Key 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);
b. Individuals diagnosed by the investigator with the following conditions (current unless other-wise 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; Obsessive compulsive disorder (lifetime); or Post-traumatic
stress disorder (current or within the past year).
c. 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.
d. 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; Any
history of seizure EXCEPT those therapeutically induced by ECT; History of cerebrovascular accident;
Transient ischemic attack within two years; Cerebral aneurysm; Dementia; Mini Mental Status Exam
(MMS) score of <24; Parkinson#s disease; Huntington#s chorea; or Multiple sclerosis.
e. Increased risk of seizure for any reason, including 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;
f. A true positive response to any question on the Transcranial Magnetic Stimulation Adult Safety Screen
questionnaire (see Attachment H)
g. Lifetime treatment with more than 12 antidepressant medication trials, at any dose or duration, either
monotherapy or combination therapy from the list summarized in Attachment I.
h. ECT treatment within 3 months prior to the screening visit;
i. Failure to respond to ECT treatment (i.e., consistent with ATHF level 2 or higher) in this or any previous
j. History of treatment with rTMS therapy for any disorder;
k. History of treatment with Vagus Nerve Stimulation;
l. Use of any investigational drug within 4 weeks of the randomization visit;
m. Use of fluoxetine within 6 weeks of the randomization visit;
n. Use of an MAOI within 2 weeks of the randomization visit;
o. Use of any medication(s) listed on the Excluded Medication List (Attachment J) within 1 week of the
randomization visit;
p. Significant acute suicide risk, defined as follows: Suicide attempt within the previous 6 months that
required medical treatment; or >2 suicide attempts in the past 12 months; or Has a clear-cut plan for suicide
and states that he/she cannot guarantee that he/she will call his/her regular psychiatrist or the Investigator if
the impulse to implement the plan becomes substantial during the study; or in the investigator#s opinion, is
likely to attempt suicide within the next 6 months.
q. Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease;
r. 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;s. Known or
suspected pregnancy;
t. 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 rTMS trial;
u. Positive urine drug screen. (A positive urine drug screen at screening may be repeated once prior to
randomization);
v. Clinically significant laboratory abnormality, in the opinion of the investigator;
w. Women who are breast-feeding;
x. Women of child-bearing potential not using a medically accepted form of contraception when engaging
in sexual intercourse.