Nexalin Therapy for the Treatment of Depressive Symptoms

Kalaco Scientific

Status and phase: Completed; Phase 2

Conditions: Depression

Treatments: Device: Nexalin 1.3mA Device; Device: Nexalin 15mA device; Drug: placebo device and Citalopram

Study type: Interventional

Funder types: Industry

Identifiers

NCT00774813

CPMS-7003

Details and patient eligibility

About

The primary objectives of this Phase II study are to demonstrate the safety of Nexalin Therapy and to investigate the efficacy of Nexalin Therapy.

Full 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)

Enrollment: 120 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 3 patient groups, including a placebo group

A

Active Comparator group

Description:

Nexalin 1.3mA device + placebo antidepressant

Treatment:

Device: Nexalin 1.3mA Device

B

Active Comparator group

Description:

Nexalin 15mA device + placebo antidepressant

Treatment:

Device: Nexalin 15mA device

C

Placebo Comparator group

Description:

Placebo device + SSRI (Citalopram or similar)

Treatment:

Drug: placebo device and Citalopram