Nexalin Therapy for the Treatment of Depressive Symptoms

Study Overview
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Brief Summary
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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
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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)

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

Conditions
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Depression

Intervention / Treatment
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* Device: Nexalin 1.3mA Device
* Device: Nexalin 15mA device
* Drug: placebo device and Citalopram


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Nexalin 1.3mA device + placebo antidepressant | Device: Nexalin 1.3mA Device<br>* 3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off) Daily receipt of placebo antidepressant<br>* Other names: Nexalin Device;|
| Active Comparator: B<br>Nexalin 15mA device + placebo antidepressant | Device: Nexalin 15mA device<br>* 3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off) Daily receipt of a placebo antidepressant<br>* Other names: Nexalin Device;|
| Placebo Comparator: C<br>Placebo device + SSRI (Citalopram or similar) | Drug: placebo device and Citalopram<br>* 3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off) Daily receipt of a a SSRI (Citalopram or similar)<br>* Other names: Nexalin Device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Mild, Moderate, Anxiety, Kalaco Scientific, Inc.