ID

17125

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT00191685

Trefwoorden

Versies (1)
  1. 25-08-16 25-08-16 -
Geüploaded op

25 augustus 2016

DOI

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Creative Commons BY 4.0
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Eligibility Depressive Disorder, Major NCT00191685

Engels

Eligibility Depressive Disorder, Major NCT00191685

1 Formulieren  
Inclusion Criteria
Beschrijving

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.
Beschrijving

Major depressive disorder with melancholic features

Datatype

boolean

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

Single major depressive episode First | Age

Datatype

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.
Beschrijving

Hamilton rating scale for depression

Datatype

boolean

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

Gender Urine pregnancy test negative

Datatype

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).
Beschrijving

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

Datatype

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
Beschrijving

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.
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

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.
Beschrijving

At risk for suicide Serious

Datatype

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/
Beschrijving

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

Datatype

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.
Beschrijving

Surgical and medical procedures | Hospitalization

Datatype

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.
Beschrijving

Monoamine Oxidase Inhibitors | Investigational New Drug Discontinuation

Datatype

boolean

Alias
UMLS CUI [1]
C0026457
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C1444662
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Similar models

Eligibility Depressive Disorder, Major NCT00191685

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
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