Effectiveness of Medial Frontal Repetitive Transcranial Magnetic Stimulation With Double-Cone-Coil in Patients With Major Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 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) is used to modulate the neuronal excitability in patients with depression. In the present study the investigators will examine whether medial frontal rTMS using a double-cone-coil proves to be superior to conventional high-frequency-rTMS applied to the left-sided prefrontal cortex with a butterfly-coil.
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 levels 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's 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. Mild antidepressant effects of rTMS applied to the left sided dorsolateral prefrontal cortex (DLPFC) using a standard butterfly coil can possibly be increased by a different stimulation protocol over the medial frontal cortex using a double-cone-coil. First hints to effectiveness of this treatment arise from case reports and therefore need replication and comparability to conventional stimulation protocols. In the present study the investigators will examine whether medial frontal rTMS using a double-cone-coil proves to be more effective to conventional high-frequency-rTMS applied to the left-sided prefrontal cortex with a butterfly-coil.
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 75 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 old
- •Skills to participate in all study procedures
- •18 or more points in the Hamilton 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: Day 19
次要结局
- Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (Baseline versus end of treatment/ day 19)(Day 19)
- Change in the Clinical Global Impression Scale (Baseline versus end of treatment/ day 19)(Day 19)
- Change in the Alertness (Baseline versus follow-up I/ day 47)(Day 47)
- Change in the Beck Depression Inventory (Baseline versus follow-up II/ day 75)(Day 75)
- Change in the Alertness (Baseline versus end of treatment/ day 19)(Day 19)
- Change in the Clinical Global Impression Scale (Baseline versus follow-up II/ day 75)(Day 75)
- Change in the Beck Depression Inventory (Baseline versus end of treatment/ day 19)(Day 19)
- Change in the Global Assessment of Functioning scale (Baseline versus end of treatment/ day 19)(Day 19)
- Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (Baseline versus follow-up I/ day 47)(Day 47)
- Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (Baseline versus follow-up II/ day 75)(Day 75)
- Change in the Beck Depression Inventory (Baseline versus follow-up I/ day 47)(Day 47)
- Change in the Global Assessment of Functioning scale (Baseline versus follow-up I/ day 47)(Day 47)
- Change in the Global Assessment of Functioning scale (Baseline versus follow-up II/ day 75)(Day 75)
- Change in the Clinical Global Impression Scale (Baseline versus follow-up I/ day 47)(Day 47)
- Change in the Alertness (Baseline versus follow-up II/ day 75)(Day 75)
研究者
Berthold Langguth, MD, Ph.D.
Principal Investigator
University of Regensburg
