ID

22308

Beskrivning

Memantine Plus Es-citalopram in Elderly Depressed Patients With Cognitive Impairment; ODM derived from: https://clinicaltrials.gov/show/NCT01876823

Länk

https://clinicaltrials.gov/show/NCT01876823

Nyckelord

Versioner (1)
  1. 2017-05-29 2017-05-29 -
Uppladdad den

29 maj 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Mild Cognitive Impairment NCT01876823

Engelsk

Eligibility Mild Cognitive Impairment NCT01876823

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. of either sex, age greater than 49 years old
Beskrivning

age, gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
2. meets criteria for both "depression" and "cognitive impairment".
Beskrivning

depression, cognitive impairment

Datatyp

boolean

Alias
UMLS CUI [1]
C0011581
UMLS CUI [2]
C0338656
3. study criteria for "depression":
Beskrivning

study criteria, depression

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011581
UMLS CUI [1,2]
C1516637
i. patients who meet dsm-iv criteria for major depression, dysthymic disorder, or dysthymia symptoms criteria of minimum 6 month duration (not the 2 year dsm-iv criteria). ii. 24-item ham-d greater than 13; and iii. clinical global impression (cgi) for severity of depression greater than 2 (absolute score at least mild to moderate depression on a 7-point scale)
Beskrivning

dsm-iv criteria major depression or dysthymic disorder, Hamilton rating scale for depression, clinical global impression (cgi) for severity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0220952
UMLS CUI [1,2]
C1269683
UMLS CUI [2,1]
C0220952
UMLS CUI [2,2]
C0013415
UMLS CUI [3]
C0451203
UMLS CUI [4,1]
C3639708
UMLS CUI [4,2]
C3639887
4. study criteria for "cognitive deficit":
Beskrivning

cognitive deficit

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009241
UMLS CUI [1,2]
C1516637
i. subjective memory complaint ii.mini mental status exam (mmse) greater than 24; and at least one of a, b, or c:
Beskrivning

subjective memory complaint

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0439655
UMLS CUI [1,2]
C0233794
UMLS CUI [2]
C0451306
1. less than 3 on mmse 5 min delay on recall
Beskrivning

MMSE Question 5

Datatyp

boolean

Alias
UMLS CUI [1]
C3639519
2. scores on 2 neuropsychological tests greater than 1 standard deviation (sd) below standardized norms, or
Beskrivning

neuropsychological tests, standard deviation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027902
UMLS CUI [1,2]
C0871420
3. score on 1 neuropsychological tests greater than 2 sd below standardized norms.
Beskrivning

neuropsychological tests, standard deviation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027902
UMLS CUI [1,2]
C0871420
neuropsychological tests for inclusion criteria (subset of larger battery): selective reminding test with delay wechsler memory scale (wms): visual reproduction- with delay, % savings from immed to delay controlled oral word association test trails b digit symbol subtest of wechsler adult intelligence scale (wais)-iii continuous performance test iii. cgi for severity of cognitive deficit greater than 2 (absolute score on a 7-point scale:1=no deficit to 7=severe deficit). iv. clinical dementia rating (cdr) = 0 or 0.5
Beskrivning

wechsler memory scale, cgi for severity of cognitive deficit, clinical dementia rating

Datatyp

boolean

Alias
UMLS CUI [1]
C0451575
UMLS CUI [2]
C3639708
UMLS CUI [3]
C0451074
5. willing and capable of giving informed consent
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. meets criteria for dementia (dsm-iv) or probable alzheimer's disease by national institute of neurological and communicative disorders and stroke and the alzheimer's disease and related disorders association criteria (nincds-adrda criteria)
Beskrivning

dsm iv dementia, alzheimer's disease nincds-adrda

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0220952
UMLS CUI [1,2]
C0497327
UMLS CUI [2,1]
C0002395
UMLS CUI [2,2]
C2828081
Meets criteria for: 1. schizophrenia
Beskrivning

schizophrenia

Datatyp

boolean

Alias
UMLS CUI [1]
C0036341
2. alcohol or substance dependence or abuse within the last 6 months.
Beskrivning

substance use disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
3. suicidal attempt in last 6 months or current suicidal intent.
Beskrivning

suicidal attempt, suicidal intent

Datatyp

boolean

Alias
UMLS CUI [1]
C0038663
UMLS CUI [2]
C2019870
4. patients currently on an effective antidepressant medication
Beskrivning

current antidepressant medication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1096649
UMLS CUI [1,2]
C0521116
5. use of cholinesterase inhibitors in the last year.
Beskrivning

cholinesterase inhibitors

Datatyp

boolean

Alias
UMLS CUI [1]
C0008425
6. neurological disease including stroke, epilepsy, or other neurodegenerative disorders.
Beskrivning

neurological disease, stroke, epilepsy, neurodegenerative disorders

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0038454
UMLS CUI [1,3]
C0014544
UMLS CUI [1,4]
C0524851
7. an acute, severe or unstable medical condition such as metastatic or active cancer, hepatic disease, or primary renal disease requiring dialysis.
Beskrivning

comorbidity cancer, hepatic or kidney disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0006826
UMLS CUI [1,3]
C0023895
UMLS CUI [1,4]
C0022658
8. patients who can not tolerate being tapered off antidepressant medication (i.e. greater than a 25% incr. in baseline ham-d) or has a history indicating patient is unlikely to tolerate psychotropic washout.
Beskrivning

tapering off antidepressant medication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680282
UMLS CUI [1,2]
C0441640
UMLS CUI [1,3]
C0003289
9. patient with a history of non-response to citalopram or es-citalopram
Beskrivning

non-responder to citalopram or es-citalopram

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0919875
UMLS CUI [1,2]
C0008845
UMLS CUI [2,1]
C0919875
UMLS CUI [2,2]
C1099456
Tillbaka till toppen

