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
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Depression, Mild, Moderate, Anxiety, Kalaco Scientific, Inc.
Eligibility 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
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
Active Comparator
Placebo Comparator
Arm Label
A
B
C
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
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
No
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
A
Arm Type
Active Comparator
Arm Description
Nexalin 1.3mA device + placebo antidepressant
Arm Title
B
Arm Type
Active Comparator
Arm Description
Nexalin 15mA device + placebo antidepressant
Arm Title
C
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
Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12
Secondary Outcome Measure Information:
Title
Clinical Global Impression (CGI)
Time Frame
Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12
Title
Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame
Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12
Title
Beck's Depression Inventory
Time Frame
Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12
Title
Hamilton Anxiety Rating Scale (HAM-A)
Time Frame
Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12
Title
Hospital Anxiety and Depression Scale (HADS)
Time Frame
Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12
Title
Medication Usage Log
Time Frame
Every visit
Title
Adverse Event Log
Time Frame
Every visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evgeny Kruptisky, MD, PhD
Organizational Affiliation
Leningrad Regional Center of Addiction
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leningrad Regional Center of Addiction
City
Leningrad
State/Province
Vsevolozhsky District
ZIP/Postal Code
188661
Country
Russian Federation
Facility Name
St. Petersburg City Center of Neuroses
City
St. Petersburg
ZIP/Postal Code
191187
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
Nexalin Therapy for the Treatment of Depressive Symptoms
We'll reach out to this number within 24 hrs