Trial | NCT00774813  Report issue

Title

Nexalin Therapy for the Treatment of Depressive Symptoms
Phase II Study Using Nexalin Therapy for the Treatment of Depressive Symptoms Associated With Mild to Moderate Depression Episodes

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    citalopram ...

  • Study Participants

    120
The primary objectives of this Phase II study are to demonstrate the safety of Nexalin Therapy and to investigate the efficacy of Nexalin Therapy.
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)
Study Started
Oct 31
2007
Primary Completion
May 31
2008
Study Completion
May 31
2008
Last Update
Oct 17
2008
Estimate

Device Nexalin 1.3mA Device

3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off) Daily receipt of placebo antidepressant

  • Other names: Nexalin Device

Device Nexalin 15mA device

3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off) Daily receipt of a placebo antidepressant

  • Other names: Nexalin Device

Drug 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 names: Nexalin Device

A Active Comparator

Nexalin 1.3mA device + placebo antidepressant

B Active Comparator

Nexalin 15mA device + placebo antidepressant

C Placebo Comparator

Placebo device + SSRI (Citalopram or similar)

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
No Results Posted