Depression
Conditions
Keywords
Depression, Mild, Moderate, Anxiety, Kalaco Scientific, Inc.
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)
Interventions
DEVICENexalin 1.3mA Device
* 3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off) * Daily receipt of placebo antidepressant
DEVICENexalin 15mA device
* 3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off) * Daily receipt of a placebo antidepressant
DRUGplacebo 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)
Sponsors
Kalaco Scientific, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale (HAM-D21) | Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Clinical Global Impression (CGI) | Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12 |
| Medication Usage Log | Every visit |
| Adverse Event Log | Every visit |
| Hospital Anxiety and Depression Scale (HADS) | Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12 |
Countries
Russia
Outcome results
None listed