Investigation of Efficacy and Response Speed of a Combination Treatment of Escitalopram and Repetitive Transcranial Magnetic Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Evaluation of efficacy and response speed of an Escitalopram-rTMS-combination in the acute treatment of Major Depression.
研究概览
简要总结
We intend to test in a randomized, rater blinded, placebo controlled, prospective study the primary hypothesis that an escitalopram-rTMS-combination treatment is more efficacious in the treatment of refractory major depression assessed with the Hamilton Depression Rating Scale
详细描述
We intend to test in a randomized, rater blinded, placebo controlled, prospective study the primary hypothesis that an escitalopram-rTMS-combination treatment is more efficacious in the treatment of refractory major depression assessed with the Hamilton Depression Rating Scale compared to placebo.
A second hypothesis is that the treatment of MDE with escitalopram (that means in the "Placebo group") alone lead to typical changes like
- An increase in neurotrophic factors concentration (measured by blood concentrations of nerve growth factor (NGF) and brain derived nerve growth factor (BDNF),
- An increase in hippocampal metabolites (measured with magnetic resonance spectroscopy (MRS
- An increase in motor cortical inhibitory activity (measured with motor evoked potentials (MEP
- An increase in serotonergic activity (measured with EEG parameters, Moreover, it is hypothesized that similar but pronounced changes occur in the group treated with the combination treatment.
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
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major Depressive Episode (according to DSM IV standards)
- •HAMD > 20
- •Patient has an IQ > 70 based on the investigator´s judgement
- •Patient is male or nonpregnant female adequately protected from conception
- •Patient is able to comply with all testing and follow-up visit requirements defined by the study protocol
- •Patient has voluntarily signed an informed consent in accordance with institutional policies
排除标准
- •Patient has a history of schizophrenia, schizoaffective disorder or delusional disorder
- •Patient currently has a secondary diagnosis of, or signs of, delirium, dementia, amnestic or other cognitive disorder per DSM IV
- •Patient is suicidal
- •Patient has had an alcohol or substance dependence within the previous 12 month
- •Patient is currently enrolled in another investigational study
- •Patient has a history of, or evidence of, significant central nervous disease (especially seizures)
- •Patient has previously been treated with escitalopram
- •Contraindication against escitalopram or rTMS
结局指标
主要结局
Evaluation of efficacy and response speed of an Escitalopram-rTMS-combination in the acute treatment of Major Depression.
次要结局
- To determine the changes of hippocampal metabolites measured by MRS
- To assess the changes of parameters of motor cortical inhibition measured by MEP
- To assess the changes of NGF and BDNF
- To determine the changes of event related potentials measured by electroencephalography