Clinical trial NCT00774813: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depression
Keywords: Depression
Mild
Moderate
Anxiety
Kalaco Scientific, Inc.
Lead sponsor: Kalaco Scientific, Inc.
Sponsor class: INDUSTRY
First posted: 2008-10-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: Hamilton Depression Rating Scale (HAM-D21)
timeFrame: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12
Secondary outcomes:
measure: Clinical Global Impression (CGI)
timeFrame: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12
measure: Beck's Depression Inventory
timeFrame: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12
measure: Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12
measure: Medication Usage Log
timeFrame: Every visit
measure: Adverse Event Log
timeFrame: Every visit
Other outcomes:
Locations:
city: Leningrad
country: Russian Federation
facility: Leningrad Regional Center of Addiction
state: Vsevolozhsky District
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg City Center of Neuroses
Study officials:
affiliation: Leningrad Regional Center of Addiction
name: Evgeny Kruptisky, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: