ID

44740

Beskrivning

rTMS for PTSD Comorbid With Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT02273063

Länk

https://clinicaltrials.gov/show/NCT02273063

Nyckelord

Versioner (1)
  1. 2021-11-10 2021-11-10 -
Rättsinnehavare

Butler Hospital

Uppladdad den

10 november 2021

DOI

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Creative Commons BY-NC 4.0
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Eligibility Posttraumatic Stress Disorder NCT02273063

Engelsk

Eligibility Posttraumatic Stress Disorder NCT02273063

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. to ensure subjects can safely receive rtms, eligible subjects must meet all established screening criteria for safety during mri (magnetic resonance imaging), since mri involves magnetic fields at similar intensity to those emitted from the rtms treatment coil. these are conservative measures require a patient not having the following (unless mri-safe): cardiac pacemaker, implanted device (deep brain stimulation) or metal in the brain, cervical spinal cord, or upper thoracic spinal cord;
Beskrivning

cardiac pacemaker, implanted device or metal in the brain, cervical spinal cord, or upper thoracic spinal cord

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030163
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0021102
UMLS CUI [2,2]
C0006104
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0021102
UMLS CUI [3,2]
C0037925
UMLS CUI [3,3]
C0205064
UMLS CUI [3,4]
C0332197
UMLS CUI [4,1]
C0021102
UMLS CUI [4,2]
C0581269
UMLS CUI [4,3]
C0332197
2. outpatients 18-70 years of age (inclusive)
Beskrivning

age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
3. meet dsm-iv criteria for mdd (recurrent or single episode chronic) and ptsd (acute or chronic) at the time of the screening and baseline visits;
Beskrivning

dsm-iv criteria for mdd and ptsd

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0220952
UMLS CUI [1,2]
C1269683
UMLS CUI [1,3]
C0038436
UMLS CUI [1,4]
C1550543
4. have a baseline score of "moderately ill" or worse on both the cgi-s and the pgi-s.
Beskrivning

cgi-s and pgi-s baseline score of

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3639708
UMLS CUI [1,2]
C1442488
UMLS CUI [1,3]
C0205081
UMLS CUI [2,1]
C0451125
UMLS CUI [2,2]
C1442488
UMLS CUI [2,3]
C0205081
5. have failed at least one antidepressant medication trial as part of definitive and adequate treatment in the current episode, or have demonstrated intolerance to at least one antidepressant medication as part of attempted treatment in the current episode of illness (i.e., meet fda labeling requirements for administration of rtms for depression);
Beskrivning

failed at antidepressant medication trial or intolerance to antidepressant medication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1096649
UMLS CUI [1,2]
C0231175
UMLS CUI [1,3]
C0750480
UMLS CUI [2,1]
C0003289
UMLS CUI [2,2]
C2321306
6. be on a stable psychotropic regimen for at least six weeks (42 days) prior to screening, or no psychotropic medication at all, and be willing to maintain the current regimen and dosing for the duration of the study (unless medical necessary to make changes with notification of research staff);
Beskrivning

stable psychotropic regimen or no psychotropic medication and willingness to maintain it

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0033978
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0033978
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C2348331
UMLS CUI [3,2]
C0521116
UMLS CUI [3,3]
C0008972
UMLS CUI [3,4]
C0449238
UMLS CUI [3,5]
C0600109
7. if female and of child bearing potential, agree to use an acceptable method of birth control for the duration of the study treatment period
Beskrivning

agree to use an acceptable method of birth control

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0086287
UMLS CUI [1,2]
C3831118
UMLS CUI [1,3]
C0700589
UMLS CUI [1,4]
C1879533
UMLS CUI [1,5]
C0600109
8. be willing and able to comply with all study related procedures and visits,
Beskrivning

comply with all study related procedures and visits

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C3714738
UMLS CUI [1,4]
C1511481
UMLS CUI [2,1]
C0008972
UMLS CUI [2,2]
C0545082
UMLS CUI [2,3]
C3714738
UMLS CUI [2,4]
C1511481
9. be capable of independently reading and understanding patient information materials and giving written informed consent.
Beskrivning

written informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. are pregnant or lactating or planning to become pregnant within the next three months.
Beskrivning

pregnant or lactating or planning to become pregnant soon

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0006147
2. have a lifetime history of loss of consciousness due to head injury for greater than 10 minutes, or any lifetime history of loss of consciousness due to a head injury with documented evidence of brain injury (including brain atrophy).
Beskrivning

lifetime history of loss of consciousness due to head injury for greater than 10 minutes, or any lifetime history of loss of consciousness due to a head injury with documented evidence of brain injury

