ID

43874

Description

Lilly's Emotional and Physical Symptoms of Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00479453

Link

https://clinicaltrials.gov/show/NCT00479453

Keywords

Versions (2)
  1. 10/19/16 10/19/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00479453

English

Eligibility Major Depressive Disorder NCT00479453

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
meet criteria for major depressive disorder according to the dsm-iv diagnostic criteria
Description

Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1]
C1269683
outpatients at lease 18 years of age
Description

Outpatients | Age

Data type

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
sign the informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
all females must test negative for a urine pregnancy test at visit 1. females of child bearing potential must agree to utilize medically acceptable and reliable means of birth control
Description

Gender Urine pregnancy test negative | Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0430057
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
have a level of understanding sufficient to communicate with the investigator and are able to complete all patient self-rated scales in the study
Description

Able to communicate Investigator | Depression self rating scale Completion Ability

Data type

boolean

Alias
UMLS CUI [1,1]
C2364293
UMLS CUI [1,2]
C0035173
UMLS CUI [2,1]
C0451108
UMLS CUI [2,2]
C0205197
UMLS CUI [2,3]
C0085732
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
are investigator site personnel directly affiliated with the study or immediate family
Description

Research Personnel Affiliated Clinical Trial Family | Research Personnel Affiliated Immediate family

Data type

boolean

Alias
UMLS CUI [1,1]
C0035173
UMLS CUI [1,2]
C1510826
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0015576
UMLS CUI [2,1]
C0035173
UMLS CUI [2,2]
C1510826
UMLS CUI [2,3]
C2371717
are employed by eli lilly and company
Description

Employee Eli Lilly & Co Ltd

Data type

boolean

Alias
UMLS CUI [1,1]
C0599987
UMLS CUI [1,2]
C0470942
have received treatment within the last 30 days or are currently enrolled in a study with a drug that has not received regulatory approval for any indication at time of study entry
Description

Study Subject Participation Status | Therapeutic procedure Drug Approval Lacking

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0162696
UMLS CUI [2,3]
C0332268
current substance dependence, excluding nicotine and caffeine
Description

Substance Dependence | Nicotine Dependence | Caffeine dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2]
C0028043
UMLS CUI [3]
C1386553
treatment with a monoamine oxidase inhibitor within 14 days prior to visit 1 or potential need to use an maoi within 5 days after discontinuation of study drug
Description

Monoamine Oxidase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0026457
acute liver injury or severe (child-pugh class c) cirrhosis
Description

Injury of liver | Liver Cirrhosis Severe | Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1]
C0160390
UMLS CUI [2,1]
C0023890
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C4050412
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Similar models

Eligibility Major Depressive Disorder NCT00479453

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder
Item
meet criteria for major depressive disorder according to the dsm-iv diagnostic criteria
boolean
C1269683 (UMLS CUI [1])
Outpatients | Age
Item
outpatients at lease 18 years of age
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Informed Consent
Item
sign the informed consent
boolean
C0021430 (UMLS CUI [1])
Gender Urine pregnancy test negative | Childbearing Potential Contraceptive methods
Item
all females must test negative for a urine pregnancy test at visit 1. females of child bearing potential must agree to utilize medically acceptable and reliable means of birth control
boolean
C0079399 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Able to communicate Investigator | Depression self rating scale Completion Ability
Item
have a level of understanding sufficient to communicate with the investigator and are able to complete all patient self-rated scales in the study
boolean
C2364293 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C0451108 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Research Personnel Affiliated Clinical Trial Family | Research Personnel Affiliated Immediate family
Item
are investigator site personnel directly affiliated with the study or immediate family
boolean
C0035173 (UMLS CUI [1,1])
C1510826 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0015576 (UMLS CUI [1,4])
C0035173 (UMLS CUI [2,1])
C1510826 (UMLS CUI [2,2])
C2371717 (UMLS CUI [2,3])
Employee Eli Lilly & Co Ltd
Item
are employed by eli lilly and company
boolean
C0599987 (UMLS CUI [1,1])
C0470942 (UMLS CUI [1,2])
Study Subject Participation Status | Therapeutic procedure Drug Approval Lacking
Item
have received treatment within the last 30 days or are currently enrolled in a study with a drug that has not received regulatory approval for any indication at time of study entry
boolean
C2348568 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0162696 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
Substance Dependence | Nicotine Dependence | Caffeine dependence
Item
current substance dependence, excluding nicotine and caffeine
boolean
C0038580 (UMLS CUI [1])
C0028043 (UMLS CUI [2])
C1386553 (UMLS CUI [3])
Monoamine Oxidase Inhibitors
Item
treatment with a monoamine oxidase inhibitor within 14 days prior to visit 1 or potential need to use an maoi within 5 days after discontinuation of study drug
boolean
C0026457 (UMLS CUI [1])
Injury of liver | Liver Cirrhosis Severe | Child-Pugh Classification
Item
acute liver injury or severe (child-pugh class c) cirrhosis
boolean
C0160390 (UMLS CUI [1])
C0023890 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C4050412 (UMLS CUI [3])
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