ID

17125

Description

Duloxetine in the Treatment of Melancholic Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00191685

Link

https://clinicaltrials.gov/show/NCT00191685

Keywords

Versions (1)
  1. 8/25/16 8/25/16 -
Uploaded on

August 25, 2016

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 Depressive Disorder, Major NCT00191685

English

Eligibility Depressive Disorder, Major NCT00191685

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
have a diagnosis of major depression with melancholic features, as defined by diagnostic and statistical manual of mental disorders fourth edition [dsm-iv] criteria.
Description

Major depressive disorder with melancholic features

Data type

boolean

Alias
UMLS CUI [1]
C1096724
experienced their first episode of major depression prior to age 50.
Description

Single major depressive episode First | Age

Data type

boolean

Alias
UMLS CUI [1,1]
C0024517
UMLS CUI [1,2]
C0205435
UMLS CUI [2]
C0001779
have a hamd17 total score of less than or equal to 20 at visits 1 and 2.
Description

Hamilton rating scale for depression

Data type

boolean

Alias
UMLS CUI [1]
C0451203
test negative for a urine pregnancy test at visit 1 (females).
Description

Gender Urine pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0430057
agree to use medically acceptable and reliable means of birth control during the study, as determined by the investigator (females of child-bearing potential, not surgically sterilized and between menarche, and one year post-menopausal).
Description

Childbearing Potential Contraceptive methods | Female Sterilization | Menarche between | Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C0025274
UMLS CUI [3,2]
C0205103
UMLS CUI [4]
C0232970
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have any current and primary axis i mood disorder other than mdd, including, but not limited to, dysthymia, seasonal affective disorder or psychotic depression.
Description

Axis I diagnosis Mood Disorder Primary | Major Depressive Disorder | Dysthymic Disorder | Seasonal Affective Disorder | Depression, psychotic

Data type

boolean

Alias
UMLS CUI [1,1]
C0270287
UMLS CUI [1,2]
C0525045
UMLS CUI [1,3]
C0205225
UMLS CUI [2]
C1269683
UMLS CUI [3]
C0013415
UMLS CUI [4]
C0085159
UMLS CUI [5]
C0743072
have a current episode of major depression that has failed to respond to two or more courses of antidepressant therapy or, in the judgment of the investigator, meets criteria for treatment-resistant depression
Description

Single major depressive episode | Antidepressive Agents Course Quantity Unresponsive to Treatment | Depressive Disorder, Treatment-Resistant

Data type

boolean

Alias
UMLS CUI [1]
C0024517
UMLS CUI [2,1]
C0003289
UMLS CUI [2,2]
C0750729
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0205269
UMLS CUI [3]
C2063866
are at serious suicidal risk as determined by the investigator.
Description

At risk for suicide Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0563664
UMLS CUI [1,2]
C0205404
have a serious medical illness or clinically significant laboratory abnormalities that, in the judgment of the investigator, are likely to require medication/
Description

Illness Serious Requirement Pharmaceutical Preparations | LABORATORY ABNORMALITIES Clinical Significance Requirement Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C0013227
UMLS CUI [2,1]
C1853129
UMLS CUI [2,2]
C2826293
UMLS CUI [2,3]
C1514873
UMLS CUI [2,4]
C0013227
intervention/ hospitalization during the course of the study.
Description

Surgical and medical procedures | Hospitalization

Data type

boolean

Alias
UMLS CUI [1]
C1948041
UMLS CUI [2]
C0019993
had treatment with a monoamine oxidase inhibitor (maoi) within 14 days prior to visit 2 or potential need to use a maoi during the study or within 14 days of discontinuation of study drug.
Description

Monoamine Oxidase Inhibitors | Investigational New Drug Discontinuation

Data type

boolean

Alias
UMLS CUI [1]
C0026457
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C1444662
Back to the top of the page

Similar models

Eligibility Depressive Disorder, Major NCT00191685

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Major depressive disorder with melancholic features
Item
have a diagnosis of major depression with melancholic features, as defined by diagnostic and statistical manual of mental disorders fourth edition [dsm-iv] criteria.
boolean
C1096724 (UMLS CUI [1])
Single major depressive episode First | Age
Item
experienced their first episode of major depression prior to age 50.
boolean
C0024517 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
Hamilton rating scale for depression
Item
have a hamd17 total score of less than or equal to 20 at visits 1 and 2.
boolean
C0451203 (UMLS CUI [1])
Gender Urine pregnancy test negative
Item
test negative for a urine pregnancy test at visit 1 (females).
boolean
C0079399 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods | Female Sterilization | Menarche between | Postmenopausal state
Item
agree to use medically acceptable and reliable means of birth control during the study, as determined by the investigator (females of child-bearing potential, not surgically sterilized and between menarche, and one year post-menopausal).
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0015787 (UMLS CUI [2])
C0025274 (UMLS CUI [3,1])
C0205103 (UMLS CUI [3,2])
C0232970 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Axis I diagnosis Mood Disorder Primary | Major Depressive Disorder | Dysthymic Disorder | Seasonal Affective Disorder | Depression, psychotic
Item
have any current and primary axis i mood disorder other than mdd, including, but not limited to, dysthymia, seasonal affective disorder or psychotic depression.
boolean
C0270287 (UMLS CUI [1,1])
C0525045 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C1269683 (UMLS CUI [2])
C0013415 (UMLS CUI [3])
C0085159 (UMLS CUI [4])
C0743072 (UMLS CUI [5])
Single major depressive episode | Antidepressive Agents Course Quantity Unresponsive to Treatment | Depressive Disorder, Treatment-Resistant
Item
have a current episode of major depression that has failed to respond to two or more courses of antidepressant therapy or, in the judgment of the investigator, meets criteria for treatment-resistant depression
boolean
C0024517 (UMLS CUI [1])
C0003289 (UMLS CUI [2,1])
C0750729 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0205269 (UMLS CUI [2,4])
C2063866 (UMLS CUI [3])
At risk for suicide Serious
Item
are at serious suicidal risk as determined by the investigator.
boolean
C0563664 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Illness Serious Requirement Pharmaceutical Preparations | LABORATORY ABNORMALITIES Clinical Significance Requirement Pharmaceutical Preparations
Item
have a serious medical illness or clinically significant laboratory abnormalities that, in the judgment of the investigator, are likely to require medication/
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
C1853129 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C0013227 (UMLS CUI [2,4])
Surgical and medical procedures | Hospitalization
Item
intervention/ hospitalization during the course of the study.
boolean
C1948041 (UMLS CUI [1])
C0019993 (UMLS CUI [2])
Monoamine Oxidase Inhibitors | Investigational New Drug Discontinuation
Item
had treatment with a monoamine oxidase inhibitor (maoi) within 14 days prior to visit 2 or potential need to use a maoi during the study or within 14 days of discontinuation of study drug.
boolean
C0026457 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C1444662 (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