ID

28902

Description

SubGenual CG25 Deep Brain Stimulation in Severe Resistant Depression; ODM derived from: https://clinicaltrials.gov/show/NCT01834560

Lien

https://clinicaltrials.gov/show/NCT01834560

Mots-clés

Versions (1)
  1. 14/02/2018 14/02/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

14 février 2018

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Depression NCT01834560

Anglais

Eligibility Depression NCT01834560

1 Formulaires  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT01834560
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women between 30 and 55 years old
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
women at a reproductive age will have to be under successful contraceptive and will undergo a pregnancy test before inclusion
Description

Childbearing Potential Contraceptive methods | Childbearing Potential Pregnancy Test

Type de données

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0032976
patient suffering from major unipolar depression refractory to conventional therapies
Description

Major Depressive Disorder Unipolar | Conventional Treatment refractory

Type de données

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0443340
UMLS CUI [2,1]
C2945704
UMLS CUI [2,2]
C0205269
chronic depression with ongoing depressive episode > 12 months.
Description

Chronic depression | Depressive episode Duration

Type de données

boolean

Alias
UMLS CUI [1]
C0581391
UMLS CUI [2,1]
C0349217
UMLS CUI [2,2]
C0449238
4 unsuccessful therapies attempted to treat the ongoing episode, including anti-depressant monotherapies, potentialisation of antidepressant treatments, validated structured psychotherapies, electro-convulsive therapy performed accordingly to anaes ( agence nationale d'accréditation et d'evaluation en santé-the french health authority) recommendations (at least 6 sessions with bilateral technique and length control of convulsive crisis).
Description

Depressive episode Unresponsive to Treatment | Antidepressive Agents | Antidepressive Agents Potentiation | Psychotherapy | Electroconvulsive Therapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0349217
UMLS CUI [1,2]
C0205269
UMLS CUI [2]
C0003289
UMLS CUI [3,1]
C0003289
UMLS CUI [3,2]
C0086188
UMLS CUI [4]
C0033968
UMLS CUI [5]
C0013806
ambulatory or hospital care
Description

Ambulatory care | Hospital care

Type de données

boolean

Alias
UMLS CUI [1]
C0002423
UMLS CUI [2]
C0259945
able to speak french, understand study procedures and complete questionnaires.
Description

Able to speak French language | Comprehension Clinical Trial Procedure | Questionnaires Completion

Type de données

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376246
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C0184661
UMLS CUI [3,1]
C0034394
UMLS CUI [3,2]
C0205197
covered by french social health system
Description

Coverage Health Insurance social France

Type de données

boolean

Alias
UMLS CUI [1,1]
C1551362
UMLS CUI [1,2]
C0021682
UMLS CUI [1,3]
C0728831
UMLS CUI [1,4]
C0016674
living in rhone-alpes area without plan to move in the next 2 years
Description

Residence | Relocation of home Plan Absent

Type de données

boolean

Alias
UMLS CUI [1]
C0237096
UMLS CUI [2,1]
C2699029
UMLS CUI [2,2]
C1301732
UMLS CUI [2,3]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of cerebral surgery
Description

Operation on brain

Type de données

boolean

Alias
UMLS CUI [1]
C0195775
neurological disorder that can interfere with evaluation of surgical procedure or significant cognitive impairment (mattis score < 30)
Description

Nervous system disorder Interferes with Evaluation Operative Surgical Procedures | Impaired cognition Clinical dementia rating scale

Type de données

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1261322
UMLS CUI [1,4]
C0543467
UMLS CUI [2,1]
C0338656
UMLS CUI [2,2]
C0451074
psychiatric disorder responsible for comorbidity with the major depressive episode (schizophrenia and other delirium, diagnosed anxiety except generalized anxiety disorder, substance dependency)
Description

Mental disorder Resulting in Comorbidity Major depressive episode | Schizophrenia | Delirium | Anxiety Except Generalized Anxiety Disorder | Substance Dependence

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C0009488
UMLS CUI [1,4]
C0024517
UMLS CUI [2]
C0036341
UMLS CUI [3]
C0011206
UMLS CUI [4,1]
C0003467
UMLS CUI [4,2]
C0332300
UMLS CUI [4,3]
C0270549
UMLS CUI [5]
C0038580
personality disorder of a and b clusters
Description