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0041657
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C0018674
UMLS CUI [1,4]
C0449238
UMLS CUI [2,1]
C0041657
UMLS CUI [2,2]
C0262926
UMLS CUI [2,3]
C0018674
UMLS CUI [2,4]
C0332120
UMLS CUI [2,5]
C1301725
UMLS CUI [2,6]
C0270611
3. current (or past if appropriate) significant neurological disorder, or lifetime history of a) seizure disorder b) primary or secondary cns tumors c) stroke or d) cerebral aneurysm;
Beskrivning

neurological disorder or seizure disorder or cns tumors or stroke or cerebral aneurysm

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0521116
UMLS CUI [2,1]
C0036572
UMLS CUI [2,2]
C0262926
UMLS CUI [3,1]
C0085136
UMLS CUI [3,2]
C0262926
UMLS CUI [4,1]
C0038454
UMLS CUI [4,2]
C0262926
UMLS CUI [5,1]
C0917996
UMLS CUI [5,2]
C0262926
4. current axis 1 primary psychotic disorder, or bipolar i disorder, current alcohol and/or substance dependence or abuse within the past 1 month;
Beskrivning

primary psychotic disorder or bipolar disorder, current alcohol and/or substance dependence

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0033975
UMLS CUI [1,2]
C0521116
UMLS CUI [2,1]
C0005586
UMLS CUI [2,2]
C0521116
UMLS CUI [3,1]
C0038580
UMLS CUI [3,2]
C0521116
UMLS CUI [4,1]
C0085762
UMLS CUI [4,2]
C0521116
UMLS CUI [5,1]
C0038580
UMLS CUI [5,2]
C0332185
UMLS CUI [6,1]
C0085762
UMLS CUI [6,2]
C0332185
5. past treatment with tms therapy
Beskrivning

past treatment with tms therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0436548
UMLS CUI [1,2]
C2945691
6. have active suicidal intent or plan as detected on screening assessments, or in the investigator's opinion, is likely to attempt suicide within the next six months.
Beskrivning

suicidal intent as detected on screening assessments or in the investigator's opinion, is likely to attempt suicide within the next six months

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0582496
UMLS CUI [1,2]
C0220908
UMLS CUI [1,3]
C1516048
UMLS CUI [2,1]
C0038663
UMLS CUI [2,2]
C0008961
UMLS CUI [2,3]
C0871010
UMLS CUI [2,4]
C0016884
UMLS CUI [2,5]
C1706276
7. demonstrate the presence of any other condition or circumstance that, in the opinion of the investigator, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments.
Beskrivning

demonstrate the presence of any other condition or circumstance that, in the opinion of the investigator, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0008961
UMLS CUI [1,3]
C0871010
UMLS CUI [1,4]
C1292733
UMLS CUI [1,5]
C2826674
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0008961
UMLS CUI [2,3]
C0871010
UMLS CUI [2,4]
C0009673
UMLS CUI [2,5]
C0085565
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Similar models

