* Participant has a current or prior DSM-5 diagnosis of a psychotic disorder, or MDD with psychotic features
* Participant meets the DSM-5 severity criteria for moderate or severe substance or alcohol use disorder, (except for nicotine or caffeine), within the 12 months before Screening. A history (lifetime) of ketamine, phencyclidine (PCP), lysergic acid diethylamide (LSD), or 3, 4-methylenedioxy-methamphetamine (MDMA) hallucinogen-related use disorder is exclusionary
* Participant has a history or current signs and symptoms of liver or renal insufficiency, clinically significant cardiac (including unstable coronary artery disease and congestive heart failure, tachyarrhythmias and recent myocardial infarction) or vascular, pulmonary, gastrointestinal, endocrine (including uncontrolled hyperthyroidism), neurologic (including current or past history of seizures except uncomplicated childhood febrile seizures with no sequelae), hematologic, rheumatologic, or metabolic (including severe dehydration/ hypovolemia) disease
* Participant has known allergies, hypersensitivity, intolerance or contraindications to esketamine or ketamine or its excipients
B: Inclusion Criteria:

* Adult patients, 18-65 years of age
* Major depression disorder without psychotic features
* Inadequate response to current, ongoing antidepressant treatment as defined by protocol
* Having at least one but no more than 2 antidepressant treatment trial failures
* Body mass index (BMI) 18.0-35.0 kg/m2 inclusive

Exclusion Criteria:

* Patient currently receives treatment with a combination of 3 or more antidepressants
* Significant ongoing use of high doses of barbiturates, benzodiazepines or other anxiolytic drugs
* Patient previously received RO4995819
* Patient participated in an investigational drug or device trial within 6 months of screening
* History of non-response to, or current use of non-pharmacological treatment including Electroconvulsive Therapy (ECT), Vagus Nerve Stimulation (VNS), or Repetitive Transcranial Magnetic Stimulation (RTMS)
* Past or present psychotic symptoms
C: Inclusion Criteria:

* Aged 18-55 years
* Fulfilled the DSM-IV criteria of major depressive disorder
* Had a 17-item Hamilton Rating Scale for Depression (HAMD-17)\>or= 18
* No DSM-IV diagnosis of substance abuse or dependence (including alcohol) within the past 6 months
* Had been drug free for \> 3 months
* Physically healthy and had all laboratory parameters within normal limits.
* Agree to participate in the study and provide informed consent

Exclusion Criteria:

* Had history of epilepsy, head trauma or other major neurological or medical diseases
* Had psychotic depression, bipolar I/II disorder, schizophrenia or any other psychotic disorder
* Moderate-severe suicidal risks
* Severe cognitive impairment
* Female subjects who were pregnant, or at risk of pregnancy or lactation
* Initiating or stopping formal psychotherapy within six weeks prior to enrollment
* Had a history of poor response to SSRIs or previously received electroconvulsive therapy
* Had a history of severe adverse reaction to SSRIs.
D: Inclusion Criteria:

* Adult patient, 18 to 70 years of age at time of informed consent
* Major depressive disorder without psychotic features as defined by DSM-IV-TR criteria
* Inadequate response to ongoing antidepressant treatment, as defined by protocol
* Body mass index (BMI) 18 to 38 kg/m2 inclusive

Exclusion Criteria:

* Currently receiving treatment with a combination of antidepressants (two or more), or an adjunctive potentiating treatment as defined by protocol
* Previously received RO4917523
* History of failure, or utilization during the current episode of Electroconvulsive Therapy (ECT) or repetitive Transcranial Magnetic Stimulation (rTMS)
* History of use at any time of Vagus Nerve Stimulation (VNS) or Deep Brain Stimulation (DBS)
* Current or past history of bipolar disorder (e.g. manic, hypomanic, or mixed episodes)
* Pregnant or lactating women

Answer: A