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Nexalin Therapy for the Treatment of Depressive Symptoms

Primary Purpose

Depression

Status

Completed

Phase

Phase 2

Locations

Russian Federation

Study Type

Interventional

Intervention

Nexalin 1.3mA Device

Nexalin 15mA device

placebo device and Citalopram

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Mild, Moderate, Anxiety, Kalaco Scientific, Inc.

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Leningrad Regional Center of Addiction
St. Petersburg City Center of Neuroses

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Nexalin 1.3mA device + placebo antidepressant

Nexalin 15mA device + placebo antidepressant

Placebo device + SSRI (Citalopram or similar)

Outcomes

Primary Outcome Measures

Hamilton Depression Rating Scale (HAM-D21)

Secondary Outcome Measures

Clinical Global Impression (CGI)

Montgomery-Asberg Depression Rating Scale (MADRS)

Beck's Depression Inventory

Hamilton Anxiety Rating Scale (HAM-A)

Hospital Anxiety and Depression Scale (HADS)

Medication Usage Log

Adverse Event Log

Full Information

NCT ID

NCT00774813

First Posted

July 3, 2008

Last Updated

October 16, 2008

Sponsor

Kalaco Scientific, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00774813

Brief Title

Nexalin Therapy for the Treatment of Depressive Symptoms

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2008

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Kalaco Scientific, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

Keywords

Depression, Mild, Moderate, Anxiety, Kalaco Scientific, Inc.

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Nexalin 1.3mA device + placebo antidepressant

Arm Title

Arm Type

Active Comparator

Arm Description

Nexalin 15mA device + placebo antidepressant

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo device + SSRI (Citalopram or similar)

Intervention Type

Device

Intervention Name(s)

Nexalin 1.3mA Device

Other Intervention Name(s)

Nexalin Device

Intervention Description

3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off) Daily receipt of placebo antidepressant

Intervention Type

Device

Intervention Name(s)

Nexalin 15mA device

Other Intervention Name(s)

Nexalin Device

Intervention Description

3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off) Daily receipt of a placebo antidepressant

Intervention Type

Drug

Intervention Name(s)

placebo device and Citalopram

Other Intervention Name(s)

Nexalin Device

Intervention Description

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

Primary Outcome Measure Information:

Title

Hamilton Depression Rating Scale (HAM-D21)

Time Frame