Nexalin Therapy for the Treatment of Depressive Symptoms

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00774813
• Other study ID #: CPMS-7003
• Status: Completed
• Phase: Phase 2
• First received: July 3, 2008
• Last updated: October 16, 2008
• Start date: October 2007
• Est. completion date: May 2008

Study information

• Verified date: October 2008
• Source: Kalaco Scientific, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Device:
• Nexalin 1.3mA Device
3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off) Daily receipt of placebo antidepressant
• Nexalin 15mA device
3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off) Daily receipt of a placebo antidepressant

Drug:
• placebo device and Citalopram
3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off) Daily receipt of a a SSRI (Citalopram or similar)

Locations

Country	Name	City	State
Russian Federation	Leningrad Regional Center of Addiction	Leningrad	Vsevolozhsky District
Russian Federation	St. Petersburg City Center of Neuroses	St. Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Kalaco Scientific, Inc.

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale (HAM-D21)		Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12	No
Secondary	Clinical Global Impression (CGI)		Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12	No
Secondary	Montgomery-Asberg Depression Rating Scale (MADRS)		Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12	No
Secondary	Beck's Depression Inventory		Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12	No
Secondary	Hamilton Anxiety Rating Scale (HAM-A)		Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12	No
Secondary	Hospital Anxiety and Depression Scale (HADS)		Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12	No
Secondary	Medication Usage Log		Every visit	No
Secondary	Adverse Event Log		Every visit	Yes