ID

23488

Beschrijving

Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Panic Disorder With Comorbid Major Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00521352

Link

https://clinicaltrials.gov/show/NCT00521352

Trefwoorden

Versies (1)
  1. 08-07-17 08-07-17 -
Geüploaded op

8 juli 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Panic Disorder NCT00521352

Engels

Eligibility Panic Disorder NCT00521352

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with a primary diagnosis of panic disorder and major depressive disorder, as confirmed by the structured clinical interview for the dsm-iv-tr (scid)
Beschrijving

ID.1

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030319
UMLS CUI [1,2]
C1269683
residual panic attacks and mdd symptoms, defined as a total pdss score of ≥ 20 and hdrs-17 score ≥18, despite treatment with an adequate trial of a serotonin reuptake inhibitor (sri)
Beschrijving

ID.2

Datatype

boolean

Alias
UMLS CUI [1,1]
C0086769
UMLS CUI [1,2]
C1269683
UMLS CUI [1,3]
C0162758
a duration of the index episode of at least a month will be included.
Beschrijving

ID.3

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C0086769
an adequate sri trial is defined as treatment for at least 6-8 weeks on the sri, that meets the maximum recommended dosage level for pd and mdd (fluoxetine 40-60 mg/d, sertraline 100-200 mg/d, paroxetine 40-60 mg/d, fluvoxamine 200-300 mg/d, citalopram 40-60 mg/d, escitalopram 20-30 mg/d).
Beschrijving

ID.4

Datatype

boolean

Alias
UMLS CUI [1]
C0162758
individuals who cannot tolerate medications of class and dose at the specified duration as described above will also be included.
Beschrijving

ID.5

Datatype

boolean

Alias
UMLS CUI [1,1]
C0162758
UMLS CUI [1,2]
C0449238
patients currently on medication must be at the same stable dose(s) for one month prior to enrollment and be willing to continue at the same dose(s) through the duration of the study.
Beschrijving

ID.6

Datatype

boolean

Alias
UMLS CUI [1]
C0178602
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
individuals diagnosed with bipolar disorder (lifetime), any psychotic disorder (lifetime), or an axis ii personality disorder
Beschrijving

ID.7

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005586
UMLS CUI [1,2]
C0033975
UMLS CUI [1,3]
C0031212
a history of substance abuse or dependence within the past year (except nicotine and caffeine)
Beschrijving

ID.8

Datatype

boolean

Alias
UMLS CUI [1]
C0740858
significant acute suicide risk will be excluded.
Beschrijving

ID.9

Datatype

boolean

Alias
UMLS CUI [1]
C0563664
individuals with a clinically defined neurological disorder, with an increased risk of seizure for any reason, with a history of treatment with tms, deep brain stimulation for any disorder will be excluded.
Beschrijving

ID.11

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0036572
UMLS CUI [1,3]
C0436548
UMLS CUI [1,4]
C0394162
patients with cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed will be excluded.
Beschrijving

ID.12

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021102
UMLS CUI [1,2]
C0018799
current use of any investigational drug, any medications with proconvulsive action, such as bupropion, maprotiline, tricyclic antidepressant, clomipramine, classical antipsychotics, and daily use of any medications with a known inhibitory effect on cortical excitability measures (e.g., anticonvulsants, standing doses of benzodiazepines, sedative/hypnotics, and atypical antipsychotics) will not be permitted.
Beschrijving

ID.13

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0234531
UMLS CUI [1,3]
C0013227
if participating in psychotherapy, patients must have been in stable treatment for at least three months prior to entry into the study, with no anticipation of change in frequency therapeutic sessions, or the therapeutic focus over the duration of the tms trial.
Beschrijving

ID.14

Datatype

boolean

Alias
UMLS CUI [1]
C0033968
finally, current significant laboratory abnormality, known or suspected pregnancy, women who are breast-feeding or women of childbearing potential not using a medically accepted form of contraception when engaging in sexual intercourse will also be excluded.
Beschrijving

