A Randomised Study of rTMS in Depression
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Depression Rating Scales
研究概览
简要总结
This study will report on the outcomes of rTMS administered 3 times per week, compared with the standard protocol of 5 times per week. Participants will be randomly assigned to frequency condition and depressive symptomatology will be measured weekly using a range of clinician and self-rated questionnaires. Participants will remain in the study for at least 4 weeks, with the option of continuing for a further 2 weeks as judged by the study psychiatrist. It is hypothesised that rTMS administered three times per week will be equally as effective as rTMS administered five times per week in reducing depressive symptomatology.
详细描述
Numerous studies have demonstrated the efficacy of active rTMS over sham rTMS for depression; however, few have systematically studied the optimal frequency of treatment sessions to achieve this efficacy. To date, the majority of studies have administered rTMS every weekday, although this approach has not been widely contested. In addition, most studies have only assessed the effectiveness of rTMS over a two week period, which has resulted in some improvement in depressive symptomatology; however, a longer treatment course would likely result in greater improvement. In this study depressed patients will be randomly assigned to receive rTMS either 3 or 5 times per week, for a period of 4-6 weeks. A range of rating scales will be used to assess the improvement of depressive symptomatology within and between the two frequency groups, to ultimately determine whether TMS is needed 5 times per week to achieve adequate anti-depressant effects or whether 3 times per week is sufficient in achieving a similar level of efficacy for patients.
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
- Single (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
- •Aged >/= 18
- •DSM-IV diagnosis of Major Depressive Episode (bipolar or MDD)
- •MADRS score >/= 20
- •Able to give informed consent
- •Psychoactive medication dosages have been stable for a period of 4 weeks prior to entry in the study
排除标准
- •Co-morbid alcohol or drug abuse or dependence (last 3 months), current eating disorder, mental retardation, schizophrenia, rapid cycling bipolar
- •A history of mood 'switching' in response to other treatments, which cannot be contained by concurrent treatment, e.g., mood stabiliser
- •Pregnancy
- •Significant neurological disorder that increases seizure risk
- •Metal objects in the head, pacemakers, or a history of epilepsy
- •Patients who have failed to respond to a course of ECT in their current episode of depression
- •A high risk of suicide
结局指标
主要结局
Depression Rating Scales
时间窗: weekly
次要结局
未报告次要终点
