Theta Burst Stimulation in Pharmacologically Untreated Patients as Sole Antidepressant
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale
研究概览
简要总结
This is a randomized, controlled trial in which 72 patients with depressive disorder were treated in two study arms using the non-invasive brain stimulation method of intermittent thetaburst intermittent theta burst stimulation (iTBS).
This is a wait-list control study, and the arms differ in the start of the four-week treatment (either promptly i.e., at the beginning of the next week of work) or delayed (start of treatment in four weeks).
The patients to be treated are those who refuse treatment with antidepressant medications.
The effectiveness of the four-week iTBS treatment is to be evaluated in comparison to a "watchful waiting" after 4 weeks.
A interim analysis is planned after 36 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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •uni- or bipolar depression according to ICD-10
- •present episode at least four weeks
- •18-70 years old
- •no intake and rejection of anti-depressant medication and
- •no adequate anti-depressant medication in the present episode
- •no or stable non-drug anti-depressant treatment (e.g. psychotherapy)
- •residency in Germany, German speaking
排除标准
- •contraindications for transcranial magnetic stimulation (electric devices or metal parts in the body such as pacemaker
- •relevant neurological or internistic diseases according to study investigator
- •participation in other trials during treatment
- •pregnancy or breatfeeding
- •legal care and placement in a psychiatric hospital
- •active suicidality
研究组 & 干预措施
active treatment
intermittent theta burst stimulation
干预措施: intermittend theta burst stimulation (iTBS) (Device)
waiting list
patients waiting for intervention
结局指标
主要结局
Hamilton Depression Rating Scale
时间窗: 8 weeks
Hamilton Depression Rating Scale (range: 0-65; higher values = worse outcome)
次要结局
- Major Depression Inventory(20 weeks)
- Hamilton Depression Rating Scale(20 weeks)
- World Health Organisation quality of life bref(20 weeks)
- State Trait Anxiety Inventory(20 weeks)
- clinical global impression(20 weeks)
研究者
Berthold Langguth, MD, Ph.D.
Prof. Dr.
University of Regensburg