ID

35711

Beschrijving

An Efficacy, Safety and Tolerability Study of JNJ-42165279 in Participants With Major Depressive Disorder With Anxious Distress; ODM derived from: https://clinicaltrials.gov/show/NCT02498392

Link

https://clinicaltrials.gov/show/NCT02498392

Trefwoorden

Versies (1)
  1. 17-03-19 17-03-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

17 maart 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Depressive Disorder NCT02498392

Engels

Eligibility Depressive Disorder NCT02498392

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
participant must meet the diagnostic and statistical manual of mental disorders-iv (dsm-iv) or 5 diagnostic criteria for major depressive disorder (mdd) with anxious distress; participants with a diagnosis of comorbid generalized anxiety disorder, social anxiety disorder, or panic disorder may be included, if the investigator considers mdd with anxious distress to be the primary diagnosis
Beschrijving

Major Depressive Disorder With Distress Anxious | Generalized Anxiety Disorder Comorbid | Social anxiety disorder | Panic Disorder

Datatype

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0332287
UMLS CUI [1,3]
C0231303
UMLS CUI [1,4]
C0003467
UMLS CUI [2,1]
C0270549
UMLS CUI [2,2]
C1275743
UMLS CUI [3]
C4237417
UMLS CUI [4]
C0030319
a 17-item hamilton depression rating scale (hdrs17) total score greater than or equal to (>=)18
Beschrijving

Hamilton Depression Rating Scale 17 Item Clinical Classification

Datatype

boolean

Alias
UMLS CUI [1]
C3639712
a hdrs17 anxiety/somatization factor score >=7
Beschrijving

Hamilton Depression Rating Scale 17 Item Clinical Classification | Anxiety Somatization Factor Score

Datatype

boolean

Alias
UMLS CUI [1]
C3639712
UMLS CUI [2,1]
C0003467
UMLS CUI [2,2]
C0149779
UMLS CUI [2,3]
C1521761
UMLS CUI [2,4]
C0449820
participant must be willing and able to adhere to the prohibitions and restrictions
Beschrijving

Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
participant body mass index (bmi) must be between 18 and 35 kilogram per square meter (kg/m^2) inclusive
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
has other psychiatric condition, including, but not limited to, mdd with psychotic features, bipolar disorder, obsessive-compulsive disorder, post-traumatic stress disorder, borderline personality disorder, eating disorder, or schizophrenia
Beschrijving

DEPRESSIVE DISORDER MAJOR WITH PSYCHOTIC FEATURE | Bipolar Disorder | Obsessive-Compulsive Disorder | Post-Traumatic Stress Disorder | Borderline Personality Disorder | Eating Disorders | Schizophrenia

Datatype

boolean

Alias
UMLS CUI [1]
C0743080
UMLS CUI [2]
C0005586
UMLS CUI [3]
C0028768
UMLS CUI [4]
C0038436
UMLS CUI [5]
C0006012
UMLS CUI [6]
C0013473
UMLS CUI [7]
C0036341
has a length of current major depressive episode (mde) greater than (>) 6 months
Beschrijving

Major depressive episode Duration

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024517
UMLS CUI [1,2]
C0449238
has more than 1 failed antidepressant treatment of adequate dose and duration in the current mde, not including the inadequate response to the current selective serotonin reuptake inhibitor (ssri) or serotonergic/noradrenergic reuptake inhibitor (snri) antidepressant
Beschrijving

Antidepressant therapy Quantity failed | Antidepressant therapy Dose Duration | Major depressive episode | Response Inadequate Selective Serotonin Reuptake Inhibitors | Response Inadequate Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs)

Datatype

boolean

Alias
UMLS CUI [1,1]
C1096649
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0231175
UMLS CUI [2,1]
C1096649
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0449238
UMLS CUI [3]
C0024517
UMLS CUI [4,1]
C1704632
UMLS CUI [4,2]
C0205412
UMLS CUI [4,3]
C0360105
UMLS CUI [5,1]
C1704632
UMLS CUI [5,2]
C0205412
UMLS CUI [5,3]
C1579361
has initiated psychotherapy specific for mdd (such as cognitive behavioral, behavioral, or interpersonal therapy) for the current episode of depression within 6 weeks prior to screening
Beschrijving

Psychotherapy Specific Major Depressive Disorder | Cognitive Therapy Episode of Depressive disorder | Behavior Therapy Episode of Depressive disorder | Interpersonal psychotherapy Episode of Depressive disorder

Datatype

boolean

Alias
UMLS CUI [1,1]
C0033968
UMLS CUI [1,2]
C0205369
UMLS CUI [1,3]
C1269683
UMLS CUI [2,1]
C0009244
UMLS CUI [2,2]
C0332189
UMLS CUI [2,3]
C0011581
UMLS CUI [3,1]
C0004933
UMLS CUI [3,2]
C0332189
UMLS CUI [3,3]
C0011581
UMLS CUI [4,1]
C0871787
UMLS CUI [4,2]
C0332189
UMLS CUI [4,3]
C0011581
has a current or recent history of clinically significant suicidal ideation within the past 6 months, or a history of suicidal behavior within the past year
Beschrijving

