Study Subject Participation Status | Enrollment Direct
Item
for direct-entry participants
boolean
C2348568 (UMLS CUI [1])
C1516879 (UMLS CUI [2,1])
C1947931 (UMLS CUI [2,2])
Informed Consent | Age | Major depressive episode Duration | DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE Recurrent
Item
at the time of signing the informed consent form (icf), participant must be a man or woman 18 (or older if the minimum legal age of consent in the country in which the study is taking place is greater than [>]18) to 64 years of age, inclusive - 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
C0021430 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0024517 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
C0743081 (UMLS CUI [4,1])
C2945760 (UMLS CUI [4,2])
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
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
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])
Depressive episode Response to antidepressant Questionnaire | Depressive episode Medical History | Depressive episode Medicinal prescription record
Item
antidepressant treatment response questionnaire (mgh-atrq) and documented by medical history and pharmacy/prescription records, for the current episode of depression
boolean
C0349217 (UMLS CUI [1,1])
C3549249 (UMLS CUI [1,2])
C0034394 (UMLS CUI [1,3])
C0349217 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0349217 (UMLS CUI [3,1])
C4545845 (UMLS CUI [3,2])
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 deemed valid for participation in a clinical study based on a site-independent qualification assessment for transferred-entry participants
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])
Induction phase Specified Completed | Disease Response | Montgomery-Asberg Depression Rating Scale Questionnaire
Item
the participant must have completed the double-blind induction phase in esketintrd3001 or esketintrd3002 and must have demonstrated response at the end of that phase (>=50% reduction in the madrs total score from baseline [day 1 pre-randomization] at the end of the 4-week double-blind induction phase)
boolean
C4049995 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C1704632 (UMLS CUI [2])
C4054475 (UMLS CUI [3])
Response Lacking Depressive Symptoms | Esketamine | Ketamine | Major depressive episode | Antidepressant therapy Oral Quantity | Induction phase Double-Blind | duloxetine | Escitalopram | Sertraline | Venlafaxine XR | Response to antidepressant Questionnaire | Electroconvulsive Therapy | Unilateral electroconvulsive therapy Quantity
Item
participants who have previously demonstrated nonresponse of depressive symptoms to esketamine or ketamine in the current major depressive episode, to all 4 of the oral antidepressant treatment options available for the double-blind induction phase (ie, 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
C1704632 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0086132 (UMLS CUI [1,3])
C2825616 (UMLS CUI [2])
C0022614 (UMLS CUI [3])
C0024517 (UMLS CUI [4])
C1096649 (UMLS CUI [5,1])
C1527415 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
C4049995 (UMLS CUI [6,1])
C0013072 (UMLS CUI [6,2])
C0245561 (UMLS CUI [7])
C1099456 (UMLS CUI [8])
C0074393 (UMLS CUI [9])
C0078569 (UMLS CUI [10,1])
C1707968 (UMLS CUI [10,2])
C3549249 (UMLS CUI [11,1])
C0034394 (UMLS CUI [11,2])
C0013806 (UMLS CUI [12])
C0562344 (UMLS CUI [13,1])
C1265611 (UMLS CUI [13,2])
Vagus Nerve Stimulation | Deep Brain Stimulation | Depressive episode
Item
participant currently has an implant for vagal nerve stimulation (vns) or has 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 (only dsm-5 diagnostic code 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
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)
boolean
C0455204 (UMLS CUI [1,1])
C3888485 (UMLS CUI [1,2])
C2046965 (UMLS CUI [2,1])
C3888485 (UMLS CUI [2,2])
Substance Use Disorder Moderate | Substance Use Disorder Severe
Item
participants with history of moderate or severe substance or alcohol use disorder according to dsm-5 criteria
boolean
C0038586 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0038586 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])