ID

14099

Descrição

Safety and Efficacy of Venlafaxine XR in Elderly Patients With Major Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00177528

Link

https://clinicaltrials.gov/show/NCT00177528

Palavras-chave

  1. 29/03/2016 29/03/2016 -
Transferido a

29 de março de 2016

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Depression NCT00177528

Eligibility Depression NCT00177528

  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00177528
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women of all races who are 60 years old or older;
Descrição

Gender, ethnic groups and age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0015031
UMLS CUI [3]
C0001779
a dsm-iv diagnosis of major depressive episode without psychotic features;
Descrição

DSM-IV diagnosis of major depressive episode

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2199206
17-item ham-d score of >15 for potential subjects who have not received any antidepressant treatment during this illness episode or ham-d > 11 for potential subjects who have received treatment with an antidepressant (other than venlafaxine-xr) during this illness episode;
Descrição

Hamilton Rating Scale for Depression

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0451203
a mmse score of >15.
Descrição

Mini-mental state examination

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0451306
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of meeting dsm-iv criteria for mania, schizophrenia or other psychotic disorder;
Descrição

Mental status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0024713
UMLS CUI [2]
C0036341
UMLS CUI [3]
C0033975
history of substance abuse or dependence, including alcohol, within the last three months;
Descrição

Substance abuse disorder

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038586
current hyponatremia (as defined as a serum sodium level < 130 meq/l);
Descrição

Serum sodium measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0523891
untreated or uncontrolled hypertension;
Descrição

Hypertension

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0020538
a history of being unable to tolerate venlafaxine-xr or venlafaxine immediate release formulation;
Descrição

Venlafaxine allergy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0570764
history of receiving venlafaxine-xr or venlafaxine immediate release formulation of 6 or more weeks at 300mg/d during index depressive episode; (7) ekg revealing qtc > 480 msec;
Descrição

Venlafaxine therapy and ECG

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0078569
UMLS CUI [2]
C0489625
myocardial infarction, unstable angina, palpitation or cardiogenic syncope within 3 months prior to entering this study;
Descrição

Cardiovascular status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0030252
UMLS CUI [4]
C0751535
the presence of active suicidal ideation with intent.
Descrição

Suicide risk

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1271074

Similar models

Eligibility Depression NCT00177528

  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00177528
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Gender, ethnic groups and age
Item
men and women of all races who are 60 years old or older;
boolean
C0079399 (UMLS CUI [1])
C0015031 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
DSM-IV diagnosis of major depressive episode
Item
a dsm-iv diagnosis of major depressive episode without psychotic features;
boolean
C2199206 (UMLS CUI [1])
Hamilton Rating Scale for Depression
Item
17-item ham-d score of >15 for potential subjects who have not received any antidepressant treatment during this illness episode or ham-d > 11 for potential subjects who have received treatment with an antidepressant (other than venlafaxine-xr) during this illness episode;
boolean
C0451203 (UMLS CUI [1])
Mini-mental state examination
Item
a mmse score of >15.
boolean
C0451306 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Mental status
Item
history of meeting dsm-iv criteria for mania, schizophrenia or other psychotic disorder;
boolean
C0024713 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
C0033975 (UMLS CUI [3])
Substance abuse disorder
Item
history of substance abuse or dependence, including alcohol, within the last three months;
boolean
C0038586 (UMLS CUI [1])
Serum sodium measurement
Item
current hyponatremia (as defined as a serum sodium level < 130 meq/l);
boolean
C0523891 (UMLS CUI [1])
Hypertension
Item
untreated or uncontrolled hypertension;
boolean
C0020538 (UMLS CUI [1])
Venlafaxine allergy
Item
a history of being unable to tolerate venlafaxine-xr or venlafaxine immediate release formulation;
boolean
C0570764 (UMLS CUI [1])
Venlafaxine therapy and ECG
Item
history of receiving venlafaxine-xr or venlafaxine immediate release formulation of 6 or more weeks at 300mg/d during index depressive episode; (7) ekg revealing qtc > 480 msec;
boolean
C0078569 (UMLS CUI [1])
C0489625 (UMLS CUI [2])
Cardiovascular status
Item
myocardial infarction, unstable angina, palpitation or cardiogenic syncope within 3 months prior to entering this study;
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0030252 (UMLS CUI [3])
C0751535 (UMLS CUI [4])
Suicide risk
Item
the presence of active suicidal ideation with intent.
boolean
C1271074 (UMLS CUI [1])

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