ID

12868

Description

A Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression; ODM derived from: https://clinicaltrials.gov/show/NCT02417064

Link

https://clinicaltrials.gov/show/NCT02417064

Keywords

Versions (1)
  1. 1/4/16 1/4/16 -
Uploaded on

January 4, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Treatment-resistant Depression NCT02417064

English

Eligibility Treatment-resistant Depression NCT02417064

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

dsm-5; screening

Data type

boolean

Alias
UMLS CUI [1]
C3710578
UMLS CUI [2]
C0220908
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

Depression score; screening

Data type

boolean

Alias
UMLS CUI [1]
C3483981
UMLS CUI [2]
C0220908
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. participant must be taking an oral antidepressant treatment with nonresponse at the start of the screening/prospective observational phase.
Description

Antidepressant therapy; screening

Data type

boolean

Alias
UMLS CUI [1]
C1096649
UMLS CUI [2]
C0220908
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

Data type

boolean

Alias
UMLS CUI [1]
C0024517
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 (i.e, 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

Antidepressant therapy; ketamine; major depressive episode; electroconvulsive therapy

Data type

boolean

Alias
UMLS CUI [1]
C1096649
UMLS CUI [2]
C1096649
UMLS CUI [3]
C0024517
UMLS CUI [4]
C0013806
participant currently has an implant for vagal nerve stimulation (vns) or has received deep brain stimulation (dbs) in the current episode of depression
Description

vagal nerve stimulation; deep brain stimulation

Data type

boolean

Alias
UMLS CUI [1]
C2350432
UMLS CUI [2]
C0394162
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

dsm-5; psychotic disorder

Data type

boolean

Alias
UMLS CUI [1]
C3710578
UMLS CUI [2]
C0033975
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 ideation; columbia suicide severity rating scale

Data type

boolean

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

Substance Use Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0038586
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Similar models

Eligibility Treatment-resistant Depression NCT02417064

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])
dsm-5; screening
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
C3710578 (UMLS CUI [1])
C0220908 (UMLS CUI [2])
Depression score; screening
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
C3483981 (UMLS CUI [1])
C0220908 (UMLS CUI [2])
Antidepressant therapy; screening
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. participant must be taking an oral antidepressant treatment with nonresponse at the start of the screening/prospective observational phase.
boolean
C1096649 (UMLS CUI [1])
C0220908 (UMLS CUI [2])
major depressive episode
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])
Item Group
C0680251 (UMLS CUI)
Antidepressant therapy; ketamine; major depressive episode; electroconvulsive therapy
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 (i.e, 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
C1096649 (UMLS CUI [1])
C1096649 (UMLS CUI [2])
C0024517 (UMLS CUI [3])
C0013806 (UMLS CUI [4])
vagal nerve stimulation; deep brain stimulation
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])
dsm-5; psychotic 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
C3710578 (UMLS CUI [1])
C0033975 (UMLS CUI [2])
homicidal ideation; columbia suicide severity rating scale
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])
C3888485 (UMLS CUI [2])
Substance Use Disorder
Item
participants with history of moderate or severe substance or alcohol use disorder according to dsm-5 criteria
boolean
C0038586 (UMLS CUI [1])
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