ID

44436

Description

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

Link

https://clinicaltrials.gov/show/NCT00785434

Keywords

Versions (2)
  1. 6/9/18 6/9/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00785434

English

Eligibility Major Depressive Disorder NCT00785434

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Informed Consent

Data type

boolean

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

Age

Data type

boolean

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

Major Depressive Disorder

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

boolean

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

Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038580
major physical illness
Description

Physical illness Major

Data type

boolean

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

Liver Dysfunction | Abnormal renal function

Data type

boolean

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

ECG abnormality

Data type

boolean

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

Pregnancy | Breast Feeding

Data type

boolean

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

Contraceptive methods Inadequate

Data type

boolean

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

Eligibility Major Depressive Disorder NCT00785434

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