ID

30477

Description

A Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and Tolerability of Agomelatine (25 or 50 mg) in the Treatment of Major Depressive Disorder (MDD); ODM derived from: https://clinicaltrials.gov/show/NCT00463242

Lien

https://clinicaltrials.gov/show/NCT00463242

Mots-clés

  1. 07/06/2018 07/06/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

7 juin 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Major Depressive Disorder NCT00463242

Eligibility Major Depressive Disorder NCT00463242

Inclusion Criteria
Description

Inclusion Criteria

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

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of major depressive disorder according to dsm-iv criteria
Description

Major Depressive Disorder

Type de données

boolean

Alias
UMLS CUI [1]
C1269683
ham-d17 total score > or = 22 at screening and baseline
Description

Hamilton Depression Rating Scale 17 Item Clinical Classification

Type de données

boolean

Alias
UMLS CUI [1]
C3639712
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of non-response to paroxetine
Description

Paroxetine | Disease Response Absent

Type de données

boolean

Alias
UMLS CUI [1]
C0070122
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0332197
patients who have been previously treated with agomelatine
Description

Agomelatine

Type de données

boolean

Alias
UMLS CUI [1]
C0971637
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

Type de données

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

Type de données

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

Type de données

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
use of any psychoactive medication after the screening visit
Description

Psychotropic Drugs

Type de données

boolean

Alias
UMLS CUI [1]
C0033978
female patients of childbearing potential who are not using effective contraception
Description

Childbearing Potential Contraceptive methods Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
other protocol-defined inclusion/exclusion criteria may apply
Description

Eligibility Criteria Study Protocol

Type de données

boolean

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

Similar models

Eligibility Major Depressive Disorder NCT00463242

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male and female adults, 18 through 70 years of age, inclusive
boolean
C0001779 (UMLS CUI [1])
Major Depressive Disorder
Item
diagnosis of major depressive disorder according to dsm-iv criteria
boolean
C1269683 (UMLS CUI [1])
Hamilton Depression Rating Scale 17 Item Clinical Classification
Item
ham-d17 total score > or = 22 at screening and baseline
boolean
C3639712 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Paroxetine | Disease Response Absent
Item
history of non-response to paroxetine
boolean
C0070122 (UMLS CUI [1])
C1704632 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Agomelatine
Item
patients who have been previously treated with agomelatine
boolean
C0971637 (UMLS CUI [1])
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])
Childbearing Potential Contraceptive methods Absent
Item
female patients of childbearing potential who are not using effective contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
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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