ID

37446

Descripción

A Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Adult Participants With Treatment-resistant Depression; ODM derived from: https://clinicaltrials.gov/show/NCT02493868

Link

https://clinicaltrials.gov/show/NCT02493868

Palabras clave

Versiones (1)
  1. 27/7/19 27/7/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

27 de julio de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Treatment-resistant Depression NCT02493868

Inglés

Eligibility Treatment-resistant Depression NCT02493868

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
for direct-entry participants
Descripción

Study Subject Participation Status | Enrollment Direct

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1516879
UMLS CUI [2,2]
C1947931
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)
Descripción

Informed Consent | Age | Major depressive episode Duration | DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE Recurrent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0024517
UMLS CUI [3,2]
C0449238
UMLS CUI [4,1]
C0743081
UMLS CUI [4,2]
C2945760
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
Descripción

IDS-C

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4330496
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
Descripción

Antidepressant therapy Oral Quantity | Response Lacking

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1096649
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0332268
antidepressant treatment response questionnaire (mgh-atrq) and documented by medical history and pharmacy/prescription records, for the current episode of depression
Descripción

Depressive episode Response to antidepressant Questionnaire | Depressive episode Medical History | Depressive episode Medicinal prescription record

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0349217
UMLS CUI [1,2]
C3549249
UMLS CUI [1,3]
C0034394
UMLS CUI [2,1]
C0349217
UMLS CUI [2,2]
C0262926
UMLS CUI [3,1]
C0349217
UMLS CUI [3,2]
C4545845
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
Descripción

Major depressive episode | Response Antidepressant therapy | Depressive episode | Study Subject Participation Status Assessed

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0024517
UMLS CUI [2,1]
C0871261
UMLS CUI [2,2]
C1096649
UMLS CUI [3]
C0349217
UMLS CUI [4,1]
C2348568
UMLS CUI [4,2]
C1516048
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)
Descripción

Induction phase Specified Completed | Disease Response | Montgomery-Asberg Depression Rating Scale Questionnaire

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4049995
UMLS CUI [1,2]
C0205369
UMLS CUI [1,3]
C0205197
UMLS CUI [2]
C1704632
UMLS CUI [3]
C4054475
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
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
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1704632
UMLS CUI [1,2]
C0332268
UMLS CUI [1,3]
C0086132
UMLS CUI [2]
C2825616
UMLS CUI [3]
C0022614
UMLS CUI [4]
C0024517
UMLS CUI [5,1]
C1096649
UMLS CUI [5,2]
C1527415
UMLS CUI [5,3]
C1265611
UMLS CUI [6,1]
C4049995
UMLS CUI [6,2]
C0013072
UMLS CUI [7]
C0245561
UMLS CUI [8]
C1099456
UMLS CUI [9]
C0074393
UMLS CUI [10,1]
C0078569
UMLS CUI [10,2]
C1707968
UMLS CUI [11,1]
C3549249
UMLS CUI [11,2]
C0034394
UMLS CUI [12]
C0013806
UMLS CUI [13,1]
C0562344
UMLS CUI [13,2]
C1265611
participant currently has an implant for vagal nerve stimulation (vns) or has received deep brain stimulation (dbs) in the current episode of depression -
Descripción

Vagus Nerve Stimulation | Deep Brain Stimulation | Depressive episode

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2350432
UMLS CUI [2]
C0394162
UMLS CUI [3]
C0349217
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
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0033975
UMLS CUI [2,1]
C1269683
UMLS CUI [2,2]
C0332287
UMLS CUI [2,3]
C0033975
UMLS CUI [3]
C0005586
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0439849
UMLS CUI [5]
C0028768
UMLS CUI [6]
C3714756
UMLS CUI [7]
C0006012
UMLS CUI [8]
C0003431
UMLS CUI [9]
C0019681
UMLS CUI [10]
C0027402
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)
Descripción

Homicidal thoughts C-SSRS | Homicidal intent C-SSRS

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0455204
UMLS CUI [1,2]
C3888485
UMLS CUI [2,1]
C2046965
UMLS CUI [2,2]
C3888485
participants with history of moderate or severe substance or alcohol use disorder according to dsm-5 criteria
Descripción

Substance Use Disorder Moderate | Substance Use Disorder Severe

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0038586
UMLS CUI [2,2]
C0205082
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Similar models

Eligibility Treatment-resistant Depression NCT02493868

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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