Table 1 rTMS trial inclusion and exclusion criteria

Between 18 and 80 years of age.

Pregnant or lactating woman (this is an FDA-required exclusion. In the future, if rTMS becomes a proven treatment for major depression, its safety in the context of pregnancy should be studied separately)

Using the Structured Clinical Interview for DSM Disorders (SCID) for DSM-IV-TR patients will be diagnosed MDD

Unable to be safely withdrawn, at least 2 weeks prior to treatment commencement, from medications that substantially increase the risk of having seizures

Have a HRSD24 ≥ 20 no more than 7 days prior to randomization

Have a cardiac pacemaker

Exhibit moderate level of resistance to antidepressant treatment defined, using the ATHF, as failure of at least two adequate medication trials

Have an implanted device or metal in the brain

Duration of current episode of MDD ≤ 10 years

Have a cochlear implant

Ability to obtain a motor threshold (MT) (should be determined at the end of the screening process)

Have a mass lesion, cerebral infarct, increased intracranial pressure, or other active central nervous system (CNS) disease, including a seizure disorder

Currently under the care of a VA psychiatrist

Known current psychosis as determined by DSM-IV or SCID (axis I, psychotic disorder, schizophrenia) or history of a non-mood psychotic disorder

If on a psychotropic medication regimen, that regimen will be stable for at least 4 weeks prior to randomization in the study and patient will be willing to remain on a stable regimen during the acute treatment phase

Known current bipolar I disorder as determined by SCID or a history of bipolar I disorder

Has an adequately stable condition and environment to enable attendance at scheduled clinic visits

Current amnestic disorders, dementia, Blessed Orientation-Memory-Concentration score > 10, delirium, or other cognitive disorders

For female participants, agrees to use one of the following acceptable methods of birth control

Current substance abuse (not including caffeine or nicotine) as determined by positive toxicology screen, or by history via SCID, within 3 months prior to screening

Able to read, verbalize understanding and voluntarily sign the Informed Consent Form prior to performance of any study-specific procedures or assessments

Patients with an elevated risk of seizure due to TBI

Participation in another concurrent clinical trial

Patients with prior exposure to rTMS

Active current suicidal intent or plan as evidenced by a score of 4 or 5 on the suicidal ideation portion of the Columbia Suicide Severity Rating Scale (CSSRS) or the endorsement of an actual attempt, interrupted attempt, or an aborted attempt in the past 6 months

Unstable cardiac disease or recent (<3 months previous) myocardial infarction

Patient refuses to sign consent for participation in the study