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

Link

https://clinicaltrials.gov/show/NCT00463242

Keywords

Versions (1)
  1. 6/7/18 6/7/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 7, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00463242

English

Eligibility Major Depressive Disorder NCT00463242

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Age

Data type

boolean

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

Major Depressive Disorder

Data type

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

Data type

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

Data type

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

Data type

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

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
female patients of childbearing potential who are not using effective contraception
Description

Childbearing Potential Contraceptive methods Absent

Data type

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

Data type

boolean

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

Eligibility Major Depressive Disorder NCT00463242

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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