ID

24581

Description

Efficacy, Safety and Tolerability of Agomelatine in the Prevention of Relapse of Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT00467402

Link

https://clinicaltrials.gov/show/NCT00467402

Keywords

  1. 8/7/17 8/7/17 -
Uploaded on

August 7, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Major Depressive Disorder NCT00467402

Eligibility Major Depressive Disorder NCT00467402

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female adults, 18 through 70 years of age, inclusive
Description

Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
diagnosis of major depressive disorder, recurrent episode, according to diagnostic and statistical manual of mental disorders - 4th edition (dsm-iv) criteria
Description

Major Depressive Disorder Recurrent episode

Data type

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0443287
a history of at least two previous episodes of major depression plus the current episode
Description

Single major depressive episode Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0024517
UMLS CUI [1,2]
C1265611
hamilton depression rating scale (ham-d17) total score ≥ 22 at screening and baseline
Description

Hamilton rating scale for depression

Data type

boolean

Alias
UMLS CUI [1]
C0451203
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 | Exception Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0270287
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
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
use of any psychoactive medication after the screening visit
Description

Psychotropic Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0033978
patients who have been previously treated with agomelatine
Description

Agomelatine

Data type

boolean

Alias
UMLS CUI [1]
C0971637
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

Similar models

Eligibility Major Depressive Disorder NCT00467402

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
male and female adults, 18 through 70 years of age, inclusive
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Major Depressive Disorder Recurrent episode
Item
diagnosis of major depressive disorder, recurrent episode, according to diagnostic and statistical manual of mental disorders - 4th edition (dsm-iv) criteria
boolean
C1269683 (UMLS CUI [1,1])
C0443287 (UMLS CUI [1,2])
Single major depressive episode Quantity
Item
a history of at least two previous episodes of major depression plus the current episode
boolean
C0024517 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Hamilton rating scale for depression
Item
hamilton depression rating scale (ham-d17) total score ≥ 22 at screening and baseline
boolean
C0451203 (UMLS CUI [1])
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 | Exception 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])
C1705847 (UMLS CUI [2,1])
C1269683 (UMLS CUI [2,2])
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
Item
use of any psychoactive medication after the screening visit
boolean
C0033978 (UMLS CUI [1])
Agomelatine
Item
patients who have been previously treated with agomelatine
boolean
C0971637 (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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