ID

14099

Description

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

Keywords

  1. 3/29/16 3/29/16 -
Uploaded on

March 29, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Depression NCT00177528

Eligibility Depression NCT00177528

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

Inclusion Criteria

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

Gender, ethnic groups and age

Data type

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;
Description

DSM-IV diagnosis of major depressive episode

Data type

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;
Description

Hamilton Rating Scale for Depression

Data type

boolean

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

Mini-mental state examination

Data type

boolean

Alias
UMLS CUI [1]
C0451306
Exclusion Criteria
Description

Exclusion Criteria

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

Mental status

Data type

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;
Description

Substance abuse disorder

Data type

boolean

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

Serum sodium measurement

Data type

boolean

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

Hypertension

Data type

boolean

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

Venlafaxine allergy

Data type

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;
Description

Venlafaxine therapy and ECG

Data type

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;
Description

Cardiovascular status

Data type

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.
Description

Suicide risk

Data type

boolean

Alias
UMLS CUI [1]
C1271074

Similar models

Eligibility Depression NCT00177528

  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00177528
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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