ID

44436

Description

Efficacy and Safety of Escitalopram Doses up to 50mg in Treatment of MDD; ODM derived from: https://clinicaltrials.gov/show/NCT00785434

Lien

https://clinicaltrials.gov/show/NCT00785434

Mots-clés

  1. 09/06/2018 09/06/2018 -
  2. 20/09/2021 20/09/2021 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

20 septembre 2021

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Major Depressive Disorder NCT00785434

Eligibility Major Depressive Disorder NCT00785434

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent will be obtained from each patient
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
aged 18 to 65 inc
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
suffering from mdd as defined by dsm iv
Description

Major Depressive Disorder

Type de données

boolean

Alias
UMLS CUI [1]
C1269683
have been taking citalopram in a dose of at least 20mg for at least six weeks
Description

Citalopram Dosage

Type de données

boolean

Alias
UMLS CUI [1,1]
C0008845
UMLS CUI [1,2]
C0178602
an inadequate response -- defined as failure to achieve a madrs score of <12
Description

Disease Response Inadequate Montgomery-Asberg Depression Rating Scale Questionnaire

Type de données

boolean

Alias
UMLS CUI [1,1]
C1704632
UMLS CUI [1,2]
C0205412
UMLS CUI [1,3]
C4054475
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
significant other psychiatric disorder which would interfere with trial assessments. co-morbid generalized anxiety disorder (gad) and panic will be permitted where mdd is considered the primary diagnosis .
Description

Mental disorder Interferes with Assessment | Comorbid Generalized Anxiety Disorder allowed | Comorbid mental disorder Panic allowed

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1516048
UMLS CUI [2,1]
C4540884
UMLS CUI [2,2]
C0270549
UMLS CUI [2,3]
C0683607
UMLS CUI [3,1]
C4540884
UMLS CUI [3,2]
C0030318
UMLS CUI [3,3]
C0683607
history of mania or bipolar disorder
Description

Manic Disorder | Bipolar Disorder

Type de données

boolean

Alias
UMLS CUI [1]
C0024713
UMLS CUI [2]
C0005586
known contraindication for the use of citalopram or escitalopram.
Description

Medical contraindication Citalopram | Medical contraindication Escitalopram

Type de données

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0008845
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C1099456
significant bleeding disorder
Description

Blood Coagulation Disorders

Type de données

boolean

Alias
UMLS CUI [1]
C0005779
prominent suicidal ideation (score more than 4 in the madrs "suicidal thoughts" item)
Description

Feeling suicidal Montgomery-Asberg Depression Rating Scale Questionnaire

Type de données

boolean

Alias
UMLS CUI [1,1]
C0424000
UMLS CUI [1,2]
C4054475
alcohol or substance dependence in the past 6 months
Description

Substance Dependence

Type de données

boolean

Alias
UMLS CUI [1]
C0038580
major physical illness
Description

Physical illness Major

Type de données

boolean

Alias
UMLS CUI [1,1]
C0683323
UMLS CUI [1,2]
C0205164
significant liver or renal function abnormality
Description

Liver Dysfunction | Abnormal renal function

Type de données

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151746
significant ecg abnormalities
Description

ECG abnormality

Type de données

boolean

Alias
UMLS CUI [1]
C0522055
pregnant or lactating females
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
inadequate contraception
Description

Contraceptive methods Inadequate

Type de données

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0205412

Similar models

Eligibility Major Depressive Disorder NCT00785434

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
written informed consent will be obtained from each patient
boolean
C0021430 (UMLS CUI [1])
Age
Item
aged 18 to 65 inc
boolean
C0001779 (UMLS CUI [1])
Major Depressive Disorder
Item
suffering from mdd as defined by dsm iv
boolean
C1269683 (UMLS CUI [1])
Citalopram Dosage
Item
have been taking citalopram in a dose of at least 20mg for at least six weeks
boolean
C0008845 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Disease Response Inadequate Montgomery-Asberg Depression Rating Scale Questionnaire
Item
an inadequate response -- defined as failure to achieve a madrs score of <12
boolean
C1704632 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C4054475 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Mental disorder Interferes with Assessment | Comorbid Generalized Anxiety Disorder allowed | Comorbid mental disorder Panic allowed
Item
significant other psychiatric disorder which would interfere with trial assessments. co-morbid generalized anxiety disorder (gad) and panic will be permitted where mdd is considered the primary diagnosis .
boolean
C0004936 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C4540884 (UMLS CUI [2,1])
C0270549 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C4540884 (UMLS CUI [3,1])
C0030318 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
Manic Disorder | Bipolar Disorder
Item
history of mania or bipolar disorder
boolean
C0024713 (UMLS CUI [1])
C0005586 (UMLS CUI [2])
Medical contraindication Citalopram | Medical contraindication Escitalopram
Item
known contraindication for the use of citalopram or escitalopram.
boolean
C1301624 (UMLS CUI [1,1])
C0008845 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C1099456 (UMLS CUI [2,2])
Blood Coagulation Disorders
Item
significant bleeding disorder
boolean
C0005779 (UMLS CUI [1])
Feeling suicidal Montgomery-Asberg Depression Rating Scale Questionnaire
Item
prominent suicidal ideation (score more than 4 in the madrs "suicidal thoughts" item)
boolean
C0424000 (UMLS CUI [1,1])
C4054475 (UMLS CUI [1,2])
Substance Dependence
Item
alcohol or substance dependence in the past 6 months
boolean
C0038580 (UMLS CUI [1])
Physical illness Major
Item
major physical illness
boolean
C0683323 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
Liver Dysfunction | Abnormal renal function
Item
significant liver or renal function abnormality
boolean
C0086565 (UMLS CUI [1])
C0151746 (UMLS CUI [2])
ECG abnormality
Item
significant ecg abnormalities
boolean
C0522055 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or lactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Contraceptive methods Inadequate
Item
inadequate contraception
boolean
C0700589 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])

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