ID

21817

Description

Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder (SIRIUS); ODM derived from: https://clinicaltrials.gov/show/NCT00385307

Lien

https://clinicaltrials.gov/show/NCT00385307

Mots-clés

Versions (1)
  1. 02/05/2017 02/05/2017 -
Téléchargé le

2 mai 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00385307

Anglais

Eligibility Major Depressive Disorder NCT00385307

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient with major depressive disorder diagnosed according to diagnostic and statistical manual of mental disorders dsm-iv-tr
Description

Major Depressive Disorder

Type de données

boolean

Alias
UMLS CUI [1]
C1269683
patient meets criteria for a recurrent major depressive episode (mde)
Description

Recurrent major depressive episode

Type de données

boolean

Alias
UMLS CUI [1]
C0154409
patient meets severity assessments of depression specified by the study
Description

Depressive disorder Severity Assessment | Severity Specified Study Protocol

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011581
UMLS CUI [1,2]
C0439793
UMLS CUI [1,3]
C1516048
UMLS CUI [2,1]
C0439793
UMLS CUI [2,2]
C0205369
UMLS CUI [2,3]
C2348563
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient is at immediate risk for suicidal behavior
Description

Suicidal behavior At risk Immediate

Type de données

boolean

Alias
UMLS CUI [1,1]
C1760428
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0205253
patient is with a unstable medical condition
Description

Medical condition Unstable

Type de données

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
patient with psychotic features, catatonic features, seasonal pattern or postpartum onset
Description

Psychotic symptom | Feature Catatonic | Seasonal Affective Disorder | Depression, Postpartum

Type de données

boolean

Alias
UMLS CUI [1]
C0871189
UMLS CUI [2,1]
C2348519
UMLS CUI [2,2]
C0007398
UMLS CUI [3]
C0085159
UMLS CUI [4]
C0221074
patient has taken concomitant treatment that may interfere with valid collection or interpretation of study data
Description

Therapeutic procedure Interferes with Study data | Therapeutic procedure Interferes with Study data Interpretation

Type de données

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0681873
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0681873
UMLS CUI [2,4]
C0459471
patient has been treated with non-pharmacologic therapy intended to treat depression in the past 6 months
Description

Therapeutic procedure Depressive disorder | Pharmaceutical Preparations Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0011581
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0332197
patient has been treated with paroxetine (paxil) within the previous 6 months
Description

Paroxetine | Paxil

Type de données

boolean

Alias
UMLS CUI [1]
C0070122
UMLS CUI [2]
C0376414
patient is pregnant or breastfeeding, or likely to become pregnant during the course of the study
Description

Pregnancy | Breast Feeding | Pregnancy Expected

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C1517001
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Similar models

Eligibility Major Depressive Disorder NCT00385307

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder
Item
patient with major depressive disorder diagnosed according to diagnostic and statistical manual of mental disorders dsm-iv-tr
boolean
C1269683 (UMLS CUI [1])
Recurrent major depressive episode
Item
patient meets criteria for a recurrent major depressive episode (mde)
boolean
C0154409 (UMLS CUI [1])
Depressive disorder Severity Assessment | Severity Specified Study Protocol
Item
patient meets severity assessments of depression specified by the study
boolean
C0011581 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C0439793 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
C2348563 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Suicidal behavior At risk Immediate
Item
patient is at immediate risk for suicidal behavior
boolean
C1760428 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0205253 (UMLS CUI [1,3])
Medical condition Unstable
Item
patient is with a unstable medical condition
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Psychotic symptom | Feature Catatonic | Seasonal Affective Disorder | Depression, Postpartum
Item
patient with psychotic features, catatonic features, seasonal pattern or postpartum onset
boolean
C0871189 (UMLS CUI [1])
C2348519 (UMLS CUI [2,1])
C0007398 (UMLS CUI [2,2])
C0085159 (UMLS CUI [3])
C0221074 (UMLS CUI [4])
Therapeutic procedure Interferes with Study data | Therapeutic procedure Interferes with Study data Interpretation
Item
patient has taken concomitant treatment that may interfere with valid collection or interpretation of study data
boolean
C0087111 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0681873 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0681873 (UMLS CUI [2,3])
C0459471 (UMLS CUI [2,4])
Therapeutic procedure Depressive disorder | Pharmaceutical Preparations Absent
Item
patient has been treated with non-pharmacologic therapy intended to treat depression in the past 6 months
boolean
C0087111 (UMLS CUI [1,1])
C0011581 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Paroxetine | Paxil
Item
patient has been treated with paroxetine (paxil) within the previous 6 months
boolean
C0070122 (UMLS CUI [1])
C0376414 (UMLS CUI [2])
Pregnancy | Breast Feeding | Pregnancy Expected
Item
patient is pregnant or breastfeeding, or likely to become pregnant during the course of the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1517001 (UMLS CUI [3,2])
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