ID

15110

Beschreibung

A Clinical Trial of Magnetic Stimulation in Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00711568

Link

https://clinicaltrials.gov/show/NCT00711568

Stichworte

Versionen (2)
  1. 14.05.16 14.05.16 -
  2. 16.05.16 16.05.16 -
Hochgeladen am

16. Mai 2016

DOI

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Creative Commons BY 4.0
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Eligibility Depression NCT00711568

Englisch

Eligibility Depression NCT00711568

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00711568
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
all patients will meet dsm-iv criteria for major depressive episode (without psychotic features).
Beschreibung

dsm-iv

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011581
UMLS CUI [1,2]
C0220952
all patients will have a total score of 18 or higher and a score of at least 3 on item number 1 of the 24 item hamilton rating scale for depression (ham-d).
Beschreibung

hamilton rating scale

Datentyp

boolean

Alias
UMLS CUI [1]
C0451203
all patients will have failed to respond to at least two separate trials of treatment for at least 4 weeks with therapeutic dosages of antidepressant medication (including at least one ssri) or will have been intolerant of at least three different antidepressant medications (including at least one ssri).
Beschreibung

antidepressant treatment failure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C0679864
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient medications will be reviewed prior to enrollment in this study. patients taking medications that may lower seizure threshold (e.g. metronidazole) will be excluded if the particular medication cannot be stopped or altered without affecting the patient's routine medical care.
Beschreibung

seizure threshold lowering medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0234976
UMLS CUI [1,2]
C0013227
history of neurological illness, epilepsy or seizure disorder, intracranial tumor, or major head trauma leading to loss of consciousness of any length.
Beschreibung

neurological illness; epilepsy; seizure disorder;

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0517960
UMLS CUI [1,2]
C0027765
UMLS CUI [2,1]
C0517960
UMLS CUI [2,2]
C0014544
UMLS CUI [3,1]
C0517960
UMLS CUI [3,2]
C0036572
UMLS CUI [4,1]
C0517960
UMLS CUI [4,2]
C1527390
UMLS CUI [5,1]
C0517960
UMLS CUI [5,2]
C0018674
evidence of central nervous system disease based on baseline complete neurological examination, eeg and contrast-enhanced computerized tomography or magnetic resonance imaging of the brain.
Beschreibung

cns disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0007682
history of implanted pacemaker or medication pump, metal plate in skull, or metal objects in the eye or skull.
Beschreibung

pacemaker; medication pump; metal implants in head

Datentyp

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C2076930
UMLS CUI [3,1]
C0336580
UMLS CUI [3,2]
C0018670
axis ii diagnosis of cluster a (paranoid, schizoid, or schizotypal) or cluster b (antisocial, borderline, histrionic, or narcissistic) personality disorder.
Beschreibung

personality disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0031212
axis ii diagnosis of mental retardation.
Beschreibung

mental retardation axis 2

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0025362
UMLS CUI [1,2]
C0945856
history of schizophrenia, schizoaffective disorder, other functional psychosis, rapid-cycling bipolar illness, or alcohol or drug abuse within the past year.
Beschreibung

schizophrenia, schizoaffective disorder, other functional psychosis, rapid-cycling bipolar illness, or alcohol or drug abuse

Datentyp

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036337
UMLS CUI [3]
C0033975
UMLS CUI [4]
C0005586
UMLS CUI [5]
C0085762
UMLS CUI [6]
C0013146
need for rapid clinical response due to conditions such as inanition, psychosis, or suicidality (defined as suicide attempt during the current major depressive episode or having a specific plan for committing suicide).
Beschreibung

rapid clinical response necessary

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4055223
UMLS CUI [1,2]
C0456962
a medical condition that is not well controlled, such as diabetes or hypertension, or concomitant medical or nutritional problems necessitating hospitalization.
Beschreibung

uncontrolled medical condition

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205318
patients taking anticonvulsant mood stabilizers (e.g. carbamazepine, valproic acid).
Beschreibung

anticonvulsants

Datentyp

boolean

Alias
UMLS CUI [1]
C0003286
patients otherwise unable to grant informed consent.
Beschreibung

