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临床试验/NCT00774813
NCT00774813已完成2 期

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

Kalaco Scientific, Inc.2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2007年10月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
120
试验地点
2
主要终点
Hamilton Depression Rating Scale (HAM-D21)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

详细描述

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)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 65 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

A

Active Comparator

Nexalin 1.3mA device + placebo antidepressant

干预措施: Nexalin 1.3mA Device (Device)

B

Active Comparator

Nexalin 15mA device + placebo antidepressant

干预措施: Nexalin 15mA device (Device)

C

Placebo Comparator

Placebo device + SSRI (Citalopram or similar)

干预措施: placebo device and Citalopram (Drug)

结局指标

主要结局

Hamilton Depression Rating Scale (HAM-D21)

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

次要结局

  • 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)

研究者

申办方类型
Industry

研究点 (2)

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