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])
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])