Eligibility Posttraumatic Stress Disorder NCT02273063

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
cardiac pacemaker, implanted device or metal in the brain, cervical spinal cord, or upper thoracic spinal cord
Item
1. to ensure subjects can safely receive rtms, eligible subjects must meet all established screening criteria for safety during mri (magnetic resonance imaging), since mri involves magnetic fields at similar intensity to those emitted from the rtms treatment coil. these are conservative measures require a patient not having the following (unless mri-safe): cardiac pacemaker, implanted device (deep brain stimulation) or metal in the brain, cervical spinal cord, or upper thoracic spinal cord;
boolean
C0030163 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0021102 (UMLS CUI [2,1])
C0006104 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0021102 (UMLS CUI [3,1])
C0037925 (UMLS CUI [3,2])
C0205064 (UMLS CUI [3,3])
C0332197 (UMLS CUI [3,4])
C0021102 (UMLS CUI [4,1])
C0581269 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
age
Item
2. outpatients 18-70 years of age (inclusive)
boolean
C0001779 (UMLS CUI [1])
dsm-iv criteria for mdd and ptsd
Item
3. meet dsm-iv criteria for mdd (recurrent or single episode chronic) and ptsd (acute or chronic) at the time of the screening and baseline visits;
boolean
C0220952 (UMLS CUI [1,1])
C1269683 (UMLS CUI [1,2])
C0038436 (UMLS CUI [1,3])
C1550543 (UMLS CUI [1,4])
cgi-s and pgi-s baseline score of
Item
4. have a baseline score of "moderately ill" or worse on both the cgi-s and the pgi-s.
boolean
C3639708 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0205081 (UMLS CUI [1,3])
C0451125 (UMLS CUI [2,1])
C1442488 (UMLS CUI [2,2])
C0205081 (UMLS CUI [2,3])
failed at antidepressant medication trial or intolerance to antidepressant medication
Item
5. have failed at least one antidepressant medication trial as part of definitive and adequate treatment in the current episode, or have demonstrated intolerance to at least one antidepressant medication as part of attempted treatment in the current episode of illness (i.e., meet fda labeling requirements for administration of rtms for depression);
boolean
C1096649 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
C0003289 (UMLS CUI [2,1])
C2321306 (UMLS CUI [2,2])
stable psychotropic regimen or no psychotropic medication and willingness to maintain it
Item
6. be on a stable psychotropic regimen for at least six weeks (42 days) prior to screening, or no psychotropic medication at all, and be willing to maintain the current regimen and dosing for the duration of the study (unless medical necessary to make changes with notification of research staff);
boolean
C0033978 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0033978 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C2348331 (UMLS CUI [3,1])
C0521116 (UMLS CUI [3,2])
C0008972 (UMLS CUI [3,3])
C0449238 (UMLS CUI [3,4])
C0600109 (UMLS CUI [3,5])
agree to use an acceptable method of birth control
Item
7. if female and of child bearing potential, agree to use an acceptable method of birth control for the duration of the study treatment period
boolean
C0086287 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C1879533 (UMLS CUI [1,4])
C0600109 (UMLS CUI [1,5])
comply with all study related procedures and visits
Item
8. be willing and able to comply with all study related procedures and visits,
boolean
C0008972 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C3714738 (UMLS CUI [1,3])
C1511481 (UMLS CUI [1,4])
C0008972 (UMLS CUI [2,1])
C0545082 (UMLS CUI [2,2])
C3714738 (UMLS CUI [2,3])
C1511481 (UMLS CUI [2,4])
written informed consent
Item
9. be capable of independently reading and understanding patient information materials and giving written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
pregnant or lactating or planning to become pregnant soon
Item
1. are pregnant or lactating or planning to become pregnant within the next three months.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
lifetime history of loss of consciousness due to head injury for greater than 10 minutes, or any lifetime history of loss of consciousness due to a head injury with documented evidence of brain injury
Item
2. have a lifetime history of loss of consciousness due to head injury for greater than 10 minutes, or any lifetime history of loss of consciousness due to a head injury with documented evidence of brain injury (including brain atrophy).
boolean
C0041657 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0018674 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,4])
C0041657 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0018674 (UMLS CUI [2,3])
C0332120 (UMLS CUI [2,4])
C1301725 (UMLS CUI [2,5])
C0270611 (UMLS CUI [2,6])
neurological disorder or seizure disorder or cns tumors or stroke or cerebral aneurysm
Item
3. current (or past if appropriate) significant neurological disorder, or lifetime history of a) seizure disorder b) primary or secondary cns tumors c) stroke or d) cerebral aneurysm;
boolean
C0027765 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0036572 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0085136 (UMLS CUI [3,1])
C0262926 (UMLS CUI [3,2])
C0038454 (UMLS CUI [4,1])
C0262926 (UMLS CUI [4,2])
C0917996 (UMLS CUI [5,1])
C0262926 (UMLS CUI [5,2])
primary psychotic disorder or bipolar disorder, current alcohol and/or substance dependence
Item
4. current axis 1 primary psychotic disorder, or bipolar i disorder, current alcohol and/or substance dependence or abuse within the past 1 month;
boolean
C0033975 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0005586 (UMLS CUI [2,1])
C0521116 (UMLS CUI [2,2])
C0038580 (UMLS CUI [3,1])
C0521116 (UMLS CUI [3,2])
C0085762 (UMLS CUI [4,1])
C0521116 (UMLS CUI [4,2])
C0038580 (UMLS CUI [5,1])
C0332185 (UMLS CUI [5,2])
C0085762 (UMLS CUI [6,1])
C0332185 (UMLS CUI [6,2])
past treatment with tms therapy
Item
5. past treatment with tms therapy
boolean
C0436548 (UMLS CUI [1,1])
C2945691 (UMLS CUI [1,2])
suicidal intent as detected on screening assessments or in the investigator's opinion, is likely to attempt suicide within the next six months
Item
6. have active suicidal intent or plan as detected on screening assessments, or in the investigator's opinion, is likely to attempt suicide within the next six months.
boolean
C0582496 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C0038663 (UMLS CUI [2,1])
C0008961 (UMLS CUI [2,2])
C0871010 (UMLS CUI [2,3])
C0016884 (UMLS CUI [2,4])
C1706276 (UMLS CUI [2,5])
demonstrate the presence of any other condition or circumstance that, in the opinion of the investigator, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments
Item
7. demonstrate the presence of any other condition or circumstance that, in the opinion of the investigator, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments.
boolean
C0348080 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C0871010 (UMLS CUI [1,3])
C1292733 (UMLS CUI [1,4])
C2826674 (UMLS CUI [1,5])
C0348080 (UMLS CUI [2,1])
C0008961 (UMLS CUI [2,2])
C0871010 (UMLS CUI [2,3])
C0009673 (UMLS CUI [2,4])
C0085565 (UMLS CUI [2,5])
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