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
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Ähnliche Modelle

Eligibility Depression NCT00711568

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00711568
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
dsm-iv
Item
all patients will meet dsm-iv criteria for major depressive episode (without psychotic features).
boolean
C0011581 (UMLS CUI [1,1])
C0220952 (UMLS CUI [1,2])
hamilton rating scale
Item
all patients will have a total score of 18 or higher and a score of at least 3 on item number 1 of the 24 item hamilton rating scale for depression (ham-d).
boolean
C0451203 (UMLS CUI [1])
antidepressant treatment failure
Item
all patients will have failed to respond to at least two separate trials of treatment for at least 4 weeks with therapeutic dosages of antidepressant medication (including at least one ssri) or will have been intolerant of at least three different antidepressant medications (including at least one ssri).
boolean
C0003289 (UMLS CUI [1,1])
C0679864 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
seizure threshold lowering medication
Item
patient medications will be reviewed prior to enrollment in this study. patients taking medications that may lower seizure threshold (e.g. metronidazole) will be excluded if the particular medication cannot be stopped or altered without affecting the patient's routine medical care.
boolean
C0234976 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
neurological illness; epilepsy; seizure disorder;
Item
history of neurological illness, epilepsy or seizure disorder, intracranial tumor, or major head trauma leading to loss of consciousness of any length.
boolean
C0517960 (UMLS CUI [1,1])
C0027765 (UMLS CUI [1,2])
C0517960 (UMLS CUI [2,1])
C0014544 (UMLS CUI [2,2])
C0517960 (UMLS CUI [3,1])
C0036572 (UMLS CUI [3,2])
C0517960 (UMLS CUI [4,1])
C1527390 (UMLS CUI [4,2])
C0517960 (UMLS CUI [5,1])
C0018674 (UMLS CUI [5,2])
cns disease
Item
evidence of central nervous system disease based on baseline complete neurological examination, eeg and contrast-enhanced computerized tomography or magnetic resonance imaging of the brain.
boolean
C0007682 (UMLS CUI [1])
pacemaker; medication pump; metal implants in head
Item
history of implanted pacemaker or medication pump, metal plate in skull, or metal objects in the eye or skull.
boolean
C0030163 (UMLS CUI [1])
C2076930 (UMLS CUI [2])
C0336580 (UMLS CUI [3,1])
C0018670 (UMLS CUI [3,2])
personality disorder
Item
axis ii diagnosis of cluster a (paranoid, schizoid, or schizotypal) or cluster b (antisocial, borderline, histrionic, or narcissistic) personality disorder.
boolean
C0031212 (UMLS CUI [1])
mental retardation axis 2
Item
axis ii diagnosis of mental retardation.
boolean
C0025362 (UMLS CUI [1,1])
C0945856 (UMLS CUI [1,2])
schizophrenia, schizoaffective disorder, other functional psychosis, rapid-cycling bipolar illness, or alcohol or drug abuse
Item
history of schizophrenia, schizoaffective disorder, other functional psychosis, rapid-cycling bipolar illness, or alcohol or drug abuse within the past year.
boolean
C0036341 (UMLS CUI [1])
C0036337 (UMLS CUI [2])
C0033975 (UMLS CUI [3])
C0005586 (UMLS CUI [4])
C0085762 (UMLS CUI [5])
C0013146 (UMLS CUI [6])
rapid clinical response necessary
Item
need for rapid clinical response due to conditions such as inanition, psychosis, or suicidality (defined as suicide attempt during the current major depressive episode or having a specific plan for committing suicide).
boolean
C4055223 (UMLS CUI [1,1])
C0456962 (UMLS CUI [1,2])
uncontrolled medical condition
Item
a medical condition that is not well controlled, such as diabetes or hypertension, or concomitant medical or nutritional problems necessitating hospitalization.
boolean
C0012634 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
anticonvulsants
Item
patients taking anticonvulsant mood stabilizers (e.g. carbamazepine, valproic acid).
boolean
C0003286 (UMLS CUI [1])
informed consent
Item
patients otherwise unable to grant informed consent.
boolean
C0021430 (UMLS CUI [1])
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