ID

35714

Description

An Efficacy and Safety Study of Sirukumab in Participants With Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT02473289

Link

https://clinicaltrials.gov/show/NCT02473289

Keywords

Versions (2)
  1. 3/17/19 3/17/19 -
  2. 3/17/19 3/17/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 17, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Depressive Disorder, Major NCT02473289

English

Eligibility Depressive Disorder, Major NCT02473289

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants must have a primary dsm-5 diagnosis of mdd
Description

Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1]
C1269683
must have a hdrs total score greater than or equal to (>=) 18 at screening and predose at day 1, as recorded by the remote independent rater and must not demonstrate an improvement of >= 20 percent (%) on their hdrs total score from the screening to baseline visit
Description

Hamilton rating scale for depression

Data type

boolean

Alias
UMLS CUI [1]
C0451203
must have a hscrp >=0.300 milligram per deciliters (mg/dl) (si 3.00 mg/l) at screening
Description

hsCRP

Data type

boolean

Alias
UMLS CUI [1]
C0973334
must be medically stable on the basis of physical examination, medical history, vital signs, clinical laboratory tests and 12-lead ecg performed at screening. if there are abnormalities, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. this determination must be recorded in the subject's source documents and initialed by the investigator
Description

Stable status Medical Physical Examination | Stable status Medical Medical History | Stable status Medical Vital signs | Stable status Medical Laboratory Procedures | Stable status Medical 12 lead ECG

Data type

boolean

Alias
UMLS CUI [1,1]
C0205360
UMLS CUI [1,2]
C0205476
UMLS CUI [1,3]
C0031809
UMLS CUI [2,1]
C0205360
UMLS CUI [2,2]
C0205476
UMLS CUI [2,3]
C0262926
UMLS CUI [3,1]
C0205360
UMLS CUI [3,2]
C0205476
UMLS CUI [3,3]
C0150404
UMLS CUI [4,1]
C0205360
UMLS CUI [4,2]
C0205476
UMLS CUI [4,3]
C0022885
UMLS CUI [5,1]
C0205360
UMLS CUI [5,2]
C0205476
UMLS CUI [5,3]
C0430456
participants with hypothyroidism who are on stable treatment for 3 months prior to screening are required to have thyroid stimulating hormone (tsh) and free thyroxine (ft4) obtained. if the tsh value is out of range, but ft4 is normal, such cases should be discussed directly with the medical monitor before the subject is enrolled. if the ft4 value is out of range, the participant is not eligible
Description

Therapeutic procedure Stable Hypothyroidism | Requirement Thyrotropin | Requirement Free thyroxin | Thyroid stimulating hormone measurement | T4 free measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0020676
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0040160
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0312452
UMLS CUI [4]
C0202230
UMLS CUI [5]
C0202225
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any other current axis one psychiatric condition, including, but not limited to, mdd with current psychotic features, bipolar disorder (including lifetime diagnosis), obsessive-compulsive disorder, borderline personality disorder, eating disorder (eg, bulimia, anorexia nervosa), or schizophrenia (lifetime). the mini will be used to screen for comorbid psychiatric diagnoses. as noted above, subjects with a diagnosis of comorbid gad, post-traumatic stress disorder, social anxiety disorder, panic disorder or nicotine/caffeine dependence may be included, if the investigator considers mdd to be the primary diagnosis
Description

Axis I diagnosis | DEPRESSIVE DISORDER MAJOR WITH PSYCHOTIC FEATURE | Bipolar Disorder | Bipolar Disorder Lifetime | Obsessive-Compulsive Disorder | Borderline Personality Disorder | Eating Disorders | Bulimia | Anorexia Nervosa | Schizophrenia Lifetime | Generalized Anxiety Disorder Comorbid allowed | Post-Traumatic Stress Disorder Comorbid allowed | Social Phobia Comorbid allowed | Panic Disorder Comorbid allowed | Nicotine Dependence Comorbid allowed | Caffeine dependence Comorbid allowed

