Nexalin Therapy for the Treatment of Depressive Symptoms
NCT ID: NCT00774813
Last Updated: 2008-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
120 participants
INTERVENTIONAL
2007-10-31
2008-05-31
Brief Summary
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Detailed Description
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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)
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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A
Nexalin 1.3mA device + placebo antidepressant
Nexalin 1.3mA Device
* 3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off)
* Daily receipt of placebo antidepressant
B
Nexalin 15mA device + placebo antidepressant
Nexalin 15mA device
* 3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off)
* Daily receipt of a placebo antidepressant
C
Placebo device + SSRI (Citalopram or similar)
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)
Interventions
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Nexalin 1.3mA Device
* 3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off)
* Daily receipt of placebo antidepressant
Nexalin 15mA device
* 3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off)
* Daily receipt of a placebo antidepressant
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Kalaco Scientific, Inc.
INDUSTRY
Responsible Party
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Leningrad Regional Center of Addiction
Principal Investigators
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Evgeny Kruptisky, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Leningrad Regional Center of Addiction
Locations
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Leningrad Regional Center of Addiction
Saint Petersburg, Vsevolozhsky District, Russia
St. Petersburg City Center of Neuroses
Saint Petersburg, , Russia
Countries
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Other Identifiers
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CPMS-7003
Identifier Type: -
Identifier Source: org_study_id