A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Nexalin Electrical Brain Stimulation for the Treatment of Depression in Patients Referred to Electro-Convulsive Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Treatment Response
研究概览
简要总结
The purpose of this research study is to determine whether Nexalin Trans-Cranial Electrical Stimulation (TES) is an effective treatment for depression among patients who are candidates for ECT. A secondary aim to assess whether Nexalin can be used as an alternative to ECT. Although Nexalin has been approved for use in the US, using Nexalin to treat depression in this way is investigational and experimental. If Nexalin is found to be an alternative to ECT, it could offer a safer treatment for depression with less side-effects and a lower cost.
!!! NOTE !!! Post Script / Post Study. The ECT arm (profiling subjects as ECT accepters vs. rejecters) was dropped owing to site objections by referring clinicians. Accordingly, the study was framed as a simple comparison between TES and SHAM TES.
详细描述
A 2x2 factor Randomized Controlled Trial with block randomization. Inpatient subjects at the Carrier Clinic who are referred for ECT will be recruited, typed regarding their acceptance of ECT, and randomized to either treatment with TES or to a Sham condition. Treatment non-responders in either condition will continue as in patients at the Carrier Clinic until they reach acceptable levels of functioning to be discharged.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All participants and investigators are blind to condition.
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
- •In-patients at the Carrier Clinic
- •Adults over age 18 and under age 65
- •Able to speak, read and write fluently in English, assessed by the study coordinator at Carrier Clinic
- •Screened Negative for alcohol abuse and/or dependence
- •Able to provide informed consent, assessed by the study coordinator at Carrier Clinic
- •Referred for ECT
- •Not currently taking hypnotics or be prescribed hypnotics during the Nexalin trial
- •Not pregnant or intending to become pregnant during the study
- •Committed to completion of the study
排除标准
- •Medically or psychiatrically unstable, where the severity of the illness prohibits the subject from engaging in study procedures.
研究组 & 干预措施
Accept ECT - TES
Accept ECT where subject is randomized to TES
干预措施: Nexalin Based Trans-Cranial Electrical Stimulation (Device)
Accept ECT - SHAM
Accept ECT where subject is randomized to a SHAM condition
干预措施: Nexalin Based Trans-Cranial Electrical Stimulation (Device)
Reject ECT - TES
Reject ECT where subject is randomized to TES
干预措施: Nexalin Based Trans-Cranial Electrical Stimulation (Device)
Reject ECT - SHAM
Reject ECT where subject is randomized to SHAM
干预措施: Nexalin Based Trans-Cranial Electrical Stimulation (Device)
结局指标
主要结局
Treatment Response
时间窗: 1-2 weeks
Percent responders to TES treatment and Sham TES (50% reduction or a score below 10 on the PHQ-9). The PHQ-9 is a 9 item scale, where each item ranges from 0 to 3. Zero represents "not at all" and 3 represents "nearly every day". The scale ranges from 0-27. We used percent change (from admission to "ex-take") as a our metric.
次要结局
未报告次要终点