The primary objectives of this Phase II study are to demonstrate the safety of Nexalin Therapy and to investigate the efficacy of Nexalin Therapy.

This randomized, double-blind, placebo-controlled, multi-center trial has 3 different treatment arms.

Study Tools:

• Hamilton Depression Rating Scale (HAM-D21)
• Clinical Global Impressions (CGI)
• Montgomery-Asberg Depression Rating Scale (MADRS)
• Beck's Depression Inventory
• Hamilton Anxiety Rating Scale (HAM-A)
• Hospital Anxiety and Depression Scale (HADS)

Inclusion Criteria:

• Diagnosed with mild to moderate depression episode, based on the HAM-D21 Rating Scale (10-13 = mild; 14-17 = mild to moderate)
• Diagnosed with mild to moderate depression episode based on ICD-10 Diagnostic Guidelines
• Is willing and able to spend 4 weeks as a hospital inpatient
• Is willing and able to return to the clinic during follow-up period

Exclusion Criteria:

• A HAM-D21 Rating Scale of <10 or >17
• Diagnosed outside of mild to moderate depression episode range based on the ICD-10 Diagnostic Guidelines
• Unable to complete wash-out interval without taking antidepressants or psychotropic medications
• Is pregnant or may be pregnant
• Sensitivity to electrodes and/or their conductive gels or adhesives
• Break in skin integrity at the areas of electrode placement
• Currently taking immune suppressing drugs or suspected use of narcotics
• Presence of any implanted electronic devices, cardiac stimulator, or pacemaker
• History of brain injury, including seizures, epilepsy, stroke, tumor of central nervous system, or hydrocephalus
• History of heart attacks, congestive heart failure, or uncontrolled hypertension
• History of schizophrenia or manic-depressive syndrome