0 Evaluaciones
ID

37443

Descripción

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

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 NCT02418585

    Inglés

    Eligibility Treatment-resistant Depression NCT02418585

    1 formularios  
    Inclusion Criteria
    Descripción

    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
    Descripción

    Informed Consent | Age

    Tipo de datos

    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)
    Descripción

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

    Tipo de datos

    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 -
    Descripción

    IDS-C | Antidepressant therapy Oral Quantity | Response Lacking

    Tipo de datos

    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
    Descripción

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

    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
    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
    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
    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 NCT02418585

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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])
    Volver a la parte superior de la página 

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