Nexalin Therapy for the Treatment of Depressive Symptoms

Phase 2

Completed

• Conditions: Depression
• Interventions: Device: Nexalin 1.3mA Device; Device: Nexalin 15mA device; Drug: placebo device and Citalopram

• Registration Number: NCT00774813
• Lead Sponsor: Kalaco Scientific, Inc.

Brief 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.

Detailed Description

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)

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Study First Submitted: 2008-07-03
• Status Verified: 2008-10
• Study First Submitted QC: 2008-10-16
• Last Update Submitted: 2008-10-16
• Study First Posted: 2008-10-17
• Last Update Posted: 2008-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Nexalin 1.3mA Device	Nexalin 1.3mA device + placebo antidepressant
B	Nexalin 15mA device	Nexalin 15mA device + placebo antidepressant
C	placebo device and Citalopram	Placebo device + SSRI (Citalopram or similar)

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale (HAM-D21)	Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12

Secondary Outcome Measures

Name	Time	Method
Adverse Event Log	Every visit
Beck's Depression Inventory	Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12
Clinical Global Impression (CGI)	Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12
Montgomery-Asberg Depression Rating Scale (MADRS)	Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12
Hamilton Anxiety Rating Scale (HAM-A)	Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12
Hospital Anxiety and Depression Scale (HADS)	Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12
Medication Usage Log	Every visit

Trial Locations

Locations (2)

Leningrad Regional Center of Addiction; 🇷🇺 Leningrad, Vsevolozhsky District, Russian Federation

St. Petersburg City Center of Neuroses; 🇷🇺 St. Petersburg, Russian Federation