Efficacy of repetitive transcranial magnetic stimulation for the treatment of negative symptoms in schizophrenia

精神分裂症是一种严重的精神障碍，给患者及其亲属带来了巨大的负担。尽管用第二代抗精神病药物治疗，阴性症状和认知障碍往往持续存在，并决定一个不利的过程，包括生活质量下降。前额叶重复经颅磁刺激（rTMS）是一种很有前途的无创生物技术，应用于正在进行的抗精神病治疗是安全的，并且在大多数小型安慰剂对照试验中与阴性症状的改善有关。然而，关于疗效的数据仍然没有定论。需要更大样本量和更长的治疗期的对照试验才能达到I级疗效证据（根据循证医学标准）。这项建议的研究是一项随机、平行组、受试者和患者盲设计试验，比较了126名主要症状为阴性的精神分裂症患者的真实rTMS和安慰剂rTMS。所有患者在3周内接受真实或安慰剂（假）rTMS作为附加治疗，并将在进一步的12周随访期间进行评估。该研究的结果将回答rTMS是否是一种有效的基于证据的精神分裂症阴性症状的附加干预措施的问题，这种治疗技术将成为改变精神分裂症不利病程的治疗选择，需要在临床实践中建立。

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. However, the data on efficacy remain inconclusive. Controlled trials with larger sample sizes and longer treatment periods are required to reach level I evidence of efficacy (according to evidence based medicine criteria). The suggested study is a randomized, parallel-group, rater- and patients-blind design trial and compares real and placebo rTMS in 126 schizophrenic patients suffering from predominantly negative symptoms. All patients receive either real or placebo (sham-) rTMS as add-on treatment over a period of 3 weeks and will be assessed during a follow-up period of further 12 weeks. The results of the study will allow to answer the question whether rTMS is an effective evidence-based add-on intervention in the negative symptoms in schizophrenia, this treatment technique will be a therapeutic option to change the unfavourable course of schizophrenia and needs to be established in clinical practice.