Feasibility Study to Test Clinical Efficacy of Low Energy AC Magnetic Field to Treat Major Depression

• Change in Hamilton Depression Rating Scale (HAMD-17) at baseline and the end of Week 4 of treatment. [ Time Frame: Assessed at baseline and the end of Week 4 of treatment. ] [ Designated as safety issue: No ]
  Outcome measured using the Hamilton Depression Rating Scale (HAMD-17) and calculated as percent reduction in severity score from baseline until the end of the 4th week of treatment.
  
  

• Safety profile of the treatment [ Time Frame: Outcome assessed at the end of the 4th week of treatment. ] [ Designated as safety issue: Yes ]
  Describe the safety profile of the administration of low-emission sinusoidal magnetic fields above the subject's scalp. Safety criteria include adverse events, serious adverse events, and vital signs.
  
  

Major Depressive Disorder (MDD) is associated with functional impairment and disability, and results in a significant burden on the affected individual, his or her family, and society in general. Psychopharmacological therapy has been shown to be effective, but may be accompanied by significant side effects. The investigators propose an alternative model, based on the relationship between symptoms, brain metabolism, and neural activity as recorded with electroencephalography (EEG). Subjects with MDD often have decreased brain metabolism, accompanied by increased EEG activity in the alpha band. The investigators hypothesis is that a gentle, non-significant risk, sinusoidal magnetic field above the subject's scalp, which oscillates at precisely his or her Intrinsic Alpha Frequency (IAF) can take advantage of this relationship to reduce symptoms without the significant side effects associated with pharmaceuticals. The investigators propose a 4-week, sham controlled, randomized, double-blind multi-center feasibility study to determine the efficacy of synchronized low energy magnetic fields delivered at the subject's IAF to treat MDD. Treatment will be given concomitant to the subject's existing medication, and will occur 5 days per week at the clinical site. Target enrollment is 45 adult subjects diagnosed with MDD.