ID

24582

Descripción

Study Comparing the Efficacy of Venlafaxine XR Vs. SSRIs and Conventional Antidepressants in Depressed Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00474708

Link

https://clinicaltrials.gov/show/NCT00474708

Palabras clave

Versiones (1)
  1. 7/8/17 7/8/17 -
Subido en

7 de agosto de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00474708

Inglés

Eligibility Major Depressive Disorder NCT00474708

1 formularios  
Criteria
Descripción

Criteria

males or females, 18 -65 years of age
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
outpatients
Descripción

Outpatients

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0029921
major depressive disorder based on dsm-iv criteria
Descripción

Major Depressive Disorder

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1269683
the baseline score of 17-item ham-d³17
Descripción

Hamilton Depression Rating Scale 17 Item Questionnaire

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3639712
switchers from prior antidepressants, who have had no satisfactory improvement (normally after a minimum of 8weeks of treatment), with an approved antidepressant medication or have experienced intolerance due to side effects to their antidepressant medication based on clinical discretion
Descripción

Change of medication | Antidepressive Agents Unsatisfactory | Intolerance to Antidepressive Agents | Adverse reaction to Antidepressive Agents

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0580105
UMLS CUI [2,1]
C0003289
UMLS CUI [2,2]
C0439856
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0003289
UMLS CUI [4,1]
C0041755
UMLS CUI [4,2]
C0003289
provide written informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
if female is of childbearing potential, must be confirmed no pregnancy at baseline, and use a medically acceptable method of contraception throughout the study.
Descripción

Childbearing Potential Pregnancy test negative Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [1,3]
C0700589
main exclusion criteria:
Descripción

Exclusion Criteria Main

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
hypersensitivity to venlafaxine;
Descripción

Venlafaxine allergy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0570764
clinically significant renal or hepatic disease or any other medical disease that, in the opinion of the investigator, might compromise the study, including seizure
Descripción

Kidney Disease | Liver disease | Disease compromises Clinical Trial | Seizures

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0023895
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C0008976
UMLS CUI [4]
C0036572
alcohol or drug abuse within the last year
Descripción

Substance Use Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
a recent history of myocardial infarction or unstable heart disease (within 6 months of baseline)
Descripción

Myocardial Infarction | Heart Disease Unstable

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0443343
bipolar disorder
Descripción

Bipolar Disorder

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005586
for female, known or suspected pregnancy or breast feeding
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
use of a monoamine oxidase inhibitor (maoi) within 14 days of baseline; use of any investigational drug within 30 days of baseline.
Descripción

Monoamine Oxidase Inhibitors | Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0026457
UMLS CUI [2]
C0013230
patients have prior use of venlafaxine or use of venlafaxine for the current episode.
Descripción

venlafaxine | Single major depressive episode

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0078569
UMLS CUI [2]
C0024517
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Similar models

Eligibility Major Depressive Disorder NCT00474708

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Age
Item
males or females, 18 -65 years of age
boolean
C0001779 (UMLS CUI [1])
Outpatients
Item
outpatients
boolean
C0029921 (UMLS CUI [1])
Major Depressive Disorder
Item
major depressive disorder based on dsm-iv criteria
boolean
C1269683 (UMLS CUI [1])
Hamilton Depression Rating Scale 17 Item Questionnaire
Item
the baseline score of 17-item ham-d³17
boolean
C3639712 (UMLS CUI [1])
Change of medication | Antidepressive Agents Unsatisfactory | Intolerance to Antidepressive Agents | Adverse reaction to Antidepressive Agents
Item
switchers from prior antidepressants, who have had no satisfactory improvement (normally after a minimum of 8weeks of treatment), with an approved antidepressant medication or have experienced intolerance due to side effects to their antidepressant medication based on clinical discretion
boolean
C0580105 (UMLS CUI [1])
C0003289 (UMLS CUI [2,1])
C0439856 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C0003289 (UMLS CUI [3,2])
C0041755 (UMLS CUI [4,1])
C0003289 (UMLS CUI [4,2])
Informed Consent
Item
provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative Contraceptive methods
Item
if female is of childbearing potential, must be confirmed no pregnancy at baseline, and use a medically acceptable method of contraception throughout the study.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Exclusion Criteria Main
Item
main exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Venlafaxine allergy
Item
hypersensitivity to venlafaxine;
boolean
C0570764 (UMLS CUI [1])
Kidney Disease | Liver disease | Disease compromises Clinical Trial | Seizures
Item
clinically significant renal or hepatic disease or any other medical disease that, in the opinion of the investigator, might compromise the study, including seizure
boolean
C0022658 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0012634 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C0008976 (UMLS CUI [3,3])
C0036572 (UMLS CUI [4])
Substance Use Disorders
Item
alcohol or drug abuse within the last year
boolean
C0038586 (UMLS CUI [1])
Myocardial Infarction | Heart Disease Unstable
Item
a recent history of myocardial infarction or unstable heart disease (within 6 months of baseline)
boolean
C0027051 (UMLS CUI [1])
C0018799 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
Bipolar Disorder
Item
bipolar disorder
boolean
C0005586 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
for female, known or suspected pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Monoamine Oxidase Inhibitors | Investigational New Drugs
Item
use of a monoamine oxidase inhibitor (maoi) within 14 days of baseline; use of any investigational drug within 30 days of baseline.
boolean
C0026457 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
venlafaxine | Single major depressive episode
Item
patients have prior use of venlafaxine or use of venlafaxine for the current episode.
boolean
C0078569 (UMLS CUI [1])
C0024517 (UMLS CUI [2])
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