Effectiveness of Theta-burst Stimulation (TBS) Versus Tonic High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS)in Patients With Major Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Change in depression severity measured by the 21-item Hamilton Depression Rating Scale (Baseline versus end of treatment/ day 19)
研究概览
简要总结
Repetitive Transcranial Magnetic Stimulation (rTMS) as well as Theta- Burst Stimulation of the frontal cortex are used to modulate the neuronal excitability in patients with depression. In the proposed study we investigate whether high frequent rTMS or Theta-Burst Stimulation of the DLPFC is more effective in patients with a depressive episode.
详细描述
Depression is a common mental disorder that presents with depressed mood, loss of interest, feelings of guilt or low self-worth, disturbed sleep or appetite, low energy, and poor concentration. These problems can become chronic or recurrent and lead to substantial impairments in an individual's ability to take care of his or her everyday responsibilities, at its worst, depression can lead to suicide.Depression can be reliably diagnosed in primary care. Antidepressant medications and brief, structured forms of psychotherapy are effective for 60-80 % of those affected and can be delivered in primary care.
In patients with depression the cerebral metabolism is deranged in some specific areas such as hypoexcitability in frontal cortical areas. High-frequency rTMS of the dorsolateral prefrontal cortex (DLPFC) has been investigated for the treatment of hypoexcitability disorders. Pilot data indicate that the mild effects of the rTMS could be increased by a special kind of TMS, the Theta-burst stimulation. In the proposed study we investigate whether high frequent rTMS or Theta-Burst Stimulation of the DLPFC is more effective in patients with a depressive episode.
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
- Double (Participant, Investigator)
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
- •Episode of depression (unipolar or bipolar)( ICD-10)
- •Female or male between 18 and 70 years
- •Skills to participate in all study procedures
- •18 or more points in the Hamiliton rating scale or depression
- •Stable antidepressant drugs
- •Written informed consent
排除标准
- •Clinically relevant unstable internal or neurological comorbidity
- •Evidence of significant brain malformations or neoplasm, head injury
- •Cerebral vascular events
- •Neurodegenerative disorders affecting the brain or prior brain surgery
- •Metal objects in and around body that can not be removed
- •Pregnancy
- •Alcohol or drug abuse
- •Epilepsy or a pathological EEG
- •Heart pacemaker
- •High dose tranquillizers
结局指标
主要结局
Change in depression severity measured by the 21-item Hamilton Depression Rating Scale (Baseline versus end of treatment/ day 19)
时间窗: 19 days
次要结局
- Change in the Beck Depression Inventar, the Clinical Global Impression Scale, the Global Assessment of Functioning scale, the Alertness (Baseline versus end of treatment/ day 19, follow-up I/ day 47, follow-up II/ day 75)(75 days)
- Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (Baseline versus end of treatment/ day 19, follow-up I/ day 47, follow-up II/ day 75)(75 days)
研究者
Berthold Langguth, MD, Ph.D.
MD, Ph.D.
University of Regensburg