ID

28864

Descrição

A Study Comparing Duloxetine to Other Antidepressants in the Treatment of Severe Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00666757

Link

https://clinicaltrials.gov/show/NCT00666757

Palavras-chave

Versões (1)
  1. 08/02/2018 08/02/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

8 de fevereiro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Depression NCT00666757

Inglês

Eligibility Depression NCT00666757

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00666757
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
at least 18 years of age
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
have major depression and are currently in a severe depressive episode
Descrição

Major Depressive Disorder | Depressive episode Severe

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2,1]
C0349217
UMLS CUI [2,2]
C0205082
have a degree of understanding such that patient can communicate with the investigator and study staff
Descrição

Able to communicate Research Personnel

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2364293
UMLS CUI [1,2]
C0035173
all females must test negative for pregnancy
Descrição

Gender Pregnancy test negative

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0427780
females of childbearing potential must use reliable method of birth control during the study and for 1 month after taking the last dose of study drug
Descrição

Childbearing Potential Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
have not responded to duloxetine for depression in the past
Descrição

Duloxetine | Depressive disorder Unresponsive to Treatment

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0245561
UMLS CUI [2,1]
C0011581
UMLS CUI [2,2]
C0205269
have a history of bipolar disorder, a psychotic disorder (such as schizophrenia), a cognitive disorder (such as moderate or severe dementia), or obsessive-compulsive disorder (ocd)
Descrição

Bipolar Disorder | Psychotic Disorders | Schizophrenia | Cognition Disorders | Moderate dementia | Severe dementia | Obsessive-Compulsive Disorder

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005586
UMLS CUI [2]
C0033975
UMLS CUI [3]
C0036341
UMLS CUI [4]
C0009241
UMLS CUI [5]
C3494871
UMLS CUI [6]
C3494652
UMLS CUI [7]
C0028768
are at significant risk for suicide
Descrição

At risk for suicide

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0563664
have not responded to 2 or more adequate trials of antidepressant medications during the current depressive episode
Descrição

Antidepressive Agents | Therapeutic procedure Quantity failed | Depressive episode

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0003289
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0231175
UMLS CUI [3]
C0349217
have a serious, unstable medical condition
Descrição

Medical condition Unstable Serious

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C0205404
have a current or recent history of substance abuse or dependence
Descrição

Substance Use Disorders | Substance Dependence

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
have had electroconvulsive therapy (ect), transcranial magnetic stimulation (rtms), or vagus nerve stimulation (vns) in the past year
Descrição

Electroconvulsive Therapy | Transcranial magnetic stimulation | Vagus Nerve Stimulation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013806
UMLS CUI [2]
C0436548
UMLS CUI [3]
C2350432
have started psychotherapy within 6 weeks prior to study entry
Descrição

Psychotherapy Started

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0033968
UMLS CUI [1,2]
C1272689
have a serious medical illness or clinically significant laboratory abnormality that is not stabilized or is anticipated, in the judgment of the investigator, to require hospitalization or use of an excluded medication during the course of the study
Descrição

Illness Serious | Laboratory test result abnormal | Hospitalization Required | Patient need for Pharmaceutical Preparations Excluded

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0438215
UMLS CUI [3]
C1708385
UMLS CUI [4,1]
C0686904
UMLS CUI [4,2]
C0013227
UMLS CUI [4,3]
C0332196
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Similar models

Eligibility Depression NCT00666757

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00666757
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
Major Depressive Disorder | Depressive episode Severe
Item
have major depression and are currently in a severe depressive episode
boolean
C1269683 (UMLS CUI [1])
C0349217 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Able to communicate Research Personnel
Item
have a degree of understanding such that patient can communicate with the investigator and study staff
boolean
C2364293 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
Gender Pregnancy test negative
Item
all females must test negative for pregnancy
boolean
C0079399 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods
Item
females of childbearing potential must use reliable method of birth control during the study and for 1 month after taking the last dose of study drug
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Duloxetine | Depressive disorder Unresponsive to Treatment
Item
have not responded to duloxetine for depression in the past
boolean
C0245561 (UMLS CUI [1])
C0011581 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
Bipolar Disorder | Psychotic Disorders | Schizophrenia | Cognition Disorders | Moderate dementia | Severe dementia | Obsessive-Compulsive Disorder
Item
have a history of bipolar disorder, a psychotic disorder (such as schizophrenia), a cognitive disorder (such as moderate or severe dementia), or obsessive-compulsive disorder (ocd)
boolean
C0005586 (UMLS CUI [1])
C0033975 (UMLS CUI [2])
C0036341 (UMLS CUI [3])
C0009241 (UMLS CUI [4])
C3494871 (UMLS CUI [5])
C3494652 (UMLS CUI [6])
C0028768 (UMLS CUI [7])
At risk for suicide
Item
are at significant risk for suicide
boolean
C0563664 (UMLS CUI [1])
Antidepressive Agents | Therapeutic procedure Quantity failed | Depressive episode
Item
have not responded to 2 or more adequate trials of antidepressant medications during the current depressive episode
boolean
C0003289 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C0349217 (UMLS CUI [3])
Medical condition Unstable Serious
Item
have a serious, unstable medical condition
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
Substance Use Disorders | Substance Dependence
Item
have a current or recent history of substance abuse or dependence
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Electroconvulsive Therapy | Transcranial magnetic stimulation | Vagus Nerve Stimulation
Item
have had electroconvulsive therapy (ect), transcranial magnetic stimulation (rtms), or vagus nerve stimulation (vns) in the past year
boolean
C0013806 (UMLS CUI [1])
C0436548 (UMLS CUI [2])
C2350432 (UMLS CUI [3])
Psychotherapy Started
Item
have started psychotherapy within 6 weeks prior to study entry
boolean
C0033968 (UMLS CUI [1,1])
C1272689 (UMLS CUI [1,2])
Illness Serious | Laboratory test result abnormal | Hospitalization Required | Patient need for Pharmaceutical Preparations Excluded
Item
have a serious medical illness or clinically significant laboratory abnormality that is not stabilized or is anticipated, in the judgment of the investigator, to require hospitalization or use of an excluded medication during the course of the study
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0438215 (UMLS CUI [2])
C1708385 (UMLS CUI [3])
C0686904 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C0332196 (UMLS CUI [4,3])
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