ID

37444

Description

A Study to Evaluate the Efficacy, Safety, and Tolerability of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Participants With Treatment-resistant Depression; ODM derived from: https://clinicaltrials.gov/show/NCT02422186

Lien

https://clinicaltrials.gov/show/NCT02422186

Mots-clés

Versions (1)
  1. 27/07/2019 27/07/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

27 juillet 2019

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Treatment-resistant Depression NCT02422186

Anglais

Eligibility Treatment-resistant Depression NCT02422186

1 Formulaires  
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 65 years of age or older
Description

Informed Consent | Age

Type de données

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

Type de données

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
Description

IDS-C

Type de données

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 - antidepressant treatment response questionnaire (mgh-atrq) and documented by medical history and pharmacy/prescription records, for the current episode of depression
Description

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

Type de données

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
UMLS CUI [3,1]
C0349217
UMLS CUI [3,2]
C3549249
UMLS CUI [3,3]
C0034394
UMLS CUI [4,1]
C0349217
UMLS CUI [4,2]
C0262926
UMLS CUI [5,1]
C0349217
UMLS CUI [5,2]
C4545845
participant must be taking an oral antidepressant treatment and remain non-responsive to the oral antidepressant throughout the screening phase
Description

Antidepressant therapy Oral | Response Lacking

Type de données

boolean

Alias
UMLS CUI [1,1]
C1096649
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0332268
the participant's current major depressive episode and treatment response to antidepressant treatments used in the current depressive episode (retrospectively assessed) must be confirmed 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

Type de données

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
participant must be medically stable on the basis of clinical laboratory tests performed in the screening/prospective observational phase
Description

Patient's condition stable Medical Laboratory Procedures

Type de données

boolean

Alias
UMLS CUI [1,1]
C1282982
UMLS CUI [1,2]
C0205476
UMLS CUI [1,3]
C0022885
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
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
Description

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

Type de données

boolean

Alias
UMLS CUI [1]
C2825616
UMLS CUI [2]
C0022614
UMLS CUI [3]
C0011581
UMLS CUI [4]
C0086132
UMLS CUI [5,1]
C1096649
UMLS CUI [5,2]
C1527415
UMLS CUI [5,3]
C1265611
UMLS CUI [6,1]
C1704632
UMLS CUI [6,2]
C0332268
UMLS CUI [7,1]
C4049995
UMLS CUI [7,2]
C0013072
UMLS CUI [8]
C0245561
UMLS CUI [9]
C1099456
UMLS CUI [10]
C0074393
UMLS CUI [11,1]
C0078569
UMLS CUI [11,2]
C1707968
UMLS CUI [12]
C0024517
UMLS CUI [13,1]
C3549249
UMLS CUI [13,2]
C0034394
UMLS CUI [14]
C0013806
UMLS CUI [15,1]
C0562344
UMLS CUI [15,2]
C1265611
participants who currently have an implant for vagal nerve stimulation (vns) or who received deep brain stimulation (dbs) in the current episode of depression
Description

Vagus Nerve Stimulation | Deep Brain Stimulation | Depressive episode

Type de données

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 ( 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
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

Type de données

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) and also includes history of suicidal behavior within the past year prior to start of the screening/prospective observational phase
Description

Homicidal thoughts C-SSRS | Homicidal intent C-SSRS | Suicidal behavior

Type de données

boolean

Alias
UMLS CUI [1,1]
C0455204
UMLS CUI [1,2]
C3888485
UMLS CUI [2,1]
C2046965
UMLS CUI [2,2]
C3888485
UMLS CUI [3]
C1760428
participant has a history (lifetime) of ketamine, phencyclidine (pcp), lysergic acid diethylamide (lsd), or 3, 4-methylenedioxy-methamphetamine (mdma) hallucinogen-related use disorder\
Description

Ketamine | Phencyclidine | Lysergic Acid Diethylamide | MDMA | Disease Hallucinogen use Related

Type de données

boolean

Alias
UMLS CUI [1]
C0022614
UMLS CUI [2]
C0031381
UMLS CUI [3]
C0024334
UMLS CUI [4]
C0115471
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0239807
UMLS CUI [5,3]
C0439849
participant has a mini mental state examination (mmse) less than (<) 25
Description

Mini-mental state examination

Type de données

boolean

Alias
UMLS CUI [1]
C0451306
participant has neurodegenerative disorder (eg, alzheimer's disease, vascular dementia, parkinson's disease) or evidence of mild cognitive impairment (mci)
Description

Neurodegenerative Disorders | Alzheimer's Disease | Dementia, Vascular | Parkinson Disease | Mild cognitive disorder

Type de données

boolean

Alias
UMLS CUI [1]
C0524851
UMLS CUI [2]
C0002395
UMLS CUI [3]
C0011269
UMLS CUI [4]
C0030567
UMLS CUI [5]
C1270972
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
Description

Uncontrolled hypertension | Lung insufficiency | Electrocardiogram abnormal | Seizures | Cardiovascular Diseases | Cerebrovascular Disorders

Type de données

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C1401064
UMLS CUI [3]
C0522055
UMLS CUI [4]
C0036572
UMLS CUI [5]
C0007222
UMLS CUI [6]
C0007820
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Similar models

Eligibility Treatment-resistant Depression NCT02422186

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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 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])
Item Group
C0680251 (UMLS CUI)
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])
Retour au début de la page 

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