ID

18064

Beschrijving

The Effectiveness of Sertraline in Patients Who Have Had Inadequate Response to Escitalopram; ODM derived from: https://clinicaltrials.gov/show/NCT00179257

Link

https://clinicaltrials.gov/show/NCT00179257

Trefwoorden

Versies (1)
  1. 18-10-16 18-10-16 -
Geüploaded op

18 oktober 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00179257

Engels

Eligibility Major Depressive Disorder NCT00179257

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
primary dsm-iv diagnosis of major depressive episode of mdd without psychotic symptoms. additional axis i diagnoses will be permitted only if they are identified as secondary diagnoses
Beschrijving

major depressive episode | Major Depressive Disorder | Psychotic symptom | Axis I diagnosis Secondary

Datatype

boolean

Alias
UMLS CUI [1]
C0024517
UMLS CUI [2]
C1269683
UMLS CUI [3]
C0871189
UMLS CUI [4,1]
C0270287
UMLS CUI [4,2]
C0332138
ham-d 21 item score of greater than or equal to 18
Beschrijving

Hamilton rating scale for depression

Datatype

boolean

Alias
UMLS CUI [1]
C0451203
age 18 and above
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
ability and willingness to provide consent for participation
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
failure to respond to escitalopram
Beschrijving

Escitalopram Unresponsive to Treatment

Datatype

boolean

Alias
UMLS CUI [1,1]
C1099456
UMLS CUI [1,2]
C0205269
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosis of bipolar disorder or any psychotic disorder
Beschrijving

Bipolar Disorder | Psychotic Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0005586
UMLS CUI [2]
C0033975
alcohol or drug abuse or dependence currently or in the last 6 months
Beschrijving

Substance Use Disorders | Substance Dependence

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
a history of non-response or intolerance to sertraline at least 50 mg. for at least 4 weeks or more
Beschrijving

Sertraline Dosage Unresponsive to Treatment | intolerance to Sertraline Dosage

Datatype

boolean

Alias
UMLS CUI [1,1]
C0074393
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205269
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0074393
UMLS CUI [2,3]
C0178602
concomitant use of another antidepressant or use of an antidepressant within 2 weeks of baseline (4 weeks for fluoxetine)
Beschrijving

Antidepressive Agents | Fluoxetine

Datatype

boolean

Alias
UMLS CUI [1]
C0003289
UMLS CUI [2]
C0016365
use within 1 week of baseline, or concomitant use of any psychotropics with the exception of zolpidem for sleep
Beschrijving

Psychotropic Drugs Sleep | zolpidem Sleep

Datatype

boolean

Alias
UMLS CUI [1,1]
C0033978
UMLS CUI [1,2]
C0037313
UMLS CUI [2,1]
C0078839
UMLS CUI [2,2]
C0037313
use within 4 weeks of baseline or concomitant use of benzodiazepines with the exception of prn use of diazepam 10 mg/day or its equivalent
Beschrijving

Benzodiazepines | Diazepam U/day PRN medicine | Diazepam Equivalent

Datatype

boolean

Alias
UMLS CUI [1]
C0005064
UMLS CUI [2,1]
C0012010
UMLS CUI [2,2]
C0456683
UMLS CUI [2,3]
C3166225
UMLS CUI [3,1]
C0012010
UMLS CUI [3,2]
C0205163
presence of serious and/or unstable medical condition
Beschrijving

Medical condition Serious | Medical condition Unstable

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0443343
score of 3 or 4 on the suicide item (item 3) of the ham-d scale
Beschrijving

Suicide Item | Hamilton rating scale for depression

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038661
UMLS CUI [1,2]
C1551338
UMLS CUI [2]
C0451203
known sensitivity of sertraline
Beschrijving

Hypersensitivity Sertraline

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0074393
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Similar models

Eligibility Major Depressive Disorder NCT00179257

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
major depressive episode | Major Depressive Disorder | Psychotic symptom | Axis I diagnosis Secondary
Item
primary dsm-iv diagnosis of major depressive episode of mdd without psychotic symptoms. additional axis i diagnoses will be permitted only if they are identified as secondary diagnoses
boolean
C0024517 (UMLS CUI [1])
C1269683 (UMLS CUI [2])
C0871189 (UMLS CUI [3])
C0270287 (UMLS CUI [4,1])
C0332138 (UMLS CUI [4,2])
Hamilton rating scale for depression
Item
ham-d 21 item score of greater than or equal to 18
boolean
C0451203 (UMLS CUI [1])
Age
Item
age 18 and above
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
ability and willingness to provide consent for participation
boolean
C0021430 (UMLS CUI [1])
Escitalopram Unresponsive to Treatment
Item
failure to respond to escitalopram
boolean
C1099456 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Bipolar Disorder | Psychotic Disorders
Item
diagnosis of bipolar disorder or any psychotic disorder
boolean
C0005586 (UMLS CUI [1])
C0033975 (UMLS CUI [2])
Substance Use Disorders | Substance Dependence
Item
alcohol or drug abuse or dependence currently or in the last 6 months
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Sertraline Dosage Unresponsive to Treatment | intolerance to Sertraline Dosage
Item
a history of non-response or intolerance to sertraline at least 50 mg. for at least 4 weeks or more
boolean
C0074393 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205269 (UMLS CUI [1,3])
C1744706 (UMLS CUI [2,1])
C0074393 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
Antidepressive Agents | Fluoxetine
Item
concomitant use of another antidepressant or use of an antidepressant within 2 weeks of baseline (4 weeks for fluoxetine)
boolean
C0003289 (UMLS CUI [1])
C0016365 (UMLS CUI [2])
Psychotropic Drugs Sleep | zolpidem Sleep
Item
use within 1 week of baseline, or concomitant use of any psychotropics with the exception of zolpidem for sleep
boolean
C0033978 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
C0078839 (UMLS CUI [2,1])
C0037313 (UMLS CUI [2,2])
Benzodiazepines | Diazepam U/day PRN medicine | Diazepam Equivalent
Item
use within 4 weeks of baseline or concomitant use of benzodiazepines with the exception of prn use of diazepam 10 mg/day or its equivalent
boolean
C0005064 (UMLS CUI [1])
C0012010 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C3166225 (UMLS CUI [2,3])
C0012010 (UMLS CUI [3,1])
C0205163 (UMLS CUI [3,2])
Medical condition Serious | Medical condition Unstable
Item
presence of serious and/or unstable medical condition
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
Suicide Item | Hamilton rating scale for depression
Item
score of 3 or 4 on the suicide item (item 3) of the ham-d scale
boolean
C0038661 (UMLS CUI [1,1])
C1551338 (UMLS CUI [1,2])
C0451203 (UMLS CUI [2])
Hypersensitivity Sertraline
Item
known sensitivity of sertraline
boolean
C0020517 (UMLS CUI [1,1])
C0074393 (UMLS CUI [1,2])
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