Data type

boolean

Alias
UMLS CUI [1]
C0270287
UMLS CUI [2]
C0743080
UMLS CUI [3]
C0005586
UMLS CUI [4,1]
C0005586
UMLS CUI [4,2]
C4071830
UMLS CUI [5]
C0028768
UMLS CUI [6]
C0006012
UMLS CUI [7]
C0013473
UMLS CUI [8]
C0006370
UMLS CUI [9]
C0003125
UMLS CUI [10,1]
C0036341
UMLS CUI [10,2]
C4071830
UMLS CUI [11,1]
C0270549
UMLS CUI [11,2]
C1275743
UMLS CUI [11,3]
C0683607
UMLS CUI [12,1]
C0038436
UMLS CUI [12,2]
C1275743
UMLS CUI [12,3]
C0683607
UMLS CUI [13,1]
C0031572
UMLS CUI [13,2]
C1275743
UMLS CUI [13,3]
C0683607
UMLS CUI [14,1]
C0030319
UMLS CUI [14,2]
C1275743
UMLS CUI [14,3]
C0683607
UMLS CUI [15,1]
C0028043
UMLS CUI [15,2]
C1275743
UMLS CUI [15,3]
C0683607
UMLS CUI [16,1]
C1386553
UMLS CUI [16,2]
C1275743
UMLS CUI [16,3]
C0683607
a history of alcohol or substance use disorder (abuse/dependence) within 6 months prior to screening (nicotine and caffeine dependence are not exclusionary)
Description

Substance Use Disorders | Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
a current or recent (within the past year) history of clinically significant suicidal ideation (corresponding to a score of >= 3 for ideation) or any suicidal behavior within the past year, as validated on the c-ssrs at screening or baseline. subjects with a prior suicide attempt of any sort, or history of prior serious suicidal ideation/plan should be carefully screened for current suicidal ideation and only included at the discretion of the investigator
Description

Feeling suicidal Score | Suicidal behavior Columbia suicide severity rating scale

Data type

boolean

Alias
UMLS CUI [1,1]
C0424000
UMLS CUI [1,2]
C0449820
UMLS CUI [2,1]
C1760428
UMLS CUI [2,2]
C3888485
more than 3 failed antidepressant treatments (of adequate dose and duration) in the current episode of depression (verified by the mgh-atrq)
Description

Antidepressant therapy Quantity failed | Antidepressant therapy Dosage Duration | Episode of Depressive disorder | Response to antidepressant Questionnaires

Data type

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 [3,1]
C0332189
UMLS CUI [3,2]
C0011581
UMLS CUI [4,1]
C3549249
UMLS CUI [4,2]
C0034394
length of current major depressive episode > 24 months
Description

Major depressive episode Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0024517
UMLS CUI [1,2]
C0449238
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Similar models

