Nexalin Therapy for the Treatment of Depressive Symptoms

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kalaco Scientific, Inc.
• Treatments: Antidepressive Agents; Citalopram; Dexetimide

Criteria

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