Canadian rTMS Treatment and Biomarker Network in Depression Trial

Exclusion Criteria

• •1. have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of substance dependence or abuse within the last 3 months
• •2. have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
• •3. have active suicidal intent
• •4. are pregnant
• •5. have a lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms
• •6. have a MINI 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), or dysthymia, assessed by a study investigator to be primary and causing greater impairment than MDD
• •7. have a diagnosis of any personality disorder, and assessed by a study investigator to be primary and causing greater impairment than MDD
• •8. have failed a course of ECT in the current episode or previous episode
• •9. have received rTMS for any previous indication due to the potential compromise of subject blinding
• •10. have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except those therapeutically induced by ECT or a febrile seizure of infancy, cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, significant head trauma with loss of consciousness for greater than 5 minutes
• •11. have an intracranial implant (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
• •12. 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
• •13. clinically significant laboratory abnormality, in the opinion of the one of the principal investigators or study physicians
• •14. currently take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy
• •15. non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).