Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Negative Symptoms in Schizophrenia - a Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 197
- 试验地点
- 6
- 主要终点
- Improvement in negative symptoms (baseline vs. day 21, PANNS negative sum score)
研究概览
简要总结
Schizophrenia is a major psychotic disorder that presents an enormous burden to the patients and their relatives. Despite treatment with second generation antipsychotics, negative symptoms and cognitive impairment often persist and determine an unfavourable course including reduction in life quality. Prefrontal repetitive transcranial magnetic stimulation (rTMS), a promising noninvasive biological technique, applied adjuvant to ongoing antipsychotic treatment was demonstrated to be safe and was associated with improvement in negative symptoms in the majority of the small placebo-controlled trials.
The primary objective of the trial is to investigate the efficacy of high-frequency rTMS (add-on to antipsychotic therapy) in the treatment of negative symptoms in schizophrenia compared to sham stimulation (placebo).
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female in-patients and out-patients, 18 - 60 years of age
- •Diagnostic criteria for schizophrenia according to ICD-10/DSM IV
- •PANSS negative sum score > 20 points, 1 of items N1 - N7 (range 1 to 7) ≥ 4 (at least moderate)
- •Improvement in PANSS negative sum score less than 10 % in the last 2 weeks prior to study entry, stable antipsychotic medication
- •Informed Consent
排除标准
- •Clinically relevant psychiatric comorbidity, verbal IQ < 85
- •History of epileptic seizures, organic brain disease
- •Instable medical comorbidity or condition
- •Previous treatment by rTMS
- •Factors not compatible with the use of TMS, e.g. cardiac pace makers or other metallic implants, pregnancy
结局指标
主要结局
Improvement in negative symptoms (baseline vs. day 21, PANNS negative sum score)
时间窗: 105 Days
次要结局
- efficacy on cognition, EPS, neuroplasticity (sMRI/MRS), depression, life quality and social function(105 days)