English

Eligibility Major Depressive Disorder NCT00411099

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of major depressive disorder, single or recurrent episode, according to dsm-iv criteria
Description

Single major depressive episode | Recurrent major depressive episode

Data type

boolean

Alias
UMLS CUI [1]
C0024517
UMLS CUI [2]
C0154409
ham-d17 total score > or = 22 at screening and baseline
Description

Hamilton Depression Rating Scale 17 Item Questionnaire

Data type

boolean

Alias
UMLS CUI [1]
C3639712
cgi-severity score > or = 4 at screening and baseline
Description

Clinical Global Impression Questionnaire

Data type

boolean

Alias
UMLS CUI [1]
C3639708
only patients who complete the core protocol are eligible to participate in the open-label extension phase
Description

Protocol Compliance Complete | Participation Open Label Study

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0679823
UMLS CUI [2,2]
C1709323
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of bipolar disorder (i or ii), schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder
Description

Bipolar I disorder | Bipolar II disorder | Schizophrenia | Schizoaffective Disorder | Eating Disorders | Obsessive-Compulsive Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0853193
UMLS CUI [2]
C0236788
UMLS CUI [3]
C0036341
UMLS CUI [4]
C0036337
UMLS CUI [5]
C0013473
UMLS CUI [6]
C0028768
any current axis i disorder other than major depressive disorder which is the focus of treatment
Description

Axis I diagnosis | Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0270287
UMLS CUI [2]
C1269683
substance or alcohol abuse in the last 30 days, dependence in the last 6 months
Description

Substance Use Disorders | Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
concomitant psychotropic medication, including herbal preparations and melatonin
Description

Psychotropic Drugs | Plant Preparations | Melatonin

Data type

boolean

Alias
UMLS CUI [1]
C0033978
UMLS CUI [2]
C0949854
UMLS CUI [3]
C0025219
psychotherapy of any type
Description

Psychotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0033968
female patients of childbearing potential who are not using effective contraception
Description

Childbearing Potential Contraceptive methods Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332268
other protocol-defined inclusion/exclusion criteria may apply
Description

Clinical Trial Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Major Depressive Disorder NCT00411099

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Single major depressive episode | Recurrent major depressive episode
Item
diagnosis of major depressive disorder, single or recurrent episode, according to dsm-iv criteria
boolean
C0024517 (UMLS CUI [1])
C0154409 (UMLS CUI [2])
Hamilton Depression Rating Scale 17 Item Questionnaire
Item
ham-d17 total score > or = 22 at screening and baseline
boolean
C3639712 (UMLS CUI [1])
Clinical Global Impression Questionnaire
Item
cgi-severity score > or = 4 at screening and baseline
boolean
C3639708 (UMLS CUI [1])
Protocol Compliance Complete | Participation Open Label Study
Item
only patients who complete the core protocol are eligible to participate in the open-label extension phase
boolean
C0525058 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0679823 (UMLS CUI [2,1])
C1709323 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Bipolar I disorder | Bipolar II disorder | Schizophrenia | Schizoaffective Disorder | Eating Disorders | Obsessive-Compulsive Disorder
Item
history of bipolar disorder (i or ii), schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder
boolean
C0853193 (UMLS CUI [1])
C0236788 (UMLS CUI [2])
C0036341 (UMLS CUI [3])
C0036337 (UMLS CUI [4])
C0013473 (UMLS CUI [5])
C0028768 (UMLS CUI [6])
Axis I diagnosis | Major Depressive Disorder
Item
any current axis i disorder other than major depressive disorder which is the focus of treatment
boolean
C0270287 (UMLS CUI [1])
C1269683 (UMLS CUI [2])
Substance Use Disorders | Substance Dependence
Item
substance or alcohol abuse in the last 30 days, dependence in the last 6 months
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Psychotropic Drugs | Plant Preparations | Melatonin
Item
concomitant psychotropic medication, including herbal preparations and melatonin
boolean
C0033978 (UMLS CUI [1])
C0949854 (UMLS CUI [2])
C0025219 (UMLS CUI [3])
Psychotherapy
Item
psychotherapy of any type
boolean
C0033968 (UMLS CUI [1])
Childbearing Potential Contraceptive methods Lacking
Item
female patients of childbearing potential who are not using effective contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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