ID

21768

Descripción

An Open Trial of Duloxetine on Comorbid Major Depression and Chronic Headache; ODM derived from: https://clinicaltrials.gov/show/NCT00531895

Link

https://clinicaltrials.gov/show/NCT00531895

Palabras clave

Versiones (1)
  1. 29/4/17 29/4/17 -
Subido en

29 de abril de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Major Depression NCT00531895

Inglés

Eligibility Major Depression NCT00531895

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
major depression (according to dsm-iv criteria)
Descripción

Major Depressive Disorder

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1269683
madrs scores superior to 21
Descripción

Montgomery-Asberg Depression Rating Scale Questionnaire

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4054475
subjects meeting the international headache society criteria for chronic primary headache (ihsc-2 codes 1.5.1, 1.6.1, 2.3.1, 2.3.2 and 2.4.3) (ichs, 2003)
Descripción

Primary Headache Disorder chronic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1565106
UMLS CUI [1,2]
C0205191
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
over 50% reduction on madrs scores during wash-out period
Descripción

Montgomery-Asberg Depression Rating Scale Questionnaire Reduction Percentage Washout Period

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4054475
UMLS CUI [1,2]
C0392756
UMLS CUI [1,3]
C0439165
UMLS CUI [1,4]
C1710661
illicit drug or alcohol dependence
Descripción

Illicit Drugs Dependence | Alcoholic Intoxication, Chronic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0086190
UMLS CUI [1,2]
C0439857
UMLS CUI [2]
C0001973
history of multiple allergies or hypersensitivity to duloxetine
Descripción

Multiple allergies | Hypersensitivity duloxetine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0740281
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0245561
history of epilepsy or significant neurological disorder
Descripción

Epilepsy | nervous system disorder

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2]
C0027765
significant suicide risk
Descripción

At risk for suicide

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0563664
pregnancy or lactation
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
sexually active female subjects not using an efficient contraceptive method
Descripción

Gender Sexually active | Contraceptive methods Lacking

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0241028
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0332268
significant laboratory abnormalities at baseline
Descripción

LABORATORY ABNORMALITIES

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1853129
significant clinical disease
Descripción

Disease Clinical Significance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826293
subjects meeting dsm-iv criteria for somatisation disorder. (300.81) or presenting with delusional pain symptoms.
Descripción

Somatization Disorder | Delusional pain Symptoms

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0520482
UMLS CUI [2,1]
C0394998
UMLS CUI [2,2]
C1457887
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Similar models

Eligibility Major Depression NCT00531895

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder
Item
major depression (according to dsm-iv criteria)
boolean
C1269683 (UMLS CUI [1])
Montgomery-Asberg Depression Rating Scale Questionnaire
Item
madrs scores superior to 21
boolean
C4054475 (UMLS CUI [1])
Primary Headache Disorder chronic
Item
subjects meeting the international headache society criteria for chronic primary headache (ihsc-2 codes 1.5.1, 1.6.1, 2.3.1, 2.3.2 and 2.4.3) (ichs, 2003)
boolean
C1565106 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Montgomery-Asberg Depression Rating Scale Questionnaire Reduction Percentage Washout Period
Item
over 50% reduction on madrs scores during wash-out period
boolean
C4054475 (UMLS CUI [1,1])
C0392756 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C1710661 (UMLS CUI [1,4])
Illicit Drugs Dependence | Alcoholic Intoxication, Chronic
Item
illicit drug or alcohol dependence
boolean
C0086190 (UMLS CUI [1,1])
C0439857 (UMLS CUI [1,2])
C0001973 (UMLS CUI [2])
Multiple allergies | Hypersensitivity duloxetine
Item
history of multiple allergies or hypersensitivity to duloxetine
boolean
C0740281 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0245561 (UMLS CUI [2,2])
Epilepsy | nervous system disorder
Item
history of epilepsy or significant neurological disorder
boolean
C0014544 (UMLS CUI [1])
C0027765 (UMLS CUI [2])
At risk for suicide
Item
significant suicide risk
boolean
C0563664 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Gender Sexually active | Contraceptive methods Lacking
Item
sexually active female subjects not using an efficient contraceptive method
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
LABORATORY ABNORMALITIES
Item
significant laboratory abnormalities at baseline
boolean
C1853129 (UMLS CUI [1])
Disease Clinical Significance
Item
significant clinical disease
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Somatization Disorder | Delusional pain Symptoms
Item
subjects meeting dsm-iv criteria for somatisation disorder. (300.81) or presenting with delusional pain symptoms.
boolean
C0520482 (UMLS CUI [1])
C0394998 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
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