Adaptive Design Study of NEST sTMS in Subjects With Major Depressive Disorder
Adaptive Design Study of NEST sTMS in Subjects With Major Depressive Disorder
This is a double-blind, sham controlled, multi-center study to confirm the safety and
 efficacy of synchronized transcranial magnetic stimulation (sTMS) for the treatment of
 patients currently experiencing an episode of depression who have failed to respond to at
 least one (1) antidepressant medication. Patients will be randomly assigned to either active
 or sham therapy and will undergo daily treatments for a period of time. Following completion
 of blinded treatments, patients may be eligible for a course of open label treatments.
Inclusion Criteria:

 -  Current episode of Major Depressive Disorder

 -  Inadequate response to at least one antidepressant medication in the current episode
 (Treatment Resistant Depression)

 -  Investigator able to identify IAF using EEG

 -  Willingness and ability to adhere to treatment schedule (5 treatments per week for six
 weeks)

 Exclusion Criteria:

 -  Unable to unwilling to give informed consent

 -  Diagnosed with excluded conditions or treatment histories

 -  Currently hospitalized due to severity of depression symptoms

 -  Use of prohibited medications (as defined by protocol) within specified time frame of
 randomization

 -  Use of certain cardiac devices

 -  Use of certain intracranial devices

 -  Currently pregnant or unwilling to practice acceptable means of birth control, and
 women who are breastfeeding