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
Lead SponsorKalaco Scientific, Inc.
StatusCompleted No Results Posted
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.
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)
3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off) Daily receipt of placebo antidepressant
3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off) Daily receipt of a placebo antidepressant
3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off) Daily receipt of a a SSRI (Citalopram or similar)
Nexalin 1.3mA device + placebo antidepressant
Nexalin 15mA device + placebo antidepressant
Placebo device + SSRI (Citalopram or similar)
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