Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression

Prior treatment

• have a concomitant major unstable medical illness;
• 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;
• require a benzodiazepine with a dose \> lorazepam 2 mg/day or equivalent or any anticonvulsant due to the potential of these medications to limit the efficacy of both MST and ECT;

Other illness

• have a history of MINI diagnosis of substance dependence or abuse within the past three months;
• have a MINI diagnosis of any primary psychotic disorder
• have a MINI diagnosis of obsessive compulsive disorder, or post-traumatic stress disorder deemed to be primary and causing more functional impairment than the depressive disorder
• have probable dementia based on study investigator assessment;
• have any significant neurological disorder or condition likely to be associated with increased intracranial pressure or a space occupying brain lesion, e.g., cerebral aneurysm;
• have a non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests).

Lab values

• present with a medical condition, a medication, or a laboratory abnormality that could cause a major depressive episode or significant cognitive impairment in the opinion of the investigator (e.g., hypothyroidism with low TSH, rheumatoid arthritis requiring high dose prednisone, or Cushing's disease);

Other

• Patients will be excluded if they:
• are pregnant or intend to get pregnant during the study;
• are unable to communicate in English fluently enough to complete the neuropsychological tests;

• Patients will be included if they:
• are inpatients or outpatients;
• are voluntary and competent to consent to treatment and research procedures according to ECT/MST attending psychiatrist;
• have a MINI International Neuropsychiatric Interview diagnosis, Version 6 (MINI-6.0) diagnosis of non-psychotic MDD
• are 18 years of age or older
• have a baseline HRSD-24 score \> or = 21;
• are considered to be appropriate to receive convulsive therapy as assessed by an ECT attending psychiatrist and a consultant anaesthesiologist
• are agreeable to keeping their current antidepressant treatment constant during the intervention;
• are likely able to adhere to the intervention schedule;
• meet the MST safety criteria \[75\];
• If a woman of child-bearing potential: is willing to provide a negative pregnancy test and agrees not to become pregnant during trial participation.