Nexalin Therapy for the Treatment of Depressive Symptoms

Phase II Study Using Nexalin Therapy for the Treatment of Depressive Symptoms Associated With Mild to Moderate Depression Episodes

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