Cluster A personality disorder | Cluster B personality disorder

Type de données

boolean

Alias
UMLS CUI [1]
C0009084
UMLS CUI [2]
C0009086
suicidal ideas at evaluation, intention for auto-destruction, repeated suicidal attempts in the last 3 years with emergency care or hospitalization
Description

Feeling suicidal | Intention Self-harm | Suicide attempt Repeated | Emergency Care | Hospitalization

Type de données

boolean

Alias
UMLS CUI [1]
C0424000
UMLS CUI [2,1]
C0162425
UMLS CUI [2,2]
C0424366
UMLS CUI [3,1]
C0038663
UMLS CUI [3,2]
C0205341
UMLS CUI [4]
C1527398
UMLS CUI [5]
C0019993
severe somatic pathology or contraindication to surgery due to heart defibrillator/pacemaker or other implanted device.
Description

Disease Somatic Severe | Medical contraindication Operative Surgical Procedures Due to Defibrillators | Medical contraindication Operative Surgical Procedures Due to Artificial cardiac pacemaker | Medical contraindication Operative Surgical Procedures Due to Implants

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2986476
UMLS CUI [1,3]
C0205082
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0543467
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0180307
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0543467
UMLS CUI [3,3]
C0678226
UMLS CUI [3,4]
C0030163
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0543467
UMLS CUI [4,3]
C0678226
UMLS CUI [4,4]
C0021102
a decrease superior to or equal to 20% in the 17-hamilton depression rating scale score between inclusion and pre-surgery evaluation
Description

Hamilton Depression Rating Scale 17 Item Questionnaire Decrease Percentage

Type de données

boolean

Alias
UMLS CUI [1,1]
C3639712
UMLS CUI [1,2]
C0547047
UMLS CUI [1,3]
C0439165
drug dependency including alcohol in the last 12 months with history of abuse in the last 6 months, with the exception of nicotine
Description

Substance Dependence | Substance Use Disorders | Exception Nicotine

Type de données

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2]
C0038586
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0028040
persons protected by the law.
Description

Persons Aspects of laws

Type de données

boolean

Alias
UMLS CUI [1,1]
C0027361
UMLS CUI [1,2]
C0220866
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Similar models

