ID

33621

Description

Safety and Efficacy of EVT 101 in Treatment-Resistant Depression; ODM derived from: https://clinicaltrials.gov/show/NCT01128452

Link

https://clinicaltrials.gov/show/NCT01128452

Keywords

Versions (1)
  1. 12/16/18 12/16/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 16, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Depression NCT01128452

English

Eligibility Depression NCT01128452

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT01128452
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
major depressive disorder
Description

Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1]
C1269683
current episode of major depression that has not benefited from at least 1 but no more than 3 adequate treatment regimens
Description

Major depression, single episode | Therapeutic procedure Quantity failed

Data type

boolean

Alias
UMLS CUI [1]
C0024517
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0231175
has as score of >/= 18 on the ham-d-17
Description

Hamilton Depression Rating Scale 17 Item Clinical Classification

Data type

boolean

Alias
UMLS CUI [1]
C3639712
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or breast-feeding women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
evidence of age-related cognitive decline or mild dementia
Description

Impaired cognition Age Related | Mild dementia

Data type

boolean

Alias
UMLS CUI [1,1]
C0338656
UMLS CUI [1,2]
C0001779
UMLS CUI [1,3]
C0439849
UMLS CUI [2]
C3494623
at imminent risk of committing suicide
Description

At risk for suicide

Data type

boolean

Alias
UMLS CUI [1]
C0563664
has with the exception of major depression, a serious medical or neurological illness, including seizure disorder, stroke, dementia, or parkinson disease
Description

Exception Major Depressive Disorder | Illness Serious | Nervous system disorder Serious | Epilepsy | Cerebrovascular accident | Dementia | Parkinson Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C1269683
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205404
UMLS CUI [3,1]
C0027765
UMLS CUI [3,2]
C0205404
UMLS CUI [4]
C0014544
UMLS CUI [5]
C0038454
UMLS CUI [6]
C0497327
UMLS CUI [7]
C0030567
has an established diagnosis of bipolar disorder, hypomania, schizoaffective disorder, major depression with psychotic features or schizophrenia
Description

Bipolar Disorder | Hypomania | Schizoaffective Disorder | Major depression with psychotic features | Schizophrenia

Data type

boolean

Alias
UMLS CUI [1]
C0005586
UMLS CUI [2]
C0241934
UMLS CUI [3]
C0036337
UMLS CUI [4]
C4518519
UMLS CUI [5]
C0036341
has had a substance or alcohol abuse or dependence disorder (except nicotine and caffeine) in the 1 year before screening
Description

Substance Use Disorders | Substance Dependence | Exception Nicotine Dependence | Exception Caffeine dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0028043
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1386553
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Similar models

Eligibility Depression NCT01128452

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT01128452
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder
Item
major depressive disorder
boolean
C1269683 (UMLS CUI [1])
Major depression, single episode | Therapeutic procedure Quantity failed
Item
current episode of major depression that has not benefited from at least 1 but no more than 3 adequate treatment regimens
boolean
C0024517 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
Hamilton Depression Rating Scale 17 Item Clinical Classification
Item
has as score of >/= 18 on the ham-d-17
boolean
C3639712 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Impaired cognition Age Related | Mild dementia
Item
evidence of age-related cognitive decline or mild dementia
boolean
C0338656 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C3494623 (UMLS CUI [2])
At risk for suicide
Item
at imminent risk of committing suicide
boolean
C0563664 (UMLS CUI [1])
Exception Major Depressive Disorder | Illness Serious | Nervous system disorder Serious | Epilepsy | Cerebrovascular accident | Dementia | Parkinson Disease
Item
has with the exception of major depression, a serious medical or neurological illness, including seizure disorder, stroke, dementia, or parkinson disease
boolean
C1705847 (UMLS CUI [1,1])
C1269683 (UMLS CUI [1,2])
C0221423 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0027765 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0014544 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
C0497327 (UMLS CUI [6])
C0030567 (UMLS CUI [7])
Bipolar Disorder | Hypomania | Schizoaffective Disorder | Major depression with psychotic features | Schizophrenia
Item
has an established diagnosis of bipolar disorder, hypomania, schizoaffective disorder, major depression with psychotic features or schizophrenia
boolean
C0005586 (UMLS CUI [1])
C0241934 (UMLS CUI [2])
C0036337 (UMLS CUI [3])
C4518519 (UMLS CUI [4])
C0036341 (UMLS CUI [5])
Substance Use Disorders | Substance Dependence | Exception Nicotine Dependence | Exception Caffeine dependence
Item
has had a substance or alcohol abuse or dependence disorder (except nicotine and caffeine) in the 1 year before screening
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0028043 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C1386553 (UMLS CUI [4,2])
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