ID

37443

Description

A Study to Evaluate the Efficacy, Safety, and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression; ODM derived from: https://clinicaltrials.gov/show/NCT02418585

Link

https://clinicaltrials.gov/show/NCT02418585

Keywords

Versions (1)
  1. 7/27/19 7/27/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 27, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Treatment-resistant Depression NCT02418585

English

Eligibility Treatment-resistant Depression NCT02418585

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
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
Description

Informed Consent | Age

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0001779
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)
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0024517
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C0743081
UMLS CUI [2,2]
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 - 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 -
Description

IDS-C | Antidepressant therapy Oral Quantity | Response Lacking

Data type

boolean

Alias
UMLS CUI [1]
C4330496
UMLS CUI [2,1]
C1096649
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C1704632
UMLS CUI [3,2]
C0332268
antidepressant treatment response questionnaire (mgh-atrq) and documented by medical history and pharmacy/prescription records, for the current episode of depression: subject must be taking an oral antidepressant treatment with nonresponse at the start of the screening/prospective observational phase
Description

Depressive episode Response to antidepressant Questionnaire | Depressive episode Medical History | Depressive episode Medicinal prescription record | Antidepressant therapy Oral | Response Lacking

Data type

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
UMLS CUI [4,1]
C1096649
UMLS CUI [4,2]
C1527415
UMLS CUI [5,1]
C1704632
UMLS CUI [5,2]
C0332268
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
Description

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

Data type

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
Exclusion Criteria
Description

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
Description

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

Data type

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
Description

Vagus Nerve Stimulation | Deep Brain Stimulation | Depressive episode

Data type

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
Description

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

Data type

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)
Description

Homicidal thoughts C-SSRS | Homicidal intent C-SSRS

Data type

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
Description

Substance Use Disorder Moderate | Substance Use Disorder Severe

Data type

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 NCT02418585

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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) to 64 years of age, inclusive
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 | Antidepressant therapy Oral Quantity | Response Lacking
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 - 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
C4330496 (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])
Depressive episode Response to antidepressant Questionnaire | Depressive episode Medical History | Depressive episode Medicinal prescription record | Antidepressant therapy Oral | Response Lacking
Item
antidepressant treatment response questionnaire (mgh-atrq) and documented by medical history and pharmacy/prescription records, for the current episode of depression: subject must be taking an oral antidepressant treatment with nonresponse at the start of the screening/prospective observational phase
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])
C1096649 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C1704632 (UMLS CUI [5,1])
C0332268 (UMLS CUI [5,2])
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
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])
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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