ID

31811

Beskrivning

DBS in Treatment Resistant Major Depression; ODM derived from: https://clinicaltrials.gov/show/NCT01268137

Länk

https://clinicaltrials.gov/show/NCT01268137

Nyckelord

Versioner (1)
  1. 2018-09-30 2018-09-30 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

30 september 2018

DOI

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Creative Commons BY 4.0
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Eligibility Resistant Major Depressive Disorder NCT01268137

Engelsk

Eligibility Resistant Major Depressive Disorder NCT01268137

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients of both sexes aged between 18 and 70 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. patients diagnosed as having an mdd episode according to dsm-iv-tr criteria, resistant to pharmacological treatment with a score of 4 in the thase-rush index, with ect contraindicated or having failed to produce a maintained response.
Beskrivning

Major depressive episode Resistant to Pharmacotherapy | Other Coding | ECT Contraindicated | ECT Response failed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024517
UMLS CUI [1,2]
C0332325
UMLS CUI [1,3]
C0013216
UMLS CUI [2]
C3846158
UMLS CUI [3,1]
C0013806
UMLS CUI [3,2]
C1444657
UMLS CUI [4,1]
C0013806
UMLS CUI [4,2]
C1704632
UMLS CUI [4,3]
C0231175
3. patients with a hrsd-17 score of 18 or more.
Beskrivning

Hamilton Depression Rating Scale 17 Item Clinical Classification

Datatyp

boolean

Alias
UMLS CUI [1]
C3639712
4. patients with an intellectual capacity that facilitates adequate communication and who are willing to cooperate with all the examinations and protocols of the study.
Beskrivning

Intellectual ability Communication Adequate | Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0423898
UMLS CUI [1,2]
C0009452
UMLS CUI [1,3]
C0205411
UMLS CUI [2]
C0525058
5. patients who have not modified their antidepressant treatment in the month prior to the study.
Beskrivning

Antidepressant therapy unchanged

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1096649
UMLS CUI [1,2]
C0442739
6. women of childbearing age using medically approved contraceptive methods.
Beskrivning

Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
7. patients who have granted their informed consent in writing.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. female patients who are pregnant or breastfeeding.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. patients with acute, serious or unstable illnesses.
Beskrivning

Illness | Illness Serious | Illness Unstable

Datatyp

boolean

Alias
UMLS CUI [1]
C0221423
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205404
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C0443343
3. patients experiencing delirium or hallucinations, congruent or otherwise with their mood.
Beskrivning

Delirium | Hallucinations, Mood Congruent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011206
UMLS CUI [2]
C0233775
4. patients with a history of substance abuse (other than tobacco or caffeine).
Beskrivning

Substance Use Disorders | Exception Tobacco Use Disorder | Exception Caffeine abuse

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0040336
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0679260
5. patients with concomitant psychiatric disorders from axes i or ii of dsm iv-tr.
Beskrivning

Axis I diagnosis | Axis II diagnosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0270287
UMLS CUI [2]
C0270288
h)patients with general contraindications for dbs (pacemaker users, etc).
Beskrivning

Medical contraindication Deep Brain Stimulation | Artificial cardiac pacemaker user

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0394162
UMLS CUI [2]
C0919812
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Similar models

Eligibility Resistant Major Depressive Disorder NCT01268137

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. patients of both sexes aged between 18 and 70 years.
boolean
C0001779 (UMLS CUI [1])
Major depressive episode Resistant to Pharmacotherapy | Other Coding | ECT Contraindicated | ECT Response failed
Item
2. patients diagnosed as having an mdd episode according to dsm-iv-tr criteria, resistant to pharmacological treatment with a score of 4 in the thase-rush index, with ect contraindicated or having failed to produce a maintained response.
boolean
C0024517 (UMLS CUI [1,1])
C0332325 (UMLS CUI [1,2])
C0013216 (UMLS CUI [1,3])
C3846158 (UMLS CUI [2])
C0013806 (UMLS CUI [3,1])
C1444657 (UMLS CUI [3,2])
C0013806 (UMLS CUI [4,1])
C1704632 (UMLS CUI [4,2])
C0231175 (UMLS CUI [4,3])
Hamilton Depression Rating Scale 17 Item Clinical Classification
Item
3. patients with a hrsd-17 score of 18 or more.
boolean
C3639712 (UMLS CUI [1])
Intellectual ability Communication Adequate | Protocol Compliance
Item
4. patients with an intellectual capacity that facilitates adequate communication and who are willing to cooperate with all the examinations and protocols of the study.
boolean
C0423898 (UMLS CUI [1,1])
C0009452 (UMLS CUI [1,2])
C0205411 (UMLS CUI [1,3])
C0525058 (UMLS CUI [2])
Antidepressant therapy unchanged
Item
5. patients who have not modified their antidepressant treatment in the month prior to the study.
boolean
C1096649 (UMLS CUI [1,1])
C0442739 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods
Item
6. women of childbearing age using medically approved contraceptive methods.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Informed Consent
Item
7. patients who have granted their informed consent in writing.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
1. female patients who are pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Illness | Illness Serious | Illness Unstable
Item
2. patients with acute, serious or unstable illnesses.
boolean
C0221423 (UMLS CUI [1])
C0221423 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0221423 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
Delirium | Hallucinations, Mood Congruent
Item
3. patients experiencing delirium or hallucinations, congruent or otherwise with their mood.
boolean
C0011206 (UMLS CUI [1])
C0233775 (UMLS CUI [2])
Substance Use Disorders | Exception Tobacco Use Disorder | Exception Caffeine abuse
Item
4. patients with a history of substance abuse (other than tobacco or caffeine).
boolean
C0038586 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0040336 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0679260 (UMLS CUI [3,2])
Axis I diagnosis | Axis II diagnosis
Item
5. patients with concomitant psychiatric disorders from axes i or ii of dsm iv-tr.
boolean
C0270287 (UMLS CUI [1])
C0270288 (UMLS CUI [2])
Medical contraindication Deep Brain Stimulation | Artificial cardiac pacemaker user
Item
h)patients with general contraindications for dbs (pacemaker users, etc).
boolean
C1301624 (UMLS CUI [1,1])
C0394162 (UMLS CUI [1,2])
C0919812 (UMLS CUI [2])
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