Skip to main content

Table 1 rTMS trial inclusion and exclusion criteria

From: Repetitive transcranial magnetic stimulation (rTMS) for treatment-resistant major depression (TRMD) Veteran patients: study protocol for a randomized controlled trial

Inclusion criteria 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Structured Clinical Interview for DSM Disorders (SCID) for DSM-IV-TR patients will be diagnosed MDD Unable to be safely withdrawn, at least 2 weeks prior to treatment commencement, from medications that substantially increase the risk of having seizures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
  1. SCID Structured Clinical Interview for DSM Disorders, MDD major depressive disorder, HRSD Hamilton Rating Scale for Depression, ATHF Antidepressant Treatment History Form, VA Veterans Affairs, FDA Food and Drug Administration, rTMS Repetitive transcranial magnetic stimulation, TBI traumatic brain injury