Eligibility Depressive Disorder, Major NCT02473289

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder
Item
participants must have a primary dsm-5 diagnosis of mdd
boolean
C1269683 (UMLS CUI [1])
Hamilton rating scale for depression
Item
must have a hdrs total score greater than or equal to (>=) 18 at screening and predose at day 1, as recorded by the remote independent rater and must not demonstrate an improvement of >= 20 percent (%) on their hdrs total score from the screening to baseline visit
boolean
C0451203 (UMLS CUI [1])
hsCRP
Item
must have a hscrp >=0.300 milligram per deciliters (mg/dl) (si 3.00 mg/l) at screening
boolean
C0973334 (UMLS CUI [1])
Stable status Medical Physical Examination | Stable status Medical Medical History | Stable status Medical Vital signs | Stable status Medical Laboratory Procedures | Stable status Medical 12 lead ECG
Item
must be medically stable on the basis of physical examination, medical history, vital signs, clinical laboratory tests and 12-lead ecg performed at screening. if there are abnormalities, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. this determination must be recorded in the subject's source documents and initialed by the investigator
boolean
C0205360 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,3])
C0205360 (UMLS CUI [2,1])
C0205476 (UMLS CUI [2,2])
C0262926 (UMLS CUI [2,3])
C0205360 (UMLS CUI [3,1])
C0205476 (UMLS CUI [3,2])
C0150404 (UMLS CUI [3,3])
C0205360 (UMLS CUI [4,1])
C0205476 (UMLS CUI [4,2])
C0022885 (UMLS CUI [4,3])
C0205360 (UMLS CUI [5,1])
C0205476 (UMLS CUI [5,2])
C0430456 (UMLS CUI [5,3])
Therapeutic procedure Stable Hypothyroidism | Requirement Thyrotropin | Requirement Free thyroxin | Thyroid stimulating hormone measurement | T4 free measurement
Item
participants with hypothyroidism who are on stable treatment for 3 months prior to screening are required to have thyroid stimulating hormone (tsh) and free thyroxine (ft4) obtained. if the tsh value is out of range, but ft4 is normal, such cases should be discussed directly with the medical monitor before the subject is enrolled. if the ft4 value is out of range, the participant is not eligible
boolean
C0087111 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0020676 (UMLS CUI [1,3])
C1514873 (UMLS CUI [2,1])
C0040160 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C0312452 (UMLS CUI [3,2])
C0202230 (UMLS CUI [4])
C0202225 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Axis I diagnosis | DEPRESSIVE DISORDER MAJOR WITH PSYCHOTIC FEATURE | Bipolar Disorder | Bipolar Disorder Lifetime | Obsessive-Compulsive Disorder | Borderline Personality Disorder | Eating Disorders | Bulimia | Anorexia Nervosa | Schizophrenia Lifetime | Generalized Anxiety Disorder Comorbid allowed | Post-Traumatic Stress Disorder Comorbid allowed | Social Phobia Comorbid allowed | Panic Disorder Comorbid allowed | Nicotine Dependence Comorbid allowed | Caffeine dependence Comorbid allowed
Item
any other current axis one psychiatric condition, including, but not limited to, mdd with current psychotic features, bipolar disorder (including lifetime diagnosis), obsessive-compulsive disorder, borderline personality disorder, eating disorder (eg, bulimia, anorexia nervosa), or schizophrenia (lifetime). the mini will be used to screen for comorbid psychiatric diagnoses. as noted above, subjects with a diagnosis of comorbid gad, post-traumatic stress disorder, social anxiety disorder, panic disorder or nicotine/caffeine dependence may be included, if the investigator considers mdd to be the primary diagnosis
boolean
C0270287 (UMLS CUI [1])
C0743080 (UMLS CUI [2])
C0005586 (UMLS CUI [3])
C0005586 (UMLS CUI [4,1])
C4071830 (UMLS CUI [4,2])
C0028768 (UMLS CUI [5])
C0006012 (UMLS CUI [6])
C0013473 (UMLS CUI [7])
C0006370 (UMLS CUI [8])
C0003125 (UMLS CUI [9])
C0036341 (UMLS CUI [10,1])
C4071830 (UMLS CUI [10,2])
C0270549 (UMLS CUI [11,1])
C1275743 (UMLS CUI [11,2])
C0683607 (UMLS CUI [11,3])
C0038436 (UMLS CUI [12,1])
C1275743 (UMLS CUI [12,2])
C0683607 (UMLS CUI [12,3])
C0031572 (UMLS CUI [13,1])
C1275743 (UMLS CUI [13,2])
C0683607 (UMLS CUI [13,3])
C0030319 (UMLS CUI [14,1])
C1275743 (UMLS CUI [14,2])
C0683607 (UMLS CUI [14,3])
C0028043 (UMLS CUI [15,1])
C1275743 (UMLS CUI [15,2])
C0683607 (UMLS CUI [15,3])
C1386553 (UMLS CUI [16,1])
C1275743 (UMLS CUI [16,2])
C0683607 (UMLS CUI [16,3])
Substance Use Disorders | Substance Dependence
Item
a history of alcohol or substance use disorder (abuse/dependence) within 6 months prior to screening (nicotine and caffeine dependence are not exclusionary)
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Feeling suicidal Score | Suicidal behavior Columbia suicide severity rating scale
Item
a current or recent (within the past year) history of clinically significant suicidal ideation (corresponding to a score of >= 3 for ideation) or any suicidal behavior within the past year, as validated on the c-ssrs at screening or baseline. subjects with a prior suicide attempt of any sort, or history of prior serious suicidal ideation/plan should be carefully screened for current suicidal ideation and only included at the discretion of the investigator
boolean
C0424000 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
C1760428 (UMLS CUI [2,1])
C3888485 (UMLS CUI [2,2])
Antidepressant therapy Quantity failed | Antidepressant therapy Dosage Duration | Episode of Depressive disorder | Response to antidepressant Questionnaires
Item
more than 3 failed antidepressant treatments (of adequate dose and duration) in the current episode of depression (verified by the mgh-atrq)
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])
C0332189 (UMLS CUI [3,1])
C0011581 (UMLS CUI [3,2])
C3549249 (UMLS CUI [4,1])
C0034394 (UMLS CUI [4,2])
Major depressive episode Duration
Item
length of current major depressive episode > 24 months
boolean
C0024517 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
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