Pulsed Electro Magnetic Fields (PEMF) Treatment in Patients With Treatment-Resistant Major Depression in Ongoing Pharmacological Treatment of Depression
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Hamilton Depression Rating Scale score (depression)
研究概览
简要总结
About 30% of patients with major depression are treatment resistant to pharmacological treatment. In the search for new methods to treat depression a great interest has been put into the use of electromagnetic fields. This study tests the hypothesis that ultra-weak electromagnetic fields with a specific wave pattern (PEMF = pulsed electro magnetic fields) can alleviate the symptoms of depression.
详细描述
In this study, a patient with treatment resistant depression, as defined by Harold Sackeim, is subjected to 5 weeks of treatment with active or sham PEMF treatment for 30 minutes on every working day. The pharmacological treatment for depression is maintained unaltered throughout the study. Depression severity is measured at the beginning of the study and at each weekly visit. Side effects are closely observed. The ability to concentrate is measured by the AQT test (Alzheimers Quick Test). Personality is assessed by use of the SCID-II-instrument (DSM-IV axis II).
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major depression
- •Treatment resistance
- •Age above 18 years
- •Hamilton 17 item score above 13
- •Unaltered pharmacological treatment in last 4 weeks
排除标准
- •Psychotic disorder
- •Mental retardation
- •Suicidality
- •Earlier treatment with PEMF
- •Abuse of alcohol or other substances
- •Patient not able to come to appointed visits
- •Antisocial, borderline or schizotypic personality disorder
- •Women lactating or pregnant
- •Unreliable contraception
结局指标
主要结局
Hamilton Depression Rating Scale score (depression)
时间窗: 1 week
次要结局
- AQT, measure of concentration(weekly)