ID

31505

Description

Escitalopram (Lexapro) for the Treatment of Postpartum Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00833469

Link

https://clinicaltrials.gov/show/NCT00833469

Keywords

Versions (1)
  1. 8/29/18 8/29/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 29, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Postpartum Depression NCT00833469

English

Eligibility Postpartum Depression NCT00833469

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women ages 18 to 45 years old
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
subjects must meet criteria for a major depressive episode with symptoms developing within three month of live childbirth
Description

Major depressive episode | Symptom Onset Time Period Childbirth

Data type

boolean

Alias
UMLS CUI [1]
C0024517
UMLS CUI [2,1]
C4086878
UMLS CUI [2,2]
C1948053
UMLS CUI [2,3]
C1148523
subjects must present within six months of childbirth
Description

Study Subject Time Period Childbirth

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1948053
UMLS CUI [1,3]
C1148523
madrs score >15
Description

Montgomery-Asberg Depression Rating Scale Questionnaire

Data type

boolean

Alias
UMLS CUI [1]
C4054475
bai score >10
Description

Beck Anxiety Inventory score

Data type

boolean

Alias
UMLS CUI [1]
C4274492
subjects will be able to be treated on an outpatient basis
Description

Therapeutic procedure Outpatient

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0029921
subjects will be able to provide written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects who have taken any psychotropic medication, including antidepressants and anti-anxiety medication, within the past two weeks (with the exception of non-benzodiazepine medications used for sleep, including trazodone, zolpidem, eszopiclone, etc)
Description

Psychotropic Drugs | Antidepressive Agents | Anti-Anxiety Agents | Exception Sedative hypnotics (non-benzodiazepines) | Exception Trazodone | Exception Zolpidem | Exception Eszopiclone

Data type

boolean

Alias
UMLS CUI [1]
C0033978
UMLS CUI [2]
C0003289
UMLS CUI [3]
C0040616
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C3854290
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0040805
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0078839
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C1436328
suicidal ideation with active plan or intent, as determined by the investigator
Description

Feeling suicidal | Planning suicide | Suicidal intent

Data type

boolean

Alias
UMLS CUI [1]
C0424000
UMLS CUI [2]
C0424001
UMLS CUI [3]
C0582496
presence of psychotic symptoms or homicidal ideation
Description

Psychotic symptom | Homicidal thoughts

Data type

boolean

Alias
UMLS CUI [1]
C0871189
UMLS CUI [2]
C0455204
history of mania or hypomania
Description

Mania | Hypomania

Data type

boolean

Alias
UMLS CUI [1]
C0338831
UMLS CUI [2]
C0241934
pregnant or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
presence of chronic depression or dysthymia, or chronic or treatment resistant anxiety disorders, as determined by investigator
Description

Chronic depression | Dysthymic Disorder chronic | Chronic anxiety | Anxiety Disorders Unresponsive to Treatment

Data type

boolean

Alias
UMLS CUI [1]
C0581391
UMLS CUI [2,1]
C0013415
UMLS CUI [2,2]
C0205191
UMLS CUI [3]
C0581386
UMLS CUI [4,1]
C0003469
UMLS CUI [4,2]
C0205269
active alcohol/substance abuse currently or within the past year
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
abnormal tsh, severe anemia, or uncontrolled hypertension
Description

Blood thyroid stimulating hormone abnormal | Anemia, severe | Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0853625
UMLS CUI [2]
C0238644
UMLS CUI [3]
C1868885
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Similar models

Eligibility Postpartum Depression NCT00833469

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
women ages 18 to 45 years old
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Major depressive episode | Symptom Onset Time Period Childbirth
Item
subjects must meet criteria for a major depressive episode with symptoms developing within three month of live childbirth
boolean
C0024517 (UMLS CUI [1])
C4086878 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C1148523 (UMLS CUI [2,3])
Study Subject Time Period Childbirth
Item
subjects must present within six months of childbirth
boolean
C0681850 (UMLS CUI [1,1])
C1948053 (UMLS CUI [1,2])
C1148523 (UMLS CUI [1,3])
Montgomery-Asberg Depression Rating Scale Questionnaire
Item
madrs score >15
boolean
C4054475 (UMLS CUI [1])
Beck Anxiety Inventory score
Item
bai score >10
boolean
C4274492 (UMLS CUI [1])
Therapeutic procedure Outpatient
Item
subjects will be able to be treated on an outpatient basis
boolean
C0087111 (UMLS CUI [1,1])
C0029921 (UMLS CUI [1,2])
Informed Consent
Item
subjects will be able to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Psychotropic Drugs | Antidepressive Agents | Anti-Anxiety Agents | Exception Sedative hypnotics (non-benzodiazepines) | Exception Trazodone | Exception Zolpidem | Exception Eszopiclone
Item
subjects who have taken any psychotropic medication, including antidepressants and anti-anxiety medication, within the past two weeks (with the exception of non-benzodiazepine medications used for sleep, including trazodone, zolpidem, eszopiclone, etc)
boolean
C0033978 (UMLS CUI [1])
C0003289 (UMLS CUI [2])
C0040616 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C3854290 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0040805 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0078839 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C1436328 (UMLS CUI [7,2])
Feeling suicidal | Planning suicide | Suicidal intent
Item
suicidal ideation with active plan or intent, as determined by the investigator
boolean
C0424000 (UMLS CUI [1])
C0424001 (UMLS CUI [2])
C0582496 (UMLS CUI [3])
Psychotic symptom | Homicidal thoughts
Item
presence of psychotic symptoms or homicidal ideation
boolean
C0871189 (UMLS CUI [1])
C0455204 (UMLS CUI [2])
Mania | Hypomania
Item
history of mania or hypomania
boolean
C0338831 (UMLS CUI [1])
C0241934 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Chronic depression | Dysthymic Disorder chronic | Chronic anxiety | Anxiety Disorders Unresponsive to Treatment
Item
presence of chronic depression or dysthymia, or chronic or treatment resistant anxiety disorders, as determined by investigator
boolean
C0581391 (UMLS CUI [1])
C0013415 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0581386 (UMLS CUI [3])
C0003469 (UMLS CUI [4,1])
C0205269 (UMLS CUI [4,2])
Substance Use Disorders
Item
active alcohol/substance abuse currently or within the past year
boolean
C0038586 (UMLS CUI [1])
Blood thyroid stimulating hormone abnormal | Anemia, severe | Uncontrolled hypertension
Item
abnormal tsh, severe anemia, or uncontrolled hypertension
boolean
C0853625 (UMLS CUI [1])
C0238644 (UMLS CUI [2])
C1868885 (UMLS CUI [3])
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