Repetitive Transcranial Magnetic Stimulation Trajectory of Outcomes Study

Repetitive Transcranial Magnetic Stimulation Trajectory of Outcomes Study in Major Depression

This prospective, single-arm, open-label feasibility study will assess the safety, tolerability, and effectiveness of repetitive transcranial magnetic stimulation (rTMS) in patients with major depression (MDD) to test the hypothesis that remission rates can be increased by additional treatment sessions.

Inclusion Criteria:

• are outpatients
• are voluntary and competent to consent to treatment
• are between the ages of 18 and 85, inclusive
• are able to adhere to the treatment schedule
• pass the TMS safety-screening questionnaire
• have had no change or initiation of any psychotropic medication in the 4 weeks prior to screening

Exclusion Criteria:

• previous rTMS treatment
• have a history of substance dependence or abuse within the last 3 months
• have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
• have active suicidal intent
• have a diagnosis of any personality disorder, and assessed by a study investigator to be primary and causing greater impairment than MDD
• have a diagnosis of any psychotic disorder
• 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 confirmed diagnostically by neurological assessment (except those therapeutically induced by ECT), cerebral aneurysm, Parkinson's disease, Huntington's chorea, dementia, stroke, neurologically confirmed diagnosis of traumatic brain injury, or multiple sclerosis.
• 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
• clinically significant laboratory abnormality, in the opinion of the investigator
• currently (or in the last 4 weeks) take more than lorazepam 4 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy
• non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview)
• any significant cardiovascular or metabolic disorder or insult including, but not limited to: coronary artery disease, abnormal heart rhythms, heart failure, cardiac valve disease, congenital heart disease, cardiomyopathy, vascular disease, dyslipidemia, diabetes, or hypertension