ID

22308

Descrição

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

Link

https://clinicaltrials.gov/show/NCT01876823

Palavras-chave

Versões (1)
  1. 29/05/2017 29/05/2017 -
Transferido a

29 de maio de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Mild Cognitive Impairment NCT01876823

Inglês

Eligibility Mild Cognitive Impairment NCT01876823

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

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

age, gender

Tipo de dados

boolean

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

depression, cognitive impairment

Tipo de dados

boolean

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

study criteria, depression

Tipo de dados

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)
Descrição

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

Tipo de dados

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":
Descrição

cognitive deficit

Tipo de dados

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:
Descrição

subjective memory complaint

Tipo de dados

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
Descrição

MMSE Question 5

Tipo de dados

boolean

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

neuropsychological tests, standard deviation

Tipo de dados

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.
Descrição

neuropsychological tests, standard deviation

Tipo de dados

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
Descrição

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

Tipo de dados

boolean

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

informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

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)
Descrição

dsm iv dementia, alzheimer's disease nincds-adrda

Tipo de dados

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
Descrição

schizophrenia

Tipo de dados

boolean

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

substance use disorder

Tipo de dados

boolean

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

suicidal attempt, suicidal intent

Tipo de dados

boolean

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

current antidepressant medication

Tipo de dados

boolean

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

cholinesterase inhibitors

Tipo de dados

boolean

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

neurological disease, stroke, epilepsy, neurodegenerative disorders

Tipo de dados

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.
Descrição

comorbidity cancer, hepatic or kidney disease

Tipo de dados

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.
Descrição

tapering off antidepressant medication

Tipo de dados

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
Descrição

non-responder to citalopram or es-citalopram

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0919875
UMLS CUI [1,2]
C0008845
UMLS CUI [2,1]
C0919875
UMLS CUI [2,2]
C1099456
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Similar models

Eligibility Mild Cognitive Impairment NCT01876823

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])
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