Informed Consent | Age
Item
at the time of signing the informed consent form (icf), participant must be a man or woman 65 years of age or older
boolean
C0021430 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Major depressive episode Duration | DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE Recurrent
Item
at the start of the screening/prospective observational phase, participant must meet the diagnostic and statistical manual of mental disorders (dsm-5) diagnostic criteria for single-episode major depressive disorder (mdd) [if single-episode mdd, the duration must be greater than or equal to (>=) 2 years] or recurrent mdd, without psychotic features, based upon clinical assessment and confirmed by the mini-international neuropsychiatric interview (mini)
boolean
C0024517 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0743081 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
IDS-C
Item
at the start of the screening/prospective observational phase, participant must have an inventory of depressive symptomatology-clinician rated (ids-c30) total score of greater than or equal to (>=) 34
boolean
C4330496 (UMLS CUI [1])
Antidepressant therapy Oral Quantity | Response Lacking | Depressive episode Response to antidepressant Questionnaire | Depressive episode Medical History | Depressive episode Medicinal prescription record
Item
at the start of the screening/prospective observational phase, participants must have had nonresponse to >=2 but less than or equal to (<=) 5 oral antidepressant treatments taken at adequate dosage and for adequate duration, as assessed using the massachusetts general hospital - antidepressant treatment response questionnaire (mgh-atrq) and documented by medical history and pharmacy/prescription records, for the current episode of depression
boolean
C1096649 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1704632 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C0349217 (UMLS CUI [3,1])
C3549249 (UMLS CUI [3,2])
C0034394 (UMLS CUI [3,3])
C0349217 (UMLS CUI [4,1])
C0262926 (UMLS CUI [4,2])
C0349217 (UMLS CUI [5,1])
C4545845 (UMLS CUI [5,2])
Antidepressant therapy Oral | Response Lacking
Item
participant must be taking an oral antidepressant treatment and remain non-responsive to the oral antidepressant throughout the screening phase
boolean
C1096649 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1704632 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Major depressive episode | Response Antidepressant therapy | Depressive episode | Study Subject Participation Status Assessed
Item
the participant's current major depressive episode and treatment response to antidepressant treatments used in the current depressive episode (retrospectively assessed) must be confirmed for participation in a clinical study based on a site-independent qualification assessment
boolean
C0024517 (UMLS CUI [1])
C0871261 (UMLS CUI [2,1])
C1096649 (UMLS CUI [2,2])
C0349217 (UMLS CUI [3])
C2348568 (UMLS CUI [4,1])
C1516048 (UMLS CUI [4,2])
Patient's condition stable Medical Laboratory Procedures
Item
participant must be medically stable on the basis of clinical laboratory tests performed in the screening/prospective observational phase
boolean
C1282982 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,3])
Esketamine | Ketamine | Depressive disorder | Depressive Symptoms | Antidepressant therapy Oral Quantity | Response Lacking | Induction phase Double-Blind | duloxetine | Escitalopram | Sertraline | Venlafaxine XR | Major depressive episode | Response to antidepressant Questionnaire | Electroconvulsive Therapy | Unilateral electroconvulsive therapy Quantity
Item
any participant who have previously received esketamine or ketamine for depression and depressive symptoms have previously demonstrated nonresponse to all of the 4 oral antidepressant treatment options available for the double-blind induction phase (duloxetine, escitalopram, sertraline, and venlafaxine extended release [xr]) in the current major depressive episode (based on mgh-atrq), or an adequate course of treatment with electroconvulsive therapy (ect) in the current major depressive episode, defined as at least 7 treatments with unilateral ect
