Study Subject Participation Status | Enrollment Direct
Item
a). for direct-entry participants
boolean
C2348568 (UMLS CUI [1])
C1516879 (UMLS CUI [2,1])
C1947931 (UMLS CUI [2,2])
Informed Consent | Age
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)
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 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])
MADRS | Antidepressant therapy Oral Quantity | Response Lacking | Study Subject Participation Status | Patients transferred
Item
at screening, participant must have a madrs total score of >=22 - at the start of the screening phase, participants must have had nonresponse to >=2 oral antidepressant treatments taken at adequate dosage and for adequate duration, as assessed using the massachusetts general hospital b). for transferred-entry participants
boolean
C4054475 (UMLS CUI [1])
C1096649 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1704632 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
C2348568 (UMLS CUI [4])
C0030704 (UMLS CUI [5])
Induction phase Specified Completed | Clinical Trial Eligibility Criteria Fulfill
Item
all participants who completed the double-blind induction phase of esketintrd3005 study, regardless of their response status, will be eligible to participate in this study, if they meet the study specific eligibility criteria
boolean
C4049995 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C1516637 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Study Subject Participation Status | Enrollment Direct
Item
a). for direct-entry participants
boolean
C2348568 (UMLS CUI [1])
C1516879 (UMLS CUI [2,1])
C1947931 (UMLS CUI [2,2])
Depressive Symptoms Response Lacking | Esketamine | Ketamine | Major depressive episode | Antidepressant therapy Oral Quantity | Induction phase Open Label | duloxetine | Escitalopram | Sertraline | Venlafaxine XR | Response to antidepressant Questionnaire
Item
participant's depressive symptoms have previously not responded to: 1).esketamine or ketamine in the current major depressive episode per clinical judgment, 2). all of the 4 oral antidepressant treatment options available in the respective country for the open-label induction phase (that is, duloxetine, escitalopram, sertraline, and venlafaxine xr) in the current major depressive episode (based on massachusetts general hospital - antidepressant treatment response questionnaire [ mgh-atrq])
boolean
C0086132 (UMLS CUI [1,1])
C1704632 (UMLS CUI [1,2])
C0332268 (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])
C1709323 (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])
Psychotic Disorders | Major Depressive Disorder with Psychotic Disorder | Bipolar Disorder | Disease Related | Obsessive-Compulsive Disorder | Intellectual Disability | Autism Spectrum Disorders | 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 (dsm-5 diagnostic codes 317, 318.0, 318.1, 318.2, 315.8, and 319), autism spectrum disorder, 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])
C1510586 (UMLS CUI [7])
C0006012 (UMLS CUI [8])
C0003431 (UMLS CUI [9])
C0019681 (UMLS CUI [10])
C0027402 (UMLS CUI [11])
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 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])
Age | Mini-mental state examination | Neurodegenerative Disorders | Alzheimer's Disease | Dementia, Vascular | Parkinson Disease | Mild cognitive disorder | Study Subject Participation Status | Patients transferred
Item
participants aged greater than or equal to 65 years: has a mini mental state examination (mmse) <25; has neurodegenerative disorder (example, alzheimer's disease, vascular dementia, parkinson's disease), or evidence of mild cognitive impairment (mci) b). transferred-entry participants
boolean
C0001779 (UMLS CUI [1])
C0451306 (UMLS CUI [2])
C0524851 (UMLS CUI [3])
C0002395 (UMLS CUI [4])
C0011269 (UMLS CUI [5])
C0030567 (UMLS CUI [6])
C1270972 (UMLS CUI [7])
C2348568 (UMLS CUI [8])
C0030704 (UMLS CUI [9])
Therapeutic procedure Illicit
Item
participant has taken any prohibited therapies that would not permit dosing on day 1
boolean
C0087111 (UMLS CUI [1,1])
C0332266 (UMLS CUI [1,2])