Eligibility Depression NCT01834560

1 Formulaires
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT01834560
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
men and women between 30 and 55 years old
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Childbearing Potential Pregnancy Test
Item
women at a reproductive age will have to be under successful contraceptive and will undergo a pregnancy test before inclusion
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0032976 (UMLS CUI [2,2])
Major Depressive Disorder Unipolar | Conventional Treatment refractory
Item
patient suffering from major unipolar depression refractory to conventional therapies
boolean
C1269683 (UMLS CUI [1,1])
C0443340 (UMLS CUI [1,2])
C2945704 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
Chronic depression | Depressive episode Duration
Item
chronic depression with ongoing depressive episode > 12 months.
boolean
C0581391 (UMLS CUI [1])
C0349217 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Depressive episode Unresponsive to Treatment | Antidepressive Agents | Antidepressive Agents Potentiation | Psychotherapy | Electroconvulsive Therapy
Item
4 unsuccessful therapies attempted to treat the ongoing episode, including anti-depressant monotherapies, potentialisation of antidepressant treatments, validated structured psychotherapies, electro-convulsive therapy performed accordingly to anaes ( agence nationale d'accréditation et d'evaluation en santé-the french health authority) recommendations (at least 6 sessions with bilateral technique and length control of convulsive crisis).
boolean
C0349217 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0003289 (UMLS CUI [2])
C0003289 (UMLS CUI [3,1])
C0086188 (UMLS CUI [3,2])
C0033968 (UMLS CUI [4])
C0013806 (UMLS CUI [5])
Ambulatory care | Hospital care
Item
ambulatory or hospital care
boolean
C0002423 (UMLS CUI [1])
C0259945 (UMLS CUI [2])
Able to speak French language | Comprehension Clinical Trial Procedure | Questionnaires Completion
Item
able to speak french, understand study procedures and complete questionnaires.
boolean
C0564215 (UMLS CUI [1,1])
C0376246 (UMLS CUI [1,2])
C0162340 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0184661 (UMLS CUI [2,3])
C0034394 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
Coverage Health Insurance social France
Item
covered by french social health system
boolean
C1551362 (UMLS CUI [1,1])
C0021682 (UMLS CUI [1,2])
C0728831 (UMLS CUI [1,3])
C0016674 (UMLS CUI [1,4])
Residence | Relocation of home Plan Absent
Item
living in rhone-alpes area without plan to move in the next 2 years
boolean
C0237096 (UMLS CUI [1])
C2699029 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Operation on brain
Item
history of cerebral surgery
boolean
C0195775 (UMLS CUI [1])
Nervous system disorder Interferes with Evaluation Operative Surgical Procedures | Impaired cognition Clinical dementia rating scale
Item
neurological disorder that can interfere with evaluation of surgical procedure or significant cognitive impairment (mattis score < 30)
boolean
C0027765 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
C0543467 (UMLS CUI [1,4])
C0338656 (UMLS CUI [2,1])
C0451074 (UMLS CUI [2,2])
Mental disorder Resulting in Comorbidity Major depressive episode | Schizophrenia | Delirium | Anxiety Except Generalized Anxiety Disorder | Substance Dependence
Item
psychiatric disorder responsible for comorbidity with the major depressive episode (schizophrenia and other delirium, diagnosed anxiety except generalized anxiety disorder, substance dependency)
boolean
C0004936 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0024517 (UMLS CUI [1,4])
C0036341 (UMLS CUI [2])
C0011206 (UMLS CUI [3])
C0003467 (UMLS CUI [4,1])
C0332300 (UMLS CUI [4,2])
C0270549 (UMLS CUI [4,3])
C0038580 (UMLS CUI [5])
Cluster A personality disorder | Cluster B personality disorder
Item
personality disorder of a and b clusters
boolean
C0009084 (UMLS CUI [1])
C0009086 (UMLS CUI [2])
Feeling suicidal | Intention Self-harm | Suicide attempt Repeated | Emergency Care | Hospitalization
Item
suicidal ideas at evaluation, intention for auto-destruction, repeated suicidal attempts in the last 3 years with emergency care or hospitalization
boolean
C0424000 (UMLS CUI [1])
C0162425 (UMLS CUI [2,1])
C0424366 (UMLS CUI [2,2])
C0038663 (UMLS CUI [3,1])
C0205341 (UMLS CUI [3,2])
C1527398 (UMLS CUI [4])
C0019993 (UMLS CUI [5])
Disease Somatic Severe | Medical contraindication Operative Surgical Procedures Due to Defibrillators | Medical contraindication Operative Surgical Procedures Due to Artificial cardiac pacemaker | Medical contraindication Operative Surgical Procedures Due to Implants
Item
severe somatic pathology or contraindication to surgery due to heart defibrillator/pacemaker or other implanted device.
boolean
C0012634 (UMLS CUI [1,1])
C2986476 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0180307 (UMLS CUI [2,4])
C1301624 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0678226 (UMLS CUI [3,3])
C0030163 (UMLS CUI [3,4])
C1301624 (UMLS CUI [4,1])
C0543467 (UMLS CUI [4,2])
C0678226 (UMLS CUI [4,3])
C0021102 (UMLS CUI [4,4])
Hamilton Depression Rating Scale 17 Item Questionnaire Decrease Percentage
Item
a decrease superior to or equal to 20% in the 17-hamilton depression rating scale score between inclusion and pre-surgery evaluation
boolean
C3639712 (UMLS CUI [1,1])
C0547047 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Substance Dependence | Substance Use Disorders | Exception Nicotine
Item
drug dependency including alcohol in the last 12 months with history of abuse in the last 6 months, with the exception of nicotine
boolean
C0038580 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0028040 (UMLS CUI [3,2])
Persons Aspects of laws
Item
persons protected by the law.
boolean
C0027361 (UMLS CUI [1,1])
C0220866 (UMLS CUI [1,2])
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