iTBS Study for Depression (Randomized)

Exclusion Criteria

• •1. Inability to complete NIH tool box cognitive testing
• •2. Inability to provide informed consent
• •3. \<22 score on the Montreal Cognitive Assessment MoCA indicative of moderate to severe cognitive impairment per PI discretion
• •4. Lifetime diagnosis of bipolar I or II disorder or psychotic disorder as per the MINI interview
• •5. current psychotic symptoms
• •6. alcohol or other substance use disorder per DSM V criteria in the past 6 months
• •7. High risk for suicide (active suicidal ideation/intent or plan and patient is unsafe to be in the outpatient setting), an urgent psychiatric referral will be made in those cases
• •8. Have a diagnosis of obsessive compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), assessed by a study investigator to be primary
• •9. Previous history of TMS
• •10. history of failure to an adequate course of electroconvulsive therapy (ECT) such as equal or more than 7-9 electroconvulsive therapy treatments, per PI discretion
• •11. Major unstable medical illness including advanced/uncontrolled diabetes, hypertension, renal disease or advanced cancer, per PI discretion
• •12. Psychotropic use other than antidepressants (e.g., Benzodiazepines \[more than 2mg of lorazepam equivalent daily\], anticonvulsants \[except low dose of Neurontin approximately 600mg/day\] or cognitive enhancers such as N-Methyl D - Aspartate (NDMA) receptor antagonists \[Memantine HCL\], psychostimulants \[such as methylphenidate or modafinil\]) per PI discretion
• •13. Recent changes or initiation of antidepressant therapy approximately in the last 4 weeks prior to intervention delivery, per PI discretion
• •14. if participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study
• •15. contraindications for TMS including the presence of metallic objects within 30 cm of the TMS coil, intracranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed; presence of intracardiac lines, defibrillators or a cardiac pacemaker and unable to assess safety; presence of implanted electronic devices that control physiologic functions and unable to assess safety
• •16. have a personal history of a primary seizure disorder or a seizure associated with an intracranial lesion
• •17. History of severe head trauma or neurological disorders that substantially increase seizure risk, per PI discretion
• •18. non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).