Phase
Condition
Depression
Affective Disorders
Post-traumatic Stress Disorders
Treatment
N/AClinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
To ensure subjects can safely receive rTMS, eligible subjects must meet allestablished screening criteria for safety during MRI (magnetic resonance imaging),since MRI involves magnetic fields at similar intensity to those emitted from the rTMStreatment coil. These are conservative measures require a patient not having thefollowing (unless MRI-safe): Cardiac pacemaker, implanted device (deep brainstimulation) or metal in the brain, cervical spinal cord, or upper thoracic spinalcord;
Outpatients 18-70 years of age (inclusive)
Meet DSM-IV criteria for MDD (recurrent or single episode chronic) and PTSD (acute orchronic) at the time of the screening and baseline visits;
Have a baseline score of "Moderately Ill" or worse on both the CGI-S and the PGI-S.
Have failed at least one antidepressant medication trial as part of definitive andadequate treatment in the current episode, OR have demonstrated intolerance to atleast one antidepressant medication as part of attempted treatment in the currentepisode of illness (i.e., meet FDA labeling requirements for administration of rTMSfor depression);
Be on a stable psychotropic regimen for at least six weeks (42 days) prior toscreening, or no psychotropic medication at all, and be willing to maintain thecurrent regimen and dosing for the duration of the study (unless medical necessary tomake changes with notification of research staff);
If female and of child bearing potential, agree to use an acceptable method of birthcontrol for the duration of the study treatment period
Be willing and able to comply with all study related procedures and visits,
Be capable of independently reading and understanding patient information materialsand giving written informed consent.
Exclusion
Exclusion Criteria:
Are pregnant or lactating or planning to become pregnant within the next three months.
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 withdocumented evidence of brain injury (including brain atrophy).
Current (or past if appropriate) significant neurological disorder, or lifetimehistory of a) seizure disorder b) primary or secondary CNS tumors c) stroke or d)cerebral aneurysm;
Current Axis 1 primary psychotic disorder, or bipolar I disorder, current alcoholand/or substance dependence or abuse within the past 1 month;
Past treatment with TMS therapy
Have active suicidal intent or plan as detected on screening assessments, or in theInvestigator's opinion, is likely to attempt suicide within the next six months.
Demonstrate the presence of any other condition or circumstance that, in the opinionof the investigator, has the potential to prevent study completion and/or to have aconfounding effect on outcome assessments.
Study Design
Study Description
Connect with a study center
Butler Hospital
Providence, Rhode Island 02906
United StatesSite Not Available
Providence VA Medical Center
Providence, Rhode Island 02908
United StatesSite Not Available

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