ID

14184

Description

The Depression in Alzheimer's Disease Study (DIADS); ODM derived from: https://clinicaltrials.gov/show/NCT00009191

Lien

https://clinicaltrials.gov/show/NCT00009191

Mots-clés

  1. 03/04/2016 03/04/2016 -
Téléchargé le

3 avril 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Alzheimer Disease NCT00009191

Eligibility Alzheimer Disease NCT00009191

Criteria
Description

Criteria

diagnosis of probable alzheimer's disease (ad) by nincds/adrda criteria (mckann et al., 1984), with a mmse score greater than 10
Description

alzheimers disease

Type de données

boolean

Alias
UMLS CUI [1]
C0002395
diagnosis of current major depressive episode (md), by dsm-iv, based on the scid-iv examination
Description

major depressive episode

Type de données

boolean

Alias
UMLS CUI [1]
C0024517
patients will be included even if they have a pre-ad history of unipolar depression
Description

unipolar depression

Type de données

boolean

Alias
UMLS CUI [1]
C0041696
patients who currently are being treated with antidepressants but continue to meet criteria for md (i.e., have not responded to the medications) and who are willing to discontinue the other medication and enter the study also will be included
Description

antidepressants

Type de données

boolean

Alias
UMLS CUI [1]
C0003289
currently residing in the community (own home,family member's home, or small group home) and agreeing to 13 weeks of followup in the study
Description

residence

Type de données

boolean

Alias
UMLS CUI [1]
C0237096
stable medical history and general health, in the opinion of the study psychiatrist
Description

medical history

Type de données

boolean

Alias
UMLS CUI [1]
C0262926
a caregiver who knows the patient well (spends at least 10 hours per week with him or her), and who is in reasonably good health, agrees to participate as well
Description

compliance behaviour

Type de données

boolean

Alias
UMLS CUI [1]
C1321605
participant and his/her legal representative provide informed consent
Description

informed consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
exclusion:
Description

Exclusion Criteria

Type de données

boolean

Alias
UMLS CUI [1]
C0680251
use of sertraline is contraindicated, based on the food and drug administration package insert for sertraline
Description

Medical contraindication sertraline

Type de données

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0074393
patient has a lifetime diagnosis of schizophrenia, bipolar disorder, or pre-ad anxiety disorder, as determined by the scid
Description

schizophrenia; bipolar disorder; anxiety disorder

Type de données

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0005586
UMLS CUI [3]
C0003469
patient has a current substance use disorder, as determined by the scid
Description

Substance Use Disorder

Type de données

boolean

Alias
UMLS CUI [1]
C0038586
patient is acutely suicidal or requires inpatient psychiatric hospitalization, as determined by the study psychiatrist
Description

suicidal; psychiatric hospitalization

Type de données

boolean

Alias
UMLS CUI [1]
C0438696
UMLS CUI [2]
C0748061
no psychotropic medicine dose changes, including cholinesterase inhibitors, after study entry
Description

Medication dose changed Psychotropic Drugs cholinesterase inhibitor

Type de données

boolean

Alias
UMLS CUI [1,1]
C1608430
UMLS CUI [1,2]
C0033978
UMLS CUI [1,3]
C0008425
may enter with any drug except another antidepressant.
Description

antidepressant

Type de données

boolean

Alias
UMLS CUI [1]
C0003289

Similar models

Eligibility Alzheimer Disease NCT00009191

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
alzheimers disease
Item
diagnosis of probable alzheimer's disease (ad) by nincds/adrda criteria (mckann et al., 1984), with a mmse score greater than 10
boolean
C0002395 (UMLS CUI [1])
major depressive episode
Item
diagnosis of current major depressive episode (md), by dsm-iv, based on the scid-iv examination
boolean
C0024517 (UMLS CUI [1])
unipolar depression
Item
patients will be included even if they have a pre-ad history of unipolar depression
boolean
C0041696 (UMLS CUI [1])
antidepressants
Item
patients who currently are being treated with antidepressants but continue to meet criteria for md (i.e., have not responded to the medications) and who are willing to discontinue the other medication and enter the study also will be included
boolean
C0003289 (UMLS CUI [1])
residence
Item
currently residing in the community (own home,family member's home, or small group home) and agreeing to 13 weeks of followup in the study
boolean
C0237096 (UMLS CUI [1])
medical history
Item
stable medical history and general health, in the opinion of the study psychiatrist
boolean
C0262926 (UMLS CUI [1])
compliance behaviour
Item
a caregiver who knows the patient well (spends at least 10 hours per week with him or her), and who is in reasonably good health, agrees to participate as well
boolean
C1321605 (UMLS CUI [1])
informed consent
Item
participant and his/her legal representative provide informed consent
boolean
C0021430 (UMLS CUI [1])
Exclusion Criteria
Item
exclusion:
boolean
C0680251 (UMLS CUI [1])
Medical contraindication sertraline
Item
use of sertraline is contraindicated, based on the food and drug administration package insert for sertraline
boolean
C1301624 (UMLS CUI [1,1])
C0074393 (UMLS CUI [1,2])
schizophrenia; bipolar disorder; anxiety disorder
Item
patient has a lifetime diagnosis of schizophrenia, bipolar disorder, or pre-ad anxiety disorder, as determined by the scid
boolean
C0036341 (UMLS CUI [1])
C0005586 (UMLS CUI [2])
C0003469 (UMLS CUI [3])
Substance Use Disorder
Item
patient has a current substance use disorder, as determined by the scid
boolean
C0038586 (UMLS CUI [1])
suicidal; psychiatric hospitalization
Item
patient is acutely suicidal or requires inpatient psychiatric hospitalization, as determined by the study psychiatrist
boolean
C0438696 (UMLS CUI [1])
C0748061 (UMLS CUI [2])
Medication dose changed Psychotropic Drugs cholinesterase inhibitor
Item
no psychotropic medicine dose changes, including cholinesterase inhibitors, after study entry
boolean
C1608430 (UMLS CUI [1,1])
C0033978 (UMLS CUI [1,2])
C0008425 (UMLS CUI [1,3])
antidepressant
Item
may enter with any drug except another antidepressant.
boolean
C0003289 (UMLS CUI [1])

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