boolean
C2825616 (UMLS CUI [1])
C0022614 (UMLS CUI [2])
C0011581 (UMLS CUI [3])
C0086132 (UMLS CUI [4])
C1096649 (UMLS CUI [5,1])
C1527415 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
C1704632 (UMLS CUI [6,1])
C0332268 (UMLS CUI [6,2])
C4049995 (UMLS CUI [7,1])
C0013072 (UMLS CUI [7,2])
C0245561 (UMLS CUI [8])
C1099456 (UMLS CUI [9])
C0074393 (UMLS CUI [10])
C0078569 (UMLS CUI [11,1])
C1707968 (UMLS CUI [11,2])
C0024517 (UMLS CUI [12])
C3549249 (UMLS CUI [13,1])
C0034394 (UMLS CUI [13,2])
C0013806 (UMLS CUI [14])
C0562344 (UMLS CUI [15,1])
C1265611 (UMLS CUI [15,2])
Vagus Nerve Stimulation | Deep Brain Stimulation | Depressive episode
Item
participants who currently have an implant for vagal nerve stimulation (vns) or who received deep brain stimulation (dbs) in the current episode of depression
boolean
C2350432 (UMLS CUI [1])
C0394162 (UMLS CUI [2])
C0349217 (UMLS CUI [3])
Psychotic Disorders | Major Depressive Disorder with Psychotic Disorder | Bipolar Disorder | Disease Related | Obsessive-Compulsive Disorder | Intellectual Disability | Borderline Personality Disorder | Antisocial Personality Disorder | Histrionic Personality Disorder | Narcissistic Personality Disorder
Item
participant has a current or prior dsm-5 diagnosis of a psychotic disorder or mdd with psychosis, bipolar or related disorders (confirmed by the mini), comorbid obsessive compulsive disorder, intellectual disability ( intellectual disability [dsm-5 diagnostic codes 317, 318.0, 318.1, 318.2, 315.8, and 319]), borderline personality disorder, antisocial personality disorder, histrionic personality disorder, or narcissistic personality disorder
boolean
C0033975 (UMLS CUI [1])
C1269683 (UMLS CUI [2,1])
C0332287 (UMLS CUI [2,2])
C0033975 (UMLS CUI [2,3])
C0005586 (UMLS CUI [3])
C0012634 (UMLS CUI [4,1])
C0439849 (UMLS CUI [4,2])
C0028768 (UMLS CUI [5])
C3714756 (UMLS CUI [6])
C0006012 (UMLS CUI [7])
C0003431 (UMLS CUI [8])
C0019681 (UMLS CUI [9])
C0027402 (UMLS CUI [10])
Homicidal thoughts C-SSRS | Homicidal intent C-SSRS | Suicidal behavior
Item
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/prospective observational phase, per the investigator's clinical judgment or based on the columbia suicide severity rating scale (c-ssrs) and also includes history of suicidal behavior within the past year prior to start of the screening/prospective observational phase
boolean
C0455204 (UMLS CUI [1,1])
C3888485 (UMLS CUI [1,2])
C2046965 (UMLS CUI [2,1])
C3888485 (UMLS CUI [2,2])
C1760428 (UMLS CUI [3])
Ketamine | Phencyclidine | Lysergic Acid Diethylamide | MDMA | Disease Hallucinogen use Related
Item
participant has a history (lifetime) of ketamine, phencyclidine (pcp), lysergic acid diethylamide (lsd), or 3, 4-methylenedioxy-methamphetamine (mdma) hallucinogen-related use disorder\
boolean
C0022614 (UMLS CUI [1])
C0031381 (UMLS CUI [2])
C0024334 (UMLS CUI [3])
C0115471 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C0239807 (UMLS CUI [5,2])
C0439849 (UMLS CUI [5,3])
Mini-mental state examination
Item
participant has a mini mental state examination (mmse) less than (<) 25
boolean
C0451306 (UMLS CUI [1])
Neurodegenerative Disorders | Alzheimer's Disease | Dementia, Vascular | Parkinson Disease | Mild cognitive disorder
Item
participant has neurodegenerative disorder (eg, alzheimer's disease, vascular dementia, parkinson's disease) or evidence of mild cognitive impairment (mci)
boolean
C0524851 (UMLS CUI [1])
C0002395 (UMLS CUI [2])
C0011269 (UMLS CUI [3])
C0030567 (UMLS CUI [4])
C1270972 (UMLS CUI [5])
Uncontrolled hypertension | Lung insufficiency | Electrocardiogram abnormal | Seizures | Cardiovascular Diseases | Cerebrovascular Disorders
Item
participant has a history of uncontrolled hypertension; current or past history of significant pulmonary insufficiency/condition;clinically significant ecg abnormalities; current or past history of seizures; clinically significant cardiovascular disorders including cerebral and cardiac vascular disease
boolean
C1868885 (UMLS CUI [1])
C1401064 (UMLS CUI [2])
C0522055 (UMLS CUI [3])
C0036572 (UMLS CUI [4])
C0007222 (UMLS CUI [5])
C0007820 (UMLS CUI [6])