ID

21768

Description

An Open Trial of Duloxetine on Comorbid Major Depression and Chronic Headache; ODM derived from: https://clinicaltrials.gov/show/NCT00531895

Link

https://clinicaltrials.gov/show/NCT00531895

Keywords

Versions (1)
  1. 4/29/17 4/29/17 -
Uploaded on

April 29, 2017

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.

Back to model comments
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 Depression NCT00531895

English

Eligibility Major Depression NCT00531895

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
major depression (according to dsm-iv criteria)
Description

Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1]
C1269683
madrs scores superior to 21
Description

Montgomery-Asberg Depression Rating Scale Questionnaire

Data type

boolean

Alias
UMLS CUI [1]
C4054475
subjects meeting the international headache society criteria for chronic primary headache (ihsc-2 codes 1.5.1, 1.6.1, 2.3.1, 2.3.2 and 2.4.3) (ichs, 2003)
Description

Primary Headache Disorder chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C1565106
UMLS CUI [1,2]
C0205191
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
over 50% reduction on madrs scores during wash-out period
Description

Montgomery-Asberg Depression Rating Scale Questionnaire Reduction Percentage Washout Period

Data type

boolean

Alias
UMLS CUI [1,1]
C4054475
UMLS CUI [1,2]
C0392756
UMLS CUI [1,3]
C0439165
UMLS CUI [1,4]
C1710661
illicit drug or alcohol dependence
Description

Illicit Drugs Dependence | Alcoholic Intoxication, Chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0086190
UMLS CUI [1,2]
C0439857
UMLS CUI [2]
C0001973
history of multiple allergies or hypersensitivity to duloxetine
Description

Multiple allergies | Hypersensitivity duloxetine

Data type

boolean

Alias
UMLS CUI [1]
C0740281
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0245561
history of epilepsy or significant neurological disorder
Description

Epilepsy | nervous system disorder

Data type

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2]
C0027765
significant suicide risk
Description

At risk for suicide

Data type

boolean

Alias
UMLS CUI [1]
C0563664
pregnancy or lactation
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
sexually active female subjects not using an efficient contraceptive method
Description

Gender Sexually active | Contraceptive methods Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0241028
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0332268
significant laboratory abnormalities at baseline
Description

LABORATORY ABNORMALITIES

Data type

boolean

Alias
UMLS CUI [1]
C1853129
significant clinical disease
Description

Disease Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826293
subjects meeting dsm-iv criteria for somatisation disorder. (300.81) or presenting with delusional pain symptoms.
Description

Somatization Disorder | Delusional pain Symptoms

Data type

boolean

Alias
UMLS CUI [1]
C0520482
UMLS CUI [2,1]
C0394998
UMLS CUI [2,2]
C1457887
Back to the top of the page

Similar models

Eligibility Major Depression NCT00531895

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder
Item
major depression (according to dsm-iv criteria)
boolean
C1269683 (UMLS CUI [1])
Montgomery-Asberg Depression Rating Scale Questionnaire
Item
madrs scores superior to 21
boolean
C4054475 (UMLS CUI [1])
Primary Headache Disorder chronic
Item
subjects meeting the international headache society criteria for chronic primary headache (ihsc-2 codes 1.5.1, 1.6.1, 2.3.1, 2.3.2 and 2.4.3) (ichs, 2003)
boolean
C1565106 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Montgomery-Asberg Depression Rating Scale Questionnaire Reduction Percentage Washout Period
Item
over 50% reduction on madrs scores during wash-out period
boolean
C4054475 (UMLS CUI [1,1])
C0392756 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C1710661 (UMLS CUI [1,4])
Illicit Drugs Dependence | Alcoholic Intoxication, Chronic
Item
illicit drug or alcohol dependence
boolean
C0086190 (UMLS CUI [1,1])
C0439857 (UMLS CUI [1,2])
C0001973 (UMLS CUI [2])
Multiple allergies | Hypersensitivity duloxetine
Item
history of multiple allergies or hypersensitivity to duloxetine
boolean
C0740281 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0245561 (UMLS CUI [2,2])
Epilepsy | nervous system disorder
Item
history of epilepsy or significant neurological disorder
boolean
C0014544 (UMLS CUI [1])
C0027765 (UMLS CUI [2])
At risk for suicide
Item
significant suicide risk
boolean
C0563664 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Gender Sexually active | Contraceptive methods Lacking
Item
sexually active female subjects not using an efficient contraceptive method
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
LABORATORY ABNORMALITIES
Item
significant laboratory abnormalities at baseline
boolean
C1853129 (UMLS CUI [1])
Disease Clinical Significance
Item
significant clinical disease
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Somatization Disorder | Delusional pain Symptoms
Item
subjects meeting dsm-iv criteria for somatisation disorder. (300.81) or presenting with delusional pain symptoms.
boolean
C0520482 (UMLS CUI [1])
C0394998 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
Back to the top of the page 

Contact

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

Fields marked with * are required.

Help

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