PEMF Treatment in Patients With Treatment Resistant Depression in On-going Antidepressant Drug Therapy. A Randomized, Double-blind, Clinically Controlled, Dose-response PEMF Trial for a Duration of Eight Weeks
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Hamilton depression rating scale
研究概览
简要总结
In this study patients with treatment resistant depression, as defined by Harold Sackeim, is subjected to daily sessions, for eight weeks, with Pulsating ElectroMagnetive Treatment (PEMF). Treatment is given two times a day, in the morning and in the afternoon. Patients are randomized into two groups. In group A patients receive active treatment both morning and afternoon. In group B patients receive one sham and one active treatment. The study is double-blind as neither the assessors or patients are aware of treatment allocation. Each session lasts 30 minutes. Patients are psychometrically assessed weekly for depression severity and side effect. After this intervention period patients are followed for further three weeks without PEMF treatment. Patients are on unchanged medication for the whole of the study period.
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)
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment resistant Major depression (grade 3 Sackeim criteria)
- •Age above 18 and below 85
- •Hamilton (17 item version) score above 12
- •Unchanged psychopharmacological treatment for last five weeks.
排除标准
- •suicidality above 2 on item three on Hamilton scale or,earlier PEMF treatment
- •dementia or similar cognitive impairment
- •psychotic disorder
- •abuse of alcohol or drugs
- •pregnant or lactating women
- •insufficient birth control measures
结局指标
主要结局
Hamilton depression rating scale
时间窗: Every week for 11 weeks
Interviewer based rating scale to measure severity of depression
次要结局
- UKU(Every week for 11 weeks)
研究者
Per Bech
Professor
Hillerod Hospital, Denmark
