ID

20836

Beschrijving

rEEG Guided Pharmacotherapy of Subjects With Depression Treatment Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00437827

Link

https://clinicaltrials.gov/show/NCT00437827

Trefwoorden

  1. 21-03-17 21-03-17 -
Geüploaded op

21 maart 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Depressive Disorder NCT00437827

Eligibility Depressive Disorder NCT00437827

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. 18 years of age or older.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
2. diagnosis of major depressive disorder validated by scid. subjects may meet criteria for both melancholic and atypical depression per this protocol.
Beschrijving

Major depressive disorder

Datatype

boolean

Alias
UMLS CUI [1]
C1269683
3. have failed three or more antidepressant regimens during the current depressive episode with minimum daily dose(s) as defined in the medication history for depression case report form and for a minimum duration of treatment of at least 4 weeks. for purposes of the study, augmentation will be considered a separate regimen.
Beschrijving

Antidepressive therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C0087111
4. able to stop all medications for 5 half-lives of the medication(s), with the exception of hormones, thyroid, hydrochlorthiazide and ambien. see appendix ii for a list of the half-lives of medications.
Beschrijving

Discontinued pharmacotherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C1444662
UMLS CUI [1,2]
C0013216
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history of: closed head injury with unconsciousness, craniotomy, cerebral metastases, cerebrovascular accident; no current diagnosis of seizure disorder, bipolar disorder, schizophrenia, dementia, mental retardation, substance abuse, or major depression with psychotic features; or use of depot neuroleptics in last 12 months.
Beschrijving

Neurological disease or mental disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0004936
2. participation in any other therapeutic drug study evaluating a treatment for depression within 60 days preceding inclusion, unless drug(s) half-life is known.
Beschrijving

Study participation status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
3. known pregnancy and/or lactation, or intent to become pregnant during this study.
Beschrijving

Gynaecological status

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
4. doesn't qualify via reeg analysis due to:
Beschrijving

EEG analysis

Datatype

boolean

Alias
UMLS CUI [1]
C0374458
potential physiologic abnormality
Beschrijving

Physiological abnormality

Datatype

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0205463
low abnormality in comparison to current reeg database
Beschrijving

Low abnormality

Datatype

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0205251
no strong prediction by reeg analysis for any particular medication class
Beschrijving

Prediction

Datatype

boolean

Alias
UMLS CUI [1]
C0681842

Similar models

Eligibility Depressive Disorder NCT00437827

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. 18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
Major depressive disorder
Item
2. diagnosis of major depressive disorder validated by scid. subjects may meet criteria for both melancholic and atypical depression per this protocol.
boolean
C1269683 (UMLS CUI [1])
Antidepressive therapy
Item
3. have failed three or more antidepressant regimens during the current depressive episode with minimum daily dose(s) as defined in the medication history for depression case report form and for a minimum duration of treatment of at least 4 weeks. for purposes of the study, augmentation will be considered a separate regimen.
boolean
C0003289 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Discontinued pharmacotherapy
Item
4. able to stop all medications for 5 half-lives of the medication(s), with the exception of hormones, thyroid, hydrochlorthiazide and ambien. see appendix ii for a list of the half-lives of medications.
boolean
C1444662 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Neurological disease or mental disorder
Item
1. history of: closed head injury with unconsciousness, craniotomy, cerebral metastases, cerebrovascular accident; no current diagnosis of seizure disorder, bipolar disorder, schizophrenia, dementia, mental retardation, substance abuse, or major depression with psychotic features; or use of depot neuroleptics in last 12 months.
boolean
C0027765 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
Study participation status
Item
2. participation in any other therapeutic drug study evaluating a treatment for depression within 60 days preceding inclusion, unless drug(s) half-life is known.
boolean
C2348568 (UMLS CUI [1])
Gynaecological status
Item
3. known pregnancy and/or lactation, or intent to become pregnant during this study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
EEG analysis
Item
4. doesn't qualify via reeg analysis due to:
boolean
C0374458 (UMLS CUI [1])
Physiological abnormality
Item
potential physiologic abnormality
boolean
C1704258 (UMLS CUI [1,1])
C0205463 (UMLS CUI [1,2])
Low abnormality
Item
low abnormality in comparison to current reeg database
boolean
C1704258 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
Prediction
Item
no strong prediction by reeg analysis for any particular medication class
boolean
C0681842 (UMLS CUI [1])

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