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Clinical Trials/NCT00774813
NCT00774813CompletedPhase 2

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

Kalaco Scientific, Inc.2 sites in 1 country120 target enrollmentStarted: October 2007Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
120
Locations
2
Primary Endpoint
Hamilton Depression Rating Scale (HAM-D21)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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)

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

A

Active Comparator

Nexalin 1.3mA device + placebo antidepressant

Intervention: Nexalin 1.3mA Device (Device)

B

Active Comparator

Nexalin 15mA device + placebo antidepressant

Intervention: Nexalin 15mA device (Device)

C

Placebo Comparator

Placebo device + SSRI (Citalopram or similar)

Intervention: placebo device and Citalopram (Drug)

Outcomes

Primary Outcomes

Hamilton Depression Rating Scale (HAM-D21)

Time Frame: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12

Secondary Outcomes

  • Adverse Event Log(Every visit)
  • Beck's Depression Inventory(Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12)
  • Clinical Global Impression (CGI)(Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12)
  • Montgomery-Asberg Depression Rating Scale (MADRS)(Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12)
  • Hamilton Anxiety Rating Scale (HAM-A)(Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12)
  • Hospital Anxiety and Depression Scale (HADS)(Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12)
  • Medication Usage Log(Every visit)

Investigators

Sponsor Class
Industry

Study Sites (2)

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