ID

43876

Description

Lilly's Emotional and Physical Symptoms of Depression Study (LEAPS); ODM derived from: https://clinicaltrials.gov/show/NCT00479726

Link

https://clinicaltrials.gov/show/NCT00479726

Keywords

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

September 20, 2021

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Major Depressive Disorder NCT00479726

Eligibility Major Depressive Disorder NCT00479726

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 least 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

Similar models

Eligibility Major Depressive Disorder NCT00479726

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 least 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])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

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