Efficacy and Safety Study of NeuroStar TMS Therapy in Patients With Major Depressive Disorder With Postpartum Onset
Efficacy and Safety Study of NeuroStar TMS Therapy in Patients With Major Depressive Disorder With Postpartum Onset
The purpose of this study is to evaluate the safety and effectiveness of acute NeuroStar TMS
 therapy in women who have postpartum depression.
Evaluate the antidepressant effectiveness of acute treatment with NeuroStar TMS Therapy in
 patients with MDD with postpartum onset.

 Determine the safety of NeuroStar TMS Therapy by assessment of any medically significant,
 device-related adverse events during acute treatment.

 Determine the Safety of NeuroStar TMS Therapy by assessment of maternal and infant
 interactions on standardized bonding questionnaires.
Inclusion Criteria:

 -  Female outpatients, 18 to 50 years of age.

 -  Diagnosis of DSM-IV defined Major Depressive Disorder, single or recurrent episode,
 with current episode duration of at least 2 weeks.

 -  Onset and duration of current illness within 6 months of live childbirth.

 -  HAMD17 total score of greater than or equal to 18 and a score on the Edinburgh
 Postnatal Depression scale (EPDS) greater than or equal to 10.

 -  Patient cannot be on an antidepressant or other psychotropic medications during the
 study.

 -  Capable and willing to provide informed consent.

 -  Signed HIPAA authorization.

 -  Able to adhere to the treatment schedule.

 Exclusion Criteria:

 -  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).

 -  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.

 -  History of treatment with Vagus Nerve Stimulation.

 -  History of failure to respond to an adequate course of ECT treatment.

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

 -  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.

 -  Women of child-bearing potential not using a medically accepted form of contraception
 when engaging in sexual intercourse.