Evaluation of the Brainsway Deep Transcranial Magnetic Stimulation (TMS) H-Coil in the Treatment of Major Depression Disorder

Inclusion Criteria:

• Outpatients.

• Men and women 22-68 years of age.

• Primary DSM-IV diagnosis of Major Depression, single or recurrent episode.

• Current depressive episode is less than 5 years duration.

• The patient did not respond to at least one but not more than four antidepressanttreatments in the current episode.

• Patients who have not completed antidepressant trials due to intolerance to therapy of 2 or more anti-depressant medications in the current episode.

• Satisfactory safety screening questionnaire for transcranial magnetic stimulation.

• Patients not suffering from hypo or hyper-thyroidism based on pre-study TSH level ormedically stabilized.

• Patients able to tolerate psychotropic medication washout and no psychotropics duringthe treatment, other than benzodiazepine at equivalent daily dose of up to 3 mglorazepam.

Exclusion Criteria:

• A history of schizophrenia, any psychotic disorder, PTSD, bipolar disorder, OCD,eating disorders (e.g., anorexia nervosa, bulimia) or substance abuse

• A history of panic disorder, social anxiety disorder or personality disorder (such asantisocial, schizotypal, histrionic, borderline, narcissistic) as assessed by theinvestigator to be primary, causing a higher degree of distress or impairment thanMDD.

• A history of any significant medical disease (i.e., cardiovascular, gastrointestinal,etc.)

• A history of seizures, at risk for seizure (e.g., history of significant head traumawith loss of consciousness for greater than or equal to 5 minutes or familial orpersonal history of epilepsy) or have been diagnosed with a seizure disorder.

• Undergone rTMS treatment, Vagus Nerve Stimulation, or Deep Brain Stimulation.

• Received ECT within the last 3 months or failed to respond to ECT treatment.

• Individuals with a significant neurological disorder or insult including:

• 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

• Parkinson's disease

• Huntington's chorea

• Multiple sclerosis

• Individuals with hearing loss.

• Any intracranial implant such as aneurysm clips, shunts, stimulators, cochlearimplants, or electrodes, or any other metal object within or near the head, excludingthe mouth, that cannot be safely removed.

• A cardiac pacemaker, implanted medication pump, intracardiac line, or acute, unstablecardiac disease.

• Use of fluoxetine within 6 weeks of the randomization visit.

• Use of a Monoamine Oxidase Inhibitor (MAOI) within 2 weeks of the randomization visit.

• Present suicidal risk as assessed by the investigator.

• Implanted neurostimulators.

• History of abnormal MRI.

• If participating in psychotherapy, must have been in stable treatment for at least 3months prior to entry into the study, with no anticipation of change in the frequencyof therapeutic sessions, or the therapeutic focus over the duration of the rTMS trial.

• Clinically significant laboratory abnormality, in the opinion of the Investigatorbased on CBC and biochemistry.

• Women of childbearing potential and not using a medically accepted form ofcontraception when engaging in sexual intercourse.

• Women: if pregnant, planning on becoming pregnant, or currently nursing.