ID

13596

Descripción

Serotonergic Pharmacotherapy for Agitation of Dementia; ODM derived from: https://clinicaltrials.gov/show/NCT00009204

Link

https://clinicaltrials.gov/show/NCT00009204

Palabras clave

  1. 18/2/16 18/2/16 -
Subido en

18 de febrero de 2016

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Dementia NCT00009204

Eligibility Dementia NCT00009204

  1. StudyEvent: Eligibility
    1. Eligibility Dementia NCT00009204
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
meets dsm-iv criteria for diagnosis of dementia of the alzheimer's type (ad), vascular dementia (vd), mixed (ad and vd) or dementia nos (not otherwise specified)
Descripción

dementia of the alzheimer type (ad), vascular dementia (vd), mixed (ad and vd) or dementia nos

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0002395
UMLS CUI [2]
C0011269
UMLS CUI [3]
C3532942
UMLS CUI [4]
C0497327
presents with psychosis or behavioral problems severe enough to endanger the patient's health, well-being or safety, as evidenced by a score of at least 3 (moderate) on one of the neurobehavioral rating scale (nbrs) agitation items (8,11,14) or psychosis items (16,18,20) and are not secondary to physical illness nor amenable to environmental optimization
Descripción

psychosis or abnormal behaviour

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0033975
UMLS CUI [2]
C0233514
able to participate in study evaluations and ingest oral medication
Descripción

able to participate in study

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1321605
has next of kin or a guardian available to consent to patient's participation.
Descripción

next of kin or a guardian available

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1321605
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
has an unstable medical illness including significant cardiac (specifically bradycardia with ventricular rate below 50), renal, hepatic, or neurological illness (especially parkinson's disease) other than dementia
Descripción

unstable medical illness

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009488
meets dsm-iv criteria for delirium upon admission to western psychiatric institute and clinic
Descripción

delirium

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011206
has been medicated within 4 weeks of protocol admission with fluoxetine or 2 weeks with a monoamine oxidase inhibitor (patients will undergo a monitored psychotropic drug washout prior to entering the protocol)
Descripción

fluoxetine or monoamine oxidase inhibitor treatment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0016365
UMLS CUI [2]
C0026457
is currently being treated with cognitive enhancing drugs (tacrine or aricept) or any experimental drug
Descripción

cognitive enhancing drugs (tacrine or aricept) or any experimental drug

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0039245
UMLS CUI [2]
C0527315
UMLS CUI [3]
C0304229
has a concurrent diagnosis of schizophrenia, bipolar disorder, or major depression
Descripción

schizophrenia, bipolar disorder, or major depression

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005586
UMLS CUI [2]
C1269683
has preexisting orthostatic hypotension (with > 20 mmhg change from sitting to standing pressure)
Descripción

orthostatic hypotension

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020651

Similar models

Eligibility Dementia NCT00009204

  1. StudyEvent: Eligibility
    1. Eligibility Dementia NCT00009204
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
dementia of the alzheimer type (ad), vascular dementia (vd), mixed (ad and vd) or dementia nos
Item
meets dsm-iv criteria for diagnosis of dementia of the alzheimer's type (ad), vascular dementia (vd), mixed (ad and vd) or dementia nos (not otherwise specified)
boolean
C0002395 (UMLS CUI [1])
C0011269 (UMLS CUI [2])
C3532942 (UMLS CUI [3])
C0497327 (UMLS CUI [4])
psychosis or abnormal behaviour
Item
presents with psychosis or behavioral problems severe enough to endanger the patient's health, well-being or safety, as evidenced by a score of at least 3 (moderate) on one of the neurobehavioral rating scale (nbrs) agitation items (8,11,14) or psychosis items (16,18,20) and are not secondary to physical illness nor amenable to environmental optimization
boolean
C0033975 (UMLS CUI [1])
C0233514 (UMLS CUI [2])
able to participate in study
Item
able to participate in study evaluations and ingest oral medication
boolean
C1321605 (UMLS CUI [1])
next of kin or a guardian available
Item
has next of kin or a guardian available to consent to patient's participation.
boolean
C1321605 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
unstable medical illness
Item
has an unstable medical illness including significant cardiac (specifically bradycardia with ventricular rate below 50), renal, hepatic, or neurological illness (especially parkinson's disease) other than dementia
boolean
C0009488 (UMLS CUI [1])
delirium
Item
meets dsm-iv criteria for delirium upon admission to western psychiatric institute and clinic
boolean
C0011206 (UMLS CUI [1])
fluoxetine or monoamine oxidase inhibitor treatment
Item
has been medicated within 4 weeks of protocol admission with fluoxetine or 2 weeks with a monoamine oxidase inhibitor (patients will undergo a monitored psychotropic drug washout prior to entering the protocol)
boolean
C0016365 (UMLS CUI [1])
C0026457 (UMLS CUI [2])
cognitive enhancing drugs (tacrine or aricept) or any experimental drug
Item
is currently being treated with cognitive enhancing drugs (tacrine or aricept) or any experimental drug
boolean
C0039245 (UMLS CUI [1])
C0527315 (UMLS CUI [2])
C0304229 (UMLS CUI [3])
schizophrenia, bipolar disorder, or major depression
Item
has a concurrent diagnosis of schizophrenia, bipolar disorder, or major depression
boolean
C0005586 (UMLS CUI [1])
C1269683 (UMLS CUI [2])
orthostatic hypotension
Item
has preexisting orthostatic hypotension (with > 20 mmhg change from sitting to standing pressure)
boolean
C0020651 (UMLS CUI [1])

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