ID

17117

Description

Study Of GW679769 In Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT00102492

Link

https://clinicaltrials.gov/show/NCT00102492

Keywords

  1. 8/25/16 8/25/16 -
Uploaded on

August 25, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Depressive Disorder, Major NCT00102492

Eligibility Depressive Disorder, Major NCT00102492

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects must have the ability to comprehend the key components of the consent form.
Description

Informed Consent Comprehension

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0162340
subject must have met dsm-iv-tr (diagnostic and statistical manual of mental disorders, fourth edition, text revision) criteria for current mde (major depressive episode) for at least 8 weeks prior to the screening visit.
Description

Single major depressive episode

Data type

boolean

Alias
UMLS CUI [1]
C0024517
if female, subjects must be practicing an acceptable method of birth control.
Description

Gender Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
subjects must have rating scores as outlined.
Description

Global assessment of functioning

Data type

boolean

Alias
UMLS CUI [1]
C0561904
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects whose symptoms of the mde are better accounted for by another diagnosis.
Description

Single major depressive episode Symptoms | Diagnosis Suboptimal

Data type

boolean

Alias
UMLS CUI [1,1]
C0024517
UMLS CUI [1,2]
C1457887
UMLS CUI [2,1]
C0011900
UMLS CUI [2,2]
C2984009
subjects with a history of schizophrenia, schizoaffective disorders or bipolar disorder.
Description

Schizophrenia | Schizoaffective Disorder | Bipolar Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036337
UMLS CUI [3]
C0005586
subjects have a positive urine test for illicit drug use and/or a history of substance abuse or alcohol dependence within the past 12 months.
Description

Illicit drug use Urine test Positive | Substance Use Disorders | Alcohol dependence

Data type

boolean

Alias
UMLS CUI [1,1]
C0281875
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C1514241
UMLS CUI [2]
C0038586
UMLS CUI [3]
C0001973
subjects with an unstable medical disorder.
Description

Disease Unstable

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0443343
if female, pregnant or lactating.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
subjects who have received ect (electroconvulsive therapy) or tms (transcranial magnetic stimulation) within the 6 months preceding screening or who have ever been homicidal.
Description

Electroconvulsive Therapy | Transcranial magnetic stimulation | homicidal

Data type

boolean

Alias
UMLS CUI [1]
C0013806
UMLS CUI [2]
C0436548
UMLS CUI [3]
C0745031

Similar models

Eligibility Depressive Disorder, Major NCT00102492

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent Comprehension
Item
subjects must have the ability to comprehend the key components of the consent form.
boolean
C0021430 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
Single major depressive episode
Item
subject must have met dsm-iv-tr (diagnostic and statistical manual of mental disorders, fourth edition, text revision) criteria for current mde (major depressive episode) for at least 8 weeks prior to the screening visit.
boolean
C0024517 (UMLS CUI [1])
Gender Contraceptive methods
Item
if female, subjects must be practicing an acceptable method of birth control.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Global assessment of functioning
Item
subjects must have rating scores as outlined.
boolean
C0561904 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Single major depressive episode Symptoms | Diagnosis Suboptimal
Item
subjects whose symptoms of the mde are better accounted for by another diagnosis.
boolean
C0024517 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2,1])
C2984009 (UMLS CUI [2,2])
Schizophrenia | Schizoaffective Disorder | Bipolar Disorder
Item
subjects with a history of schizophrenia, schizoaffective disorders or bipolar disorder.
boolean
C0036341 (UMLS CUI [1])
C0036337 (UMLS CUI [2])
C0005586 (UMLS CUI [3])
Illicit drug use Urine test Positive | Substance Use Disorders | Alcohol dependence
Item
subjects have a positive urine test for illicit drug use and/or a history of substance abuse or alcohol dependence within the past 12 months.
boolean
C0281875 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C0038586 (UMLS CUI [2])
C0001973 (UMLS CUI [3])
Disease Unstable
Item
subjects with an unstable medical disorder.
boolean
C0012634 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
if female, pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Electroconvulsive Therapy | Transcranial magnetic stimulation | homicidal
Item
subjects who have received ect (electroconvulsive therapy) or tms (transcranial magnetic stimulation) within the 6 months preceding screening or who have ever been homicidal.
boolean
C0013806 (UMLS CUI [1])
C0436548 (UMLS CUI [2])
C0745031 (UMLS CUI [3])

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