ID

13195

Beschrijving

Neurophysiologic Monitoring of Antidepressant Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT01360190

Link

https://clinicaltrials.gov/show/NCT01360190

Trefwoorden

  1. 23-01-16 23-01-16 -
Geüploaded op

23 januari 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Major Depressive Disorder NCT01360190

Eligibility Major Depressive Disorder NCT01360190

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
all subjects will meet dsm-iv criteria for major depression based upon the structured clinical interview for dsm-iv - patient version (scid-p) (first et al., 1994). all research personnel have undergone scid-p training, and soon will extend this training to the dsm-iv version.
Beschrijving

major depression

Datatype

boolean

Alias
UMLS CUI [1]
C1269683
subjects also will have a score on the 17-item hamilton depression rating scale of > 18 (with item #1 > 2).
Beschrijving

hamd

Datatype

boolean

Alias
UMLS CUI [1]
C0451203
all subjects will be under the care of a clinician not affiliated with the study at the time of entry into the study, and through the course of the study.
Beschrijving

clinician care

Datatype

boolean

Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects will have no serious medical illness.
Beschrijving

serious medical illness

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
we will exclude patients also meeting criteria for the following groups of axis i diagnoses: delirium or dementia, substance-related disorders, schizophrenia or other psychotic disorders, or eating disorders.
Beschrijving

axis i diagnoses

Datatype

boolean

Alias
UMLS CUI [1]
C0270287
UMLS CUI [2]
C0011206
UMLS CUI [3]
C0497327
UMLS CUI [4]
C0236969
UMLS CUI [5]
C0036341
UMLS CUI [6]
C0033975
UMLS CUI [7]
C0013473
in addition, patients meeting criteria for cluster a or b axis ii diagnoses will be excluded.
Beschrijving

axis ii diagnoses

Datatype

boolean

Alias
UMLS CUI [1]
C0270288
subjects with a history of current or past active suicidal ideation, or suicide attempts will be excluded, as will patients who previously have failed to respond to an adequate clinical trial of fluoxetine, or have failed to tolerate the medication.
Beschrijving

suicidal, fluoxetin response

Datatype

boolean

Alias
UMLS CUI [1]
C0438696
UMLS CUI [2]
C0016365
UMLS CUI [3]
C0521982
subjects who have had suboptimal trials, however, may still be considered for the study.
Beschrijving

suboptimal trials

Datatype

boolean

Similar models

Eligibility Major Depressive Disorder NCT01360190

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
major depression
Item
all subjects will meet dsm-iv criteria for major depression based upon the structured clinical interview for dsm-iv - patient version (scid-p) (first et al., 1994). all research personnel have undergone scid-p training, and soon will extend this training to the dsm-iv version.
boolean
C1269683 (UMLS CUI [1])
hamd
Item
subjects also will have a score on the 17-item hamilton depression rating scale of > 18 (with item #1 > 2).
boolean
C0451203 (UMLS CUI [1])
clinician care
Item
all subjects will be under the care of a clinician not affiliated with the study at the time of entry into the study, and through the course of the study.
boolean
Item Group
C0680251 (UMLS CUI)
serious medical illness
Item
subjects will have no serious medical illness.
boolean
C0009488 (UMLS CUI [1])
axis i diagnoses
Item
we will exclude patients also meeting criteria for the following groups of axis i diagnoses: delirium or dementia, substance-related disorders, schizophrenia or other psychotic disorders, or eating disorders.
boolean
C0270287 (UMLS CUI [1])
C0011206 (UMLS CUI [2])
C0497327 (UMLS CUI [3])
C0236969 (UMLS CUI [4])
C0036341 (UMLS CUI [5])
C0033975 (UMLS CUI [6])
C0013473 (UMLS CUI [7])
axis ii diagnoses
Item
in addition, patients meeting criteria for cluster a or b axis ii diagnoses will be excluded.
boolean
C0270288 (UMLS CUI [1])
suicidal, fluoxetin response
Item
subjects with a history of current or past active suicidal ideation, or suicide attempts will be excluded, as will patients who previously have failed to respond to an adequate clinical trial of fluoxetine, or have failed to tolerate the medication.
boolean
C0438696 (UMLS CUI [1])
C0016365 (UMLS CUI [2])
C0521982 (UMLS CUI [3])
suboptimal trials
Item
subjects who have had suboptimal trials, however, may still be considered for the study.
boolean

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