Comparative Effectiveness Research Trial for Antidepressant Incomplete and Non-responders With TRD

You may not qualify if:

• pregnant or breastfeeding women, women of childbearing potential who are not using an accepted means of birth control, or women with a positive urine pregnancy test,
• patients who have received treatment with rTMS, aripiprazole, electroconvulsive therapy (ECT), or venlafaxine during the current episode,
• patients who express an objection to receiving treatment with at least one of the three treatment arms of our study,
• patients with any history of bipolar disorder or psychosis (diagnosed by MINI),
• patients with active alcohol or substance abuse disorders within the past 6 months (diagnosed by MINI),
• patients with suicidal ideation of the degree that, in the opinion of the evaluating clinician, participation in the study would place them at significantly increased risk of suicide,
• patients with unstable medical issues of such degree that, in the opinion of the evaluating clinician, participation in the study would place them at significant risk of a serious adverse event, or patients with a screening hemoglobin A1c level greater than 7.5%, or patients with epilepsy, dementia, Parkinson's disease, or Huntington's Disease,
• patients who have received treatment with vagus nerve stimulation (VNS),
• patients who have not responded to more than five FDA-approved antidepressant treatment trials of adequate dose and duration during the current episode, or who did not respond to ECT in previous episodes
• patients on excluded medications,
• patients with a positive urine screen drug test for a substance for which they do not have a valid prescription for a valid medical reason,
• patients with currently abnormal thyroid function tests,
• patients who have received at least one dose of a monoamine oxidase inhibitor (MAOI) four weeks or less prior, and
• for patients on concomitant psychotropic agents (anticonvulsants, benzodiazepines, hypnotics, opiates, triiodothyronine (T3), modafinil, psychostimulants, buspirone, melatonin, omega-3 fatty acids, folate, l-methylfolate, s-adenosyl methionine, lithium) not on the same dose for at least four weeks prior to study entry or who do not agree to continue at the same dose during the acute phase of the study.
• Patients who do not meet safety criteria for TMS: history of seizures, cardiac pacemaker, DBS or VNS, brain aneurism clips or other metallic implants in the intracranial space.
• +1 more criteria