Similar models

Eligibility Mild Cognitive Impairment NCT01876823

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
age, gender
Item
1. of either sex, age greater than 49 years old
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
depression, cognitive impairment
Item
2. meets criteria for both "depression" and "cognitive impairment".
boolean
C0011581 (UMLS CUI [1])
C0338656 (UMLS CUI [2])
study criteria, depression
Item
3. study criteria for "depression":
boolean
C0011581 (UMLS CUI [1,1])
C1516637 (UMLS CUI [1,2])
dsm-iv criteria major depression or dysthymic disorder, Hamilton rating scale for depression, clinical global impression (cgi) for severity
Item
i. patients who meet dsm-iv criteria for major depression, dysthymic disorder, or dysthymia symptoms criteria of minimum 6 month duration (not the 2 year dsm-iv criteria). ii. 24-item ham-d greater than 13; and iii. clinical global impression (cgi) for severity of depression greater than 2 (absolute score at least mild to moderate depression on a 7-point scale)
boolean
C0220952 (UMLS CUI [1,1])
C1269683 (UMLS CUI [1,2])
C0220952 (UMLS CUI [2,1])
C0013415 (UMLS CUI [2,2])
C0451203 (UMLS CUI [3])
C3639708 (UMLS CUI [4,1])
C3639887 (UMLS CUI [4,2])
cognitive deficit
Item
4. study criteria for "cognitive deficit":
boolean
C0009241 (UMLS CUI [1,1])
C1516637 (UMLS CUI [1,2])
subjective memory complaint
Item
i. subjective memory complaint ii.mini mental status exam (mmse) greater than 24; and at least one of a, b, or c:
boolean
C0439655 (UMLS CUI [1,1])
C0233794 (UMLS CUI [1,2])
C0451306 (UMLS CUI [2])
MMSE Question 5
Item
1. less than 3 on mmse 5 min delay on recall
boolean
C3639519 (UMLS CUI [1])
neuropsychological tests, standard deviation
Item
2. scores on 2 neuropsychological tests greater than 1 standard deviation (sd) below standardized norms, or
boolean
C0027902 (UMLS CUI [1,1])
C0871420 (UMLS CUI [1,2])
neuropsychological tests, standard deviation
Item
3. score on 1 neuropsychological tests greater than 2 sd below standardized norms.
boolean
C0027902 (UMLS CUI [1,1])
C0871420 (UMLS CUI [1,2])
wechsler memory scale, cgi for severity of cognitive deficit, clinical dementia rating
Item
neuropsychological tests for inclusion criteria (subset of larger battery): selective reminding test with delay wechsler memory scale (wms): visual reproduction- with delay, % savings from immed to delay controlled oral word association test trails b digit symbol subtest of wechsler adult intelligence scale (wais)-iii continuous performance test iii. cgi for severity of cognitive deficit greater than 2 (absolute score on a 7-point scale:1=no deficit to 7=severe deficit). iv. clinical dementia rating (cdr) = 0 or 0.5
boolean
C0451575 (UMLS CUI [1])
C3639708 (UMLS CUI [2])
C0451074 (UMLS CUI [3])
informed consent
Item
5. willing and capable of giving informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
dsm iv dementia, alzheimer's disease nincds-adrda
Item
1. meets criteria for dementia (dsm-iv) or probable alzheimer's disease by national institute of neurological and communicative disorders and stroke and the alzheimer's disease and related disorders association criteria (nincds-adrda criteria)
boolean
C0220952 (UMLS CUI [1,1])
C0497327 (UMLS CUI [1,2])
C0002395 (UMLS CUI [2,1])
C2828081 (UMLS CUI [2,2])
schizophrenia
Item
Meets criteria for: 1. schizophrenia
boolean
C0036341 (UMLS CUI [1])
substance use disorder
Item
2. alcohol or substance dependence or abuse within the last 6 months.
boolean
C0038586 (UMLS CUI [1])
suicidal attempt, suicidal intent
Item
3. suicidal attempt in last 6 months or current suicidal intent.
boolean
C0038663 (UMLS CUI [1])
C2019870 (UMLS CUI [2])
current antidepressant medication
Item
4. patients currently on an effective antidepressant medication
boolean
C1096649 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
cholinesterase inhibitors
Item
5. use of cholinesterase inhibitors in the last year.
boolean
C0008425 (UMLS CUI [1])
neurological disease, stroke, epilepsy, neurodegenerative disorders
Item
6. neurological disease including stroke, epilepsy, or other neurodegenerative disorders.
boolean
C0027765 (UMLS CUI [1,1])
C0038454 (UMLS CUI [1,2])
C0014544 (UMLS CUI [1,3])
C0524851 (UMLS CUI [1,4])
comorbidity cancer, hepatic or kidney disease
Item
7. an acute, severe or unstable medical condition such as metastatic or active cancer, hepatic disease, or primary renal disease requiring dialysis.
boolean
C0009488 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0023895 (UMLS CUI [1,3])
C0022658 (UMLS CUI [1,4])
tapering off antidepressant medication
Item
8. patients who can not tolerate being tapered off antidepressant medication (i.e. greater than a 25% incr. in baseline ham-d) or has a history indicating patient is unlikely to tolerate psychotropic washout.
boolean
C0680282 (UMLS CUI [1,1])
C0441640 (UMLS CUI [1,2])
C0003289 (UMLS CUI [1,3])
non-responder to citalopram or es-citalopram
Item
9. patient with a history of non-response to citalopram or es-citalopram
boolean
C0919875 (UMLS CUI [1,1])
C0008845 (UMLS CUI [1,2])
C0919875 (UMLS CUI [2,1])
C1099456 (UMLS CUI [2,2])
Tillbaka till toppen 

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