Low Field Magnetic Stimulation (LFMS) in Subjects With Treatment-Resistant Depression (TRD)

Exclusion Criteria

• •Have failed four or more lifetime adequate ADT treatment regimens (including the ongoing ADT for the current MDE).
• •Have been treated with adjunctive antipsychotic medication with an antidepressant for at least two weeks during the current depressive episode.
• •Are deemed to be at significant risk for suicidal behavior
• •Are unable to lie on their back for the duration of study treatment
• •Have a lifetime history of:
• •1. Delirium, dementia, amnestic, or other cognitive disorder;
• •2. Schizophrenia or any psychotic disorder, based on the Structured Clinical Interview for DSM-5 Axis I Disorders Patient Edition (SCID-I/P);
• •3. Bipolar I or II disorder, based on the SCID-I/P.
• •Have a current DSM-5 diagnosis at the screening visit (Visit 1) of:
• •1. An eating disorder active within the 12 months prior to the screening visit (Visit 1);
• •2. Comorbid anxiety disorders that predominate over MDD, as assessed by the investigator;
• •3. Alcohol or substance use disorder active within the 12 months prior to the screening visit (Visit 1);
• •4. Clinically significant DSM-5 Axis II disorder.
• •Have ever received electroconvulsive therapy, vagal nerve stimulation, deep brain stimulation or repetitive transcranial magnetic stimulation.
• •Have a non-removable programmable device or appliance such as cardiac pacemakers or cochlear implants.
• •Have any non-removable ferromagnetic implants, or conductive or other magnetic sensitive materials present in the head or neck .
• •Have a lifetime history of seizures or clinically significant electroencephalography abnormalities. A history of childhood febrile seizures is permitted.