ID

28912

Descripción

Safety and Efficacy Study in Patients With Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT00896363

Link

https://clinicaltrials.gov/show/NCT00896363

Palabras clave

Versiones (1)
  1. 15/2/18 15/2/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

15 de febrero de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Depressive Disorder NCT00896363

Inglés

Eligibility Depressive Disorder NCT00896363

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
currently have severe depression (major depressive disorder - without psychotic features)
Descripción

Severe depression | DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0588008
UMLS CUI [2]
C0743081
meet criteria (dsm iv-tr ) for current major depressive episode for at least 4 weeks but for no greater than 24 months
Descripción

Major depressive episode Duration

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0024517
UMLS CUI [1,2]
C0449238
depression questionnaire (hamd17) total score greater than or equal to 24
Descripción

Hamilton Depression Rating Scale 17 Item Questionnaire

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3639712
subject must read and able to give written informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
male or female 18 to 64 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
use appropriate birth control method
Descripción

Contraceptive methods Appropriate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C1548787
bmi 18.8 - 35.0 kg/m2 (inclusive)
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
primary diagnosis of other psychiatric disorders
Descripción

Principal diagnosis Mental disorders Other

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332137
UMLS CUI [1,2]
C0004936
UMLS CUI [1,3]
C0205394
thoughts of killing ones self or someone else
Descripción

Feeling suicidal | Homicidal thoughts

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0424000
UMLS CUI [2]
C0455204
taking psychiatric medicine or therapy within the six months
Descripción

Psychiatric drugs | Psychiatric therapeutic procedure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1979799
UMLS CUI [2]
C0204523
has previously failed an adequate course of medication for mdd from two different classes of antidepressants.
Descripción

Major Depressive Disorder | Pharmaceutical Preparations Course failed | Antidepressive Agents Class Different Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0750729
UMLS CUI [2,3]
C0231175
UMLS CUI [3,1]
C0003289
UMLS CUI [3,2]
C0456387
UMLS CUI [3,3]
C1705242
UMLS CUI [3,4]
C1265611
unstable medical disorder or a disorder that would interfere with the action of the drug
Descripción

Disease Unstable | Disease Interferes with Drug effect

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0728866
abuse of alcohol or drugs
Descripción

Substance Use Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
past history of serotonin syndrome or a history of clinical significant intolerance of ssris (class of drugs used for depression).
Descripción

Serotonin Syndrome | Intolerance to SSRIs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0699828
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0360105
history of migraine headaches that respond to treatment with triptan medication.
Descripción

Migraine Disorders Response Triptans

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C1704632
UMLS CUI [1,3]
C1567966
history of a clinically significant abnormality of the neurological system (including dementia and other cognitive disorders or significant head injury) or any history of seizure (excluding febrile seizure).
Descripción

Abnormal nervous system function | Dementia | Cognition Disorders | Craniocerebral Trauma | Seizure Except Febrile seizure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0234072
UMLS CUI [2]
C0497327
UMLS CUI [3]
C0009241
UMLS CUI [4]
C0018674
UMLS CUI [5,1]
C0036572
UMLS CUI [5,2]
C0332300
UMLS CUI [5,3]
C0009952
currently taking part in another clinical study or has done so within six months
Descripción

Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
pregnant, planning to become pregnant shortly or breastfeeding
Descripción

Pregnancy | Pregnancy, Planned | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0006147
history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy
Descripción

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Component | Drug Allergy | Hypersensitivity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C1705248
UMLS CUI [3]
C0013182
UMLS CUI [4]
C0020517
Volver a la parte superior de la página

Similar models

Eligibility Depressive Disorder NCT00896363

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Severe depression | DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE
Item
currently have severe depression (major depressive disorder - without psychotic features)
boolean
C0588008 (UMLS CUI [1])
C0743081 (UMLS CUI [2])
Major depressive episode Duration
Item
meet criteria (dsm iv-tr ) for current major depressive episode for at least 4 weeks but for no greater than 24 months
boolean
C0024517 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Hamilton Depression Rating Scale 17 Item Questionnaire
Item
depression questionnaire (hamd17) total score greater than or equal to 24
boolean
C3639712 (UMLS CUI [1])
Informed Consent
Item
subject must read and able to give written informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
male or female 18 to 64 years
boolean
C0001779 (UMLS CUI [1])
Contraceptive methods Appropriate
Item
use appropriate birth control method
boolean
C0700589 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
Body mass index
Item
bmi 18.8 - 35.0 kg/m2 (inclusive)
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Principal diagnosis Mental disorders Other
Item
primary diagnosis of other psychiatric disorders
boolean
C0332137 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Feeling suicidal | Homicidal thoughts
Item
thoughts of killing ones self or someone else
boolean
C0424000 (UMLS CUI [1])
C0455204 (UMLS CUI [2])
Psychiatric drugs | Psychiatric therapeutic procedure
Item
taking psychiatric medicine or therapy within the six months
boolean
C1979799 (UMLS CUI [1])
C0204523 (UMLS CUI [2])
Major Depressive Disorder | Pharmaceutical Preparations Course failed | Antidepressive Agents Class Different Quantity
Item
has previously failed an adequate course of medication for mdd from two different classes of antidepressants.
boolean
C1269683 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0750729 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C0003289 (UMLS CUI [3,1])
C0456387 (UMLS CUI [3,2])
C1705242 (UMLS CUI [3,3])
C1265611 (UMLS CUI [3,4])
Disease Unstable | Disease Interferes with Drug effect
Item
unstable medical disorder or a disorder that would interfere with the action of the drug
boolean
C0012634 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0728866 (UMLS CUI [2,3])
Substance Use Disorders
Item
abuse of alcohol or drugs
boolean
C0038586 (UMLS CUI [1])
Serotonin Syndrome | Intolerance to SSRIs
Item
past history of serotonin syndrome or a history of clinical significant intolerance of ssris (class of drugs used for depression).
boolean
C0699828 (UMLS CUI [1])
C1744706 (UMLS CUI [2,1])
C0360105 (UMLS CUI [2,2])
Migraine Disorders Response Triptans
Item
history of migraine headaches that respond to treatment with triptan medication.
boolean
C0149931 (UMLS CUI [1,1])
C1704632 (UMLS CUI [1,2])
C1567966 (UMLS CUI [1,3])
Abnormal nervous system function | Dementia | Cognition Disorders | Craniocerebral Trauma | Seizure Except Febrile seizure
Item
history of a clinically significant abnormality of the neurological system (including dementia and other cognitive disorders or significant head injury) or any history of seizure (excluding febrile seizure).
boolean
C0234072 (UMLS CUI [1])
C0497327 (UMLS CUI [2])
C0009241 (UMLS CUI [3])
C0018674 (UMLS CUI [4])
C0036572 (UMLS CUI [5,1])
C0332300 (UMLS CUI [5,2])
C0009952 (UMLS CUI [5,3])
Study Subject Participation Status
Item
currently taking part in another clinical study or has done so within six months
boolean
C2348568 (UMLS CUI [1])
Pregnancy | Pregnancy, Planned | Breast Feeding
Item
pregnant, planning to become pregnant shortly or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Component | Drug Allergy | Hypersensitivity
Item
history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
C0013182 (UMLS CUI [3])
C0020517 (UMLS CUI [4])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial