ID

30510

Description

Duloxetine for Major Depression in Peri-/Postmenopausal Women; ODM derived from: https://clinicaltrials.gov/show/NCT00889369

Link

https://clinicaltrials.gov/show/NCT00889369

Keywords

Versions (1)
  1. 6/10/18 6/10/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 10, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00889369

English

Eligibility Major Depressive Disorder NCT00889369

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
peri-/postmenopausal women, aged 40-60 year
Description

Perimenopausal state | Postmenopausal state | Age

Data type

boolean

Alias
UMLS CUI [1]
C3839366
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0001779
moderate to severe major depressive episode
Description

Moderate major depressive episode | Major depressive disorder, Single episode, Severe

Data type

boolean

Alias
UMLS CUI [1]
C0154404
UMLS CUI [2]
C4237172
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
dsm-iv axis i diagnosis other than mdd
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
contraindications to magnetic resonance imaging
Description

Medical contraindication Magnetic Resonance Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
treatment-resistent
Description

Unresponsive to Treatment

Data type

boolean

Alias
UMLS CUI [1]
C0205269
previous failed treatment with duloxetine
Description

Prior Therapy failed | Duloxetine

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0231175
UMLS CUI [2]
C0245561
history of substance abuse or dependence in past year
Description

Substance Use Disorders | Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
serious suicidal risk
Description

At risk for suicide Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0563664
UMLS CUI [1,2]
C0205404
use of other psychotropic medications
Description

Psychotropic Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0033978
electroconvulsive therapy or transmagnetic stimulation in past year
Description

Electroconvulsive Therapy | Transcranial magnetic stimulation

Data type

boolean

Alias
UMLS CUI [1]
C0013806
UMLS CUI [2]
C0436548
history of allergic reactions to duloxetine
Description

Allergic Reaction Duloxetine

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0245561
significant laboratory abnormalities at baseline
Description

Laboratory test result abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0438215
severe hepatic impairment
Description

Hepatic impairment Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0948807
UMLS CUI [1,2]
C0205082
end stage renal disease and undergoing dialysis
Description

Kidney Failure, Chronic | Dialysis

Data type

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2]
C0011946
uncontrolled narrow-angle glaucoma
Description

Angle Closure Glaucoma Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0017605
UMLS CUI [1,2]
C0205318
uncontrolled or untreated hyper-/hypothyroidism, or abnormal thyroid stimulating hormone concentration
Description

Hyperthyroidism Uncontrolled | Hypothyroidism Uncontrolled | Hyperthyroidism untreated | Hypothyroidism (if untreated) | Serum TSH level abnormal

Data type

boolean

Alias
UMLS CUI [1,1]
C0020550
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0020676
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0020550
UMLS CUI [3,2]
C0332155
UMLS CUI [4]
C2749407
UMLS CUI [5]
C0580434
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Similar models

Eligibility Major Depressive Disorder NCT00889369

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Perimenopausal state | Postmenopausal state | Age
Item
peri-/postmenopausal women, aged 40-60 year
boolean
C3839366 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Moderate major depressive episode | Major depressive disorder, Single episode, Severe
Item
moderate to severe major depressive episode
boolean
C0154404 (UMLS CUI [1])
C4237172 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Axis I diagnosis | Exception Major Depressive Disorder
Item
dsm-iv axis i diagnosis other than mdd
boolean
C0270287 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1269683 (UMLS CUI [2,2])
Medical contraindication Magnetic Resonance Imaging
Item
contraindications to magnetic resonance imaging
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
Unresponsive to Treatment
Item
treatment-resistent
boolean
C0205269 (UMLS CUI [1])
Prior Therapy failed | Duloxetine
Item
previous failed treatment with duloxetine
boolean
C1514463 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0245561 (UMLS CUI [2])
Substance Use Disorders | Substance Dependence
Item
history of substance abuse or dependence in past year
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
At risk for suicide Serious
Item
serious suicidal risk
boolean
C0563664 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Psychotropic Drugs
Item
use of other psychotropic medications
boolean
C0033978 (UMLS CUI [1])
Electroconvulsive Therapy | Transcranial magnetic stimulation
Item
electroconvulsive therapy or transmagnetic stimulation in past year
boolean
C0013806 (UMLS CUI [1])
C0436548 (UMLS CUI [2])
Allergic Reaction Duloxetine
Item
history of allergic reactions to duloxetine
boolean
C1527304 (UMLS CUI [1,1])
C0245561 (UMLS CUI [1,2])
Laboratory test result abnormal
Item
significant laboratory abnormalities at baseline
boolean
C0438215 (UMLS CUI [1])
Hepatic impairment Severe
Item
severe hepatic impairment
boolean
C0948807 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Kidney Failure, Chronic | Dialysis
Item
end stage renal disease and undergoing dialysis
boolean
C0022661 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
Angle Closure Glaucoma Uncontrolled
Item
uncontrolled narrow-angle glaucoma
boolean
C0017605 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Hyperthyroidism Uncontrolled | Hypothyroidism Uncontrolled | Hyperthyroidism untreated | Hypothyroidism (if untreated) | Serum TSH level abnormal
Item
uncontrolled or untreated hyper-/hypothyroidism, or abnormal thyroid stimulating hormone concentration
boolean
C0020550 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0020676 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0020550 (UMLS CUI [3,1])
C0332155 (UMLS CUI [3,2])
C2749407 (UMLS CUI [4])
C0580434 (UMLS CUI [5])
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