Phase
Condition
Affective Disorders
Depression
Depression (Major/severe)
Treatment
Esketamine
Placebo
Clinical Study ID
Ages 18-64 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must meet Diagnostic and Statistical Manual of Mental Disorders, fourthedition (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 psychiatrichospitalization due to imminent risk of suicide
Participant has a Montgomery Asberg Depression Rating Scale (MADRS) total score ofgreater than or equal to (>=) 22 predose on Day 1
As part of standard of care treatment, participant agrees to be hospitalizedvoluntarily for a recommended period of 5 days after randomization (that is, throughDay 5), and take prescribed non-investigational antidepressant therapy(ies) for atleast the duration of the double-blind treatment phase (Day 25)
Exclusion
Exclusion Criteria:
Participant has a current clinical diagnosis of bipolar or related disorders,intellectual disability, or cluster b personality disorder (example, borderlinepersonality disorder, antisocial personality disorder, histrionic personalitydisorder, and narcissistic personality disorder)
Participant meets DSM-IV criteria for borderline personality disorder, based onclinical interview
Participant has a current or prior diagnosis of a psychotic disorder, majordepressive disorder (MDD) with psychosis, or obsessive compulsive disorder
Participant with a history or current signs and symptoms of liver or renalinsufficiency; 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) despitediet, exercise or a stable dose of an allowed anti-hypertensive treatment atScreening; or any past history of hypertensive crisis
Study Design
Study Description
Connect with a study center
Birmingham, Alabama
United StatesSite Not Available
San Diego, California
United StatesSite Not Available
Hartford, Connecticut
United StatesSite Not Available
New Haven, Connecticut
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Atlanta, Georgia
United StatesSite Not Available
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Augusta, Georgia
United StatesSite Not Available
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Skokie, Illinois
United StatesSite Not Available
Iowa City, Iowa
United StatesSite Not Available
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Louisville, Kentucky
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Baltimore, Maryland
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Towson, Maryland
United StatesSite Not Available
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Boston, Massachusetts
United StatesSite Not Available
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Worcester, Massachusetts
United StatesSite Not Available
Ann Arbor, Michigan
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Rochester, Minnesota
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New York, New York
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Durham, North Carolina
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Cincinnati, Ohio
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Philadelphia, Pennsylvania
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Pittsburgh, Pennsylvania
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Charleston, South Carolina
United StatesSite Not Available
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Dallas, Texas
United StatesSite Not Available
Houston, Texas
United StatesSite Not Available

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