Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents

Inclusion Criteria:

• Primary diagnosis of unipolar major depressive disorder, in a current major depressiveepisode, without psychotic features

• Duration of current episode of depression ≥4 weeks and ≤3 years

• Clinical Global Impression - Severity of Illness ≥ 4

• Resistance to antidepressant treatment in a discrete illness episode

• HAMD24 Item 1 ≥ 2 and total score ≥ 20

• Subjects able to commit to protocol visit schedule

• At the end of the baseline visit, subject must have a HAMD24 score of ≥ 18 and changein score may not be ≥ 25% decrease from that seen at the screening visit

Exclusion Criteria:

• Prior TMS, vagus nerve stimulation (VNS), or electroconvulsive therapy (ECT)

• Contraindication to TMS

• Cardiac pacemakers, implanted medication pumps, intracardiac lines

• History of neurological disorder

• Unstable medical conditions

• Any psychiatric disorder, which in the judgement of the Investigator may hinder thesubject in completing the procedures required by the study protocol.

• Significant acute suicide risk

• Inability to locate and quantify a motor threshold

• If sexually active female, not on an accepted method of birth control.

• Diagnoses of the following conditions (current unless otherwise stated):

• Depression secondary to a general medical condition, or substance induced:

• Seasonal pattern of depression as defined by Diagnostic and Statistical Manual ofMental Disorders (DSM-5)

• Any psychotic disorder (lifetime), including history of schizophrenia,schizoaffective disorder, other psychosis, psychotic features in this or previousepisodes, amnestic disorder,

• Intellectually disabled,

• Substance dependence or abuse within the past year (except nicotine or caffeine),

• Bipolar disorder,

• Obsessive compulsive disorder (lifetime),

• Post-traumatic stress disorder (lifetime),

• Eating disorder (lifetime).