ID

37447

Beschreibung

A Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression; ODM derived from: https://clinicaltrials.gov/show/NCT02497287

Link

https://clinicaltrials.gov/show/NCT02497287

Stichworte

Versionen (1)
  1. 27.07.19 27.07.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

27. Juli 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Treatment-resistant Depression NCT02497287

Englisch

Eligibility Treatment-resistant Depression NCT02497287

1 Formulare  
Criteria
Beschreibung

Criteria

a). for direct-entry participants
Beschreibung

Study Subject Participation Status | Enrollment Direct

Datentyp

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)
Beschreibung

Informed Consent | Age

Datentyp

boolean

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

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024517
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C0743081
UMLS CUI [2,2]
C2945760
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
Beschreibung

MADRS | Antidepressant therapy Oral Quantity | Response Lacking | Study Subject Participation Status | Patients transferred

Datentyp

boolean

Alias
UMLS CUI [1]
C4054475
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
UMLS CUI [4]
C2348568
UMLS CUI [5]
C0030704
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
Beschreibung

Induction phase Specified Completed | Clinical Trial Eligibility Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4049995
UMLS CUI [1,2]
C0205369
UMLS CUI [1,3]
C0205197
UMLS CUI [2,1]
C1516637
UMLS CUI [2,2]
C1550543
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
a). for direct-entry participants
Beschreibung

Study Subject Participation Status | Enrollment Direct

Datentyp

boolean

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

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0086132
UMLS CUI [1,2]
C1704632
UMLS CUI [1,3]
C0332268
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]
C1709323
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
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
Beschreibung

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

Datentyp

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]
C1510586
UMLS CUI [8]
C0006012
UMLS CUI [9]
C0003431
UMLS CUI [10]
C0019681
UMLS CUI [11]
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 phase, per the investigator's clinical judgment or based on the columbia suicide severity rating scale (c-ssrs)
Beschreibung

Homicidal thoughts C-SSRS | Homicidal intent C-SSRS

Datentyp

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
Beschreibung

Substance Use Disorder Moderate | Substance Use Disorder Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0038586
UMLS CUI [2,2]
C0205082
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
Beschreibung

Age | Mini-mental state examination | Neurodegenerative Disorders | Alzheimer's Disease | Dementia, Vascular | Parkinson Disease | Mild cognitive disorder | Study Subject Participation Status | Patients transferred

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0451306
UMLS CUI [3]
C0524851
UMLS CUI [4]
C0002395
UMLS CUI [5]
C0011269
UMLS CUI [6]
C0030567
UMLS CUI [7]
C1270972
UMLS CUI [8]
C2348568
UMLS CUI [9]
C0030704
participant has taken any prohibited therapies that would not permit dosing on day 1
Beschreibung

Therapeutic procedure Illicit

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0332266
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Ähnliche Modelle

Eligibility Treatment-resistant Depression NCT02497287

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
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])
Item Group
C0680251 (UMLS CUI)
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])
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