ID

28912

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00896363

Nyckelord

Versioner (1)
  1. 2018-02-15 2018-02-15 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

15 februari 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Depressive Disorder NCT00896363

Engelsk

Eligibility Depressive Disorder NCT00896363

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Severe depression | DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE

Datatyp

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
Beskrivning

Major depressive episode Duration

Datatyp

boolean

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

Hamilton Depression Rating Scale 17 Item Questionnaire

Datatyp

boolean

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

Informed Consent

Datatyp

boolean

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

Age

Datatyp

boolean

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

Contraceptive methods Appropriate

Datatyp

boolean

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

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
primary diagnosis of other psychiatric disorders
Beskrivning

Principal diagnosis Mental disorders Other

Datatyp

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
Beskrivning

Feeling suicidal | Homicidal thoughts

Datatyp

boolean

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

Psychiatric drugs | Psychiatric therapeutic procedure

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

Disease Unstable | Disease Interferes with Drug effect

Datatyp

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
Beskrivning

Substance Use Disorders

Datatyp

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).
Beskrivning

Serotonin Syndrome | Intolerance to SSRIs

Datatyp

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.
Beskrivning

Migraine Disorders Response Triptans

Datatyp

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).
Beskrivning

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

Datatyp

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
Beskrivning

Study Subject Participation Status

Datatyp

boolean

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

Pregnancy | Pregnancy, Planned | Breast Feeding

Datatyp

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
Beskrivning

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

Datatyp

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
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Similar models

Eligibility Depressive Disorder NCT00896363

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
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