Feeling suicidal | Suicidal behavior

Datatype

boolean

Alias
UMLS CUI [1]
C0424000
UMLS CUI [2]
C1760428
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Similar models

Eligibility Depressive Disorder NCT02498392

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder With Distress Anxious | Generalized Anxiety Disorder Comorbid | Social anxiety disorder | Panic Disorder
Item
participant must meet the diagnostic and statistical manual of mental disorders-iv (dsm-iv) or 5 diagnostic criteria for major depressive disorder (mdd) with anxious distress; participants with a diagnosis of comorbid generalized anxiety disorder, social anxiety disorder, or panic disorder may be included, if the investigator considers mdd with anxious distress to be the primary diagnosis
boolean
C1269683 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C0231303 (UMLS CUI [1,3])
C0003467 (UMLS CUI [1,4])
C0270549 (UMLS CUI [2,1])
C1275743 (UMLS CUI [2,2])
C4237417 (UMLS CUI [3])
C0030319 (UMLS CUI [4])
Hamilton Depression Rating Scale 17 Item Clinical Classification
Item
a 17-item hamilton depression rating scale (hdrs17) total score greater than or equal to (>=)18
boolean
C3639712 (UMLS CUI [1])
Hamilton Depression Rating Scale 17 Item Clinical Classification | Anxiety Somatization Factor Score
Item
a hdrs17 anxiety/somatization factor score >=7
boolean
C3639712 (UMLS CUI [1])
C0003467 (UMLS CUI [2,1])
C0149779 (UMLS CUI [2,2])
C1521761 (UMLS CUI [2,3])
C0449820 (UMLS CUI [2,4])
Protocol Compliance
Item
participant must be willing and able to adhere to the prohibitions and restrictions
boolean
C0525058 (UMLS CUI [1])
Body mass index
Item
participant body mass index (bmi) must be between 18 and 35 kilogram per square meter (kg/m^2) inclusive
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
DEPRESSIVE DISORDER MAJOR WITH PSYCHOTIC FEATURE | Bipolar Disorder | Obsessive-Compulsive Disorder | Post-Traumatic Stress Disorder | Borderline Personality Disorder | Eating Disorders | Schizophrenia
Item
has other psychiatric condition, including, but not limited to, mdd with psychotic features, bipolar disorder, obsessive-compulsive disorder, post-traumatic stress disorder, borderline personality disorder, eating disorder, or schizophrenia
boolean
C0743080 (UMLS CUI [1])
C0005586 (UMLS CUI [2])
C0028768 (UMLS CUI [3])
C0038436 (UMLS CUI [4])
C0006012 (UMLS CUI [5])
C0013473 (UMLS CUI [6])
C0036341 (UMLS CUI [7])
Major depressive episode Duration
Item
has a length of current major depressive episode (mde) greater than (>) 6 months
boolean
C0024517 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Antidepressant therapy Quantity failed | Antidepressant therapy Dose Duration | Major depressive episode | Response Inadequate Selective Serotonin Reuptake Inhibitors | Response Inadequate Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs)
Item
has more than 1 failed antidepressant treatment of adequate dose and duration in the current mde, not including the inadequate response to the current selective serotonin reuptake inhibitor (ssri) or serotonergic/noradrenergic reuptake inhibitor (snri) antidepressant
boolean
C1096649 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C1096649 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
C0024517 (UMLS CUI [3])
C1704632 (UMLS CUI [4,1])
C0205412 (UMLS CUI [4,2])
C0360105 (UMLS CUI [4,3])
C1704632 (UMLS CUI [5,1])
C0205412 (UMLS CUI [5,2])
C1579361 (UMLS CUI [5,3])
Psychotherapy Specific Major Depressive Disorder | Cognitive Therapy Episode of Depressive disorder | Behavior Therapy Episode of Depressive disorder | Interpersonal psychotherapy Episode of Depressive disorder
Item
has initiated psychotherapy specific for mdd (such as cognitive behavioral, behavioral, or interpersonal therapy) for the current episode of depression within 6 weeks prior to screening
boolean
C0033968 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C1269683 (UMLS CUI [1,3])
C0009244 (UMLS CUI [2,1])
C0332189 (UMLS CUI [2,2])
C0011581 (UMLS CUI [2,3])
C0004933 (UMLS CUI [3,1])
C0332189 (UMLS CUI [3,2])
C0011581 (UMLS CUI [3,3])
C0871787 (UMLS CUI [4,1])
C0332189 (UMLS CUI [4,2])
C0011581 (UMLS CUI [4,3])
Feeling suicidal | Suicidal behavior
Item
has a current or recent history of clinically significant suicidal ideation within the past 6 months, or a history of suicidal behavior within the past year
boolean
C0424000 (UMLS CUI [1])
C1760428 (UMLS CUI [2])
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