Maintenance NeuroStar Transcranial Magnetic Stimulation (TMS) in Patients With Major Depressive Disorder

This is a 12-month maintenance treatment study for patients who have responded to a 6 week
course of acute TMS treatment for major depressive disorder (MDD). The study will seek to
assess the change in depressive symptomatology across the duration of maintenance treatment
using observer and self-administered efficacy measures. Describe the efficacy of TMS
re-introduction in patients not receiving maintenance pharmacotherapy who show a recurrence
of depressive symptoms. Assess the safety and durability of acute TMS therapy followed by
maintenance TMS treatment for up to 12 months.

Inclusion Criteria:

- Primary diagnosis by DSM-IV criteria for Major Depressive Episode, single episode or
recurrent course of illness, with the additional stipulation of a duration for this
episode of ≥ 4 weeks and CGI-S ≥ 4.

- Duration of current episode of depression ≤ 3 years (the definition of an episode is
demarcated by a period of ≥ 2 months when the patient did not meet full criteria for
the DSM-IV definition of Major Depressive Episode.

- Capable and willing to provide informed consent.

- Signed HIPAA authorization.

- Able to adhere with the treatment schedule, and withdrawal of ongoing
pharmacotherapy.

- If currently taking antidepressant pharmacotherapy, must be clinically appropriate to
discontinue treatment with those agents.

Exclusion Criteria:

- Investigators, site personnel directly affiliated with this study, and their
immediate families (immediate family is defined as a spouse, parent, child or
sibling, whether by birth or legal adoption).

- Individuals diagnosed by the Investigator with the following conditions (current
unless otherwise stated):

- Depression secondary to a general medical condition, or substance- induced;

- Seasonal pattern of depression as defined by DSM-IV;

- History of substance abuse or dependence within the past year except nicotine
and caffeine);

- Any psychotic disorder (lifetime), including schizoaffective disorder, or major
depression with psychotic features in this or previous episodes;

- Bipolar disorder;

- Eating disorder (current or within the past year);

- Obsessive compulsive disorder (lifetime); or

- Post-traumatic stress disorder (current or within the past year).

- An Axis II Personality Disorder, which in the judgment of the Investigator may hinder
the patient in completing the procedures required by the study protocol.

- Individuals with a clinically defined neurological disorder or insult including, but
not limited to:

- Any condition likely to be associated with increased intracranial pressure;

- Space occupying brain lesion;

- History of cerebrovascular accident;

- Transient ischemic attack within two years;

- Cerebral aneurysm;

- Dementia;

- Parkinson's disease;

- Huntington's chorea;

- Multiple sclerosis.

- Increased risk of seizure for any reason, including but not limited to prior
diagnosis of increased intracranial pressure (such as after large infarctions or
trauma), or history of significant head trauma with loss of consciousness for ≥ 5
minutes.

- History of treatment with Vagus Nerve Stimulation.

- Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute,
unstable cardiac disease.