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

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

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Device: Nexalin 1.3mA Device; Device: Nexalin 15mA device; Drug: placebo device and Citalopram

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• Russian Federation
  • St. Petersburg, Russian Federation, 191187
    • St. Petersburg City Center of Neuroses
  • Vsevolozhsky District
    • Leningrad, Vsevolozhsky District, Russian Federation, 188661
      • Leningrad Regional Center of Addiction

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: A; Nexalin 1.3mA device + placebo antidepressant	Device: Nexalin 1.3mA Device; 3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off); Daily receipt of placebo antidepressant; Other Names: Nexalin Device
ACTIVE_COMPARATOR: B; Nexalin 15mA device + placebo antidepressant	Device: Nexalin 15mA device; 3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off); Daily receipt of a placebo antidepressant; Other Names: Nexalin Device
PLACEBO_COMPARATOR: C; Placebo device + SSRI (Citalopram or similar)	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); Other Names: Nexalin Device

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Beck's Depression Inventory	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
Adverse Event Log	Every visit

Collaborators and Investigators

• Sponsor: Kalaco Scientific, Inc.
• Investigators: Principal Investigator: Evgeny Kruptisky, MD, PhD, Leningrad Regional Center of Addiction

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (ACTUAL): May 1, 2008
• Study Completion (ACTUAL): May 1, 2008

Study Registration Dates

• First Submitted: July 3, 2008
• First Submitted That Met QC Criteria: October 16, 2008
• First Posted (ESTIMATE): October 17, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): October 17, 2008
• Last Update Submitted That Met QC Criteria: October 16, 2008
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Moderate; Mild; Kalaco Scientific, Inc.
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Citalopram
• Other Study ID Numbers: CPMS-7003