Status:
COMPLETED
Nexalin Therapy for the Treatment of Depressive Symptoms
Lead Sponsor:
Kalaco Scientific, Inc.
Conditions:
Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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) * ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00774813
Start Date
October 1 2007
End Date
May 1 2008
Last Update
October 17 2008
Active Locations (2)
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1
Leningrad Regional Center of Addiction
Saint Petersburg, Vsevolozhsky District, Russia, 188661
2
St. Petersburg City Center of Neuroses
Saint Petersburg, Russia, 191187