ID.15

Datatype

boolean

Alias
UMLS CUI [1,1]
C0281768
UMLS CUI [1,2]
C0006147
UMLS CUI [1,3]
C0032961
UMLS CUI [1,4]
C0009862
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Similar models

Eligibility Panic Disorder NCT00521352

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
patients with a primary diagnosis of panic disorder and major depressive disorder, as confirmed by the structured clinical interview for the dsm-iv-tr (scid)
boolean
C0030319 (UMLS CUI [1,1])
C1269683 (UMLS CUI [1,2])
ID.2
Item
residual panic attacks and mdd symptoms, defined as a total pdss score of ≥ 20 and hdrs-17 score ≥18, despite treatment with an adequate trial of a serotonin reuptake inhibitor (sri)
boolean
C0086769 (UMLS CUI [1,1])
C1269683 (UMLS CUI [1,2])
C0162758 (UMLS CUI [1,3])
ID.3
Item
a duration of the index episode of at least a month will be included.
boolean
C0332189 (UMLS CUI [1,1])
C0086769 (UMLS CUI [1,2])
ID.4
Item
an adequate sri trial is defined as treatment for at least 6-8 weeks on the sri, that meets the maximum recommended dosage level for pd and mdd (fluoxetine 40-60 mg/d, sertraline 100-200 mg/d, paroxetine 40-60 mg/d, fluvoxamine 200-300 mg/d, citalopram 40-60 mg/d, escitalopram 20-30 mg/d).
boolean
C0162758 (UMLS CUI [1])
ID.5
Item
individuals who cannot tolerate medications of class and dose at the specified duration as described above will also be included.
boolean
C0162758 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
ID.6
Item
patients currently on medication must be at the same stable dose(s) for one month prior to enrollment and be willing to continue at the same dose(s) through the duration of the study.
boolean
C0178602 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.7
Item
individuals diagnosed with bipolar disorder (lifetime), any psychotic disorder (lifetime), or an axis ii personality disorder
boolean
C0005586 (UMLS CUI [1,1])
C0033975 (UMLS CUI [1,2])
C0031212 (UMLS CUI [1,3])
ID.8
Item
a history of substance abuse or dependence within the past year (except nicotine and caffeine)
boolean
C0740858 (UMLS CUI [1])
ID.9
Item
significant acute suicide risk will be excluded.
boolean
C0563664 (UMLS CUI [1])
ID.11
Item
individuals with a clinically defined neurological disorder, with an increased risk of seizure for any reason, with a history of treatment with tms, deep brain stimulation for any disorder will be excluded.
boolean
C0027765 (UMLS CUI [1,1])
C0036572 (UMLS CUI [1,2])
C0436548 (UMLS CUI [1,3])
C0394162 (UMLS CUI [1,4])
ID.12
Item
patients with cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed will be excluded.
boolean
C0021102 (UMLS CUI [1,1])
C0018799 (UMLS CUI [1,2])
ID.13
Item
current use of any investigational drug, any medications with proconvulsive action, such as bupropion, maprotiline, tricyclic antidepressant, clomipramine, classical antipsychotics, and daily use of any medications with a known inhibitory effect on cortical excitability measures (e.g., anticonvulsants, standing doses of benzodiazepines, sedative/hypnotics, and atypical antipsychotics) will not be permitted.
boolean
C0013230 (UMLS CUI [1,1])
C0234531 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
ID.14
Item
if participating in psychotherapy, patients must have been in stable treatment for at least three months prior to entry into the study, with no anticipation of change in frequency therapeutic sessions, or the therapeutic focus over the duration of the tms trial.
boolean
C0033968 (UMLS CUI [1])
ID.15
Item
finally, current significant laboratory abnormality, known or suspected pregnancy, women who are breast-feeding or women of childbearing potential not using a medically accepted form of contraception when engaging in sexual intercourse will also be excluded.
boolean
C0281768 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
C0009862 (UMLS CUI [1,4])
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