ID

33621

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01128452

Nyckelord

  1. 16/12/18 16/12/18 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

16 dicembre 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Depression NCT01128452

Eligibility Depression NCT01128452

  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT01128452
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
major depressive disorder
Beskrivning

Major Depressive Disorder

Datatyp

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
Beskrivning

Major depression, single episode | Therapeutic procedure Quantity failed

Datatyp

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
Beskrivning

Hamilton Depression Rating Scale 17 Item Clinical Classification

Datatyp

boolean

Alias
UMLS CUI [1]
C3639712
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or breast-feeding women
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

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

Impaired cognition Age Related | Mild dementia

Datatyp

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
Beskrivning

At risk for suicide

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

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

Similar models

Eligibility Depression NCT01128452

  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT01128452
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial