ID

28825

Descrição

Venlafaxine Augmentation in Treatment Resistant Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00253266

Link

https://clinicaltrials.gov/show/NCT00253266

Palavras-chave

Versões (1)
  1. 06/02/2018 06/02/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

6 de fevereiro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Depression NCT00253266

Inglês

Eligibility Depression NCT00253266

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00253266
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
female and male inpatients with a major depressive disorder without psychotic features or with a depressive episode within a bipolar i or ii disorder without psychotic features
Descrição

DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE | Depressive episode | Bipolar I disorder Without Psychotic symptom | Bipolar II disorder Without Psychotic symptom

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0743081
UMLS CUI [2]
C0349217
UMLS CUI [3,1]
C0853193
UMLS CUI [3,2]
C0332288
UMLS CUI [3,3]
C0871189
UMLS CUI [4,1]
C0236788
UMLS CUI [4,2]
C0332288
UMLS CUI [4,3]
C0871189
ages between 20 and 70 years
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
total score greater than 18 on the hamilton depression rating scale
Descrição

Hamilton rating scale for depression

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0451203
documentation of at least one ineffective antidepressant drug trial under adequate dosage for at least 6 weeks in the current episode
Descrição

Antidepressive Agents Dosage Adequate | Attempt Quantity ineffective

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205411
UMLS CUI [2,1]
C1516084
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C3242229
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
other psychiatric axis i disorders than those mentioned as inclusion criteria
Descrição

Axis I diagnosis Other

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0270287
UMLS CUI [1,2]
C0205394
acute suicidality (item 3 of the hamilton depression rating scale greater than 2)
Descrição

Suicidality Hamilton rating scale for depression

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3166387
UMLS CUI [1,2]
C0451203
drug or alcohol addiction
Descrição

Substance Dependence

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038580
patients with severe hepatic, cardiovascular, neurologic, metabolic or malignant disorders
Descrição

Liver diseases Severe | Cardiovascular Diseases Severe | Nervous system disorder Severe | Metabolic Diseases Severe | Malignant disease Severe

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0027765
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0025517
UMLS CUI [4,2]
C0205082
UMLS CUI [5,1]
C0442867
UMLS CUI [5,2]
C0205082
documentation or report of a previous ineffective treatment trial with venlafaxine, lamotrigine or quetiapine
Descrição

Venlafaxine ineffective | Lamotrigine ineffective | Quetiapine ineffective

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0078569
UMLS CUI [1,2]
C3242229
UMLS CUI [2,1]
C0064636
UMLS CUI [2,2]
C3242229
UMLS CUI [3,1]
C0123091
UMLS CUI [3,2]
C3242229
functional kidney disorders
Descrição

Functional kidney disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1408246
untreated hypertension
Descrição

Hypertension untreated

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0745134
acute treatment with thyroid hormone (less than 3 months)
Descrição

Thyroid Hormones

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0040135
pregnant or nursing patients
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women of childbearing age without effective contraception
Descrição

Childbearing Potential Contraceptive methods Lacking

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332268
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Similar models

Eligibility Depression NCT00253266

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00253266
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE | Depressive episode | Bipolar I disorder Without Psychotic symptom | Bipolar II disorder Without Psychotic symptom
Item
female and male inpatients with a major depressive disorder without psychotic features or with a depressive episode within a bipolar i or ii disorder without psychotic features
boolean
C0743081 (UMLS CUI [1])
C0349217 (UMLS CUI [2])
C0853193 (UMLS CUI [3,1])
C0332288 (UMLS CUI [3,2])
C0871189 (UMLS CUI [3,3])
C0236788 (UMLS CUI [4,1])
C0332288 (UMLS CUI [4,2])
C0871189 (UMLS CUI [4,3])
Age
Item
ages between 20 and 70 years
boolean
C0001779 (UMLS CUI [1])
Hamilton rating scale for depression
Item
total score greater than 18 on the hamilton depression rating scale
boolean
C0451203 (UMLS CUI [1])
Antidepressive Agents Dosage Adequate | Attempt Quantity ineffective
Item
documentation of at least one ineffective antidepressant drug trial under adequate dosage for at least 6 weeks in the current episode
boolean
C0003289 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205411 (UMLS CUI [1,3])
C1516084 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C3242229 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Axis I diagnosis Other
Item
other psychiatric axis i disorders than those mentioned as inclusion criteria
boolean
C0270287 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Suicidality Hamilton rating scale for depression
Item
acute suicidality (item 3 of the hamilton depression rating scale greater than 2)
boolean
C3166387 (UMLS CUI [1,1])
C0451203 (UMLS CUI [1,2])
Substance Dependence
Item
drug or alcohol addiction
boolean
C0038580 (UMLS CUI [1])
Liver diseases Severe | Cardiovascular Diseases Severe | Nervous system disorder Severe | Metabolic Diseases Severe | Malignant disease Severe
Item
patients with severe hepatic, cardiovascular, neurologic, metabolic or malignant disorders
boolean
C0023895 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0027765 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0025517 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0442867 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
Venlafaxine ineffective | Lamotrigine ineffective | Quetiapine ineffective
Item
documentation or report of a previous ineffective treatment trial with venlafaxine, lamotrigine or quetiapine
boolean
C0078569 (UMLS CUI [1,1])
C3242229 (UMLS CUI [1,2])
C0064636 (UMLS CUI [2,1])
C3242229 (UMLS CUI [2,2])
C0123091 (UMLS CUI [3,1])
C3242229 (UMLS CUI [3,2])
Functional kidney disease
Item
functional kidney disorders
boolean
C1408246 (UMLS CUI [1])
Hypertension untreated
Item
untreated hypertension
boolean
C0745134 (UMLS CUI [1])
Thyroid Hormones
Item
acute treatment with thyroid hormone (less than 3 months)
boolean
C0040135 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or nursing patients
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Lacking
Item
women of childbearing age without effective contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
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