Treatment of Negative Symptoms of Schizophrenia by Repetitive Transcranial Magnetic Stimulation: A Naturalistic Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Evaluate the efectiveness of rTMS on the negative symptoms of schizophrena, assessed by the SANS ( Scale Assessment Negative Symptoms).
研究概览
简要总结
The purpose of this study is to assess the effectiveness of rTMS on the negative symptoms of schizophrenia in real conditions. It will also provide a regulatory framework to rTMS treatments under these conditions. 4 types of rTMS protocols are proposed, allowing to adapt to patients and their tolerances.Treatment lasts between 2 and 4 weeks, with a follow-up period of 3 months after treatment to observe relapses.To assess the evolution of negative symptoms between baseline and the end of treatment, investigators use SANS (Scale for the Assessment of Negative Symptoms).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over 18 years of age
- •Patient diagnosed with schizophrenia according to the DSM-V criteria (Diagnostic and Statistical Manual of Mental Disorder V5, 2013)
- •Stable drug treatment for at least 4 weeks
- •Presence or persistence of negative symptoms in the foreground:
- •Negative PANSS score ⩾21, positive PANSS score ⩽24
- •Patient (or legal representative) willing to participate in the study and having signed an informed consent
- •Patient fluent in the French language
- •Affiliation to a social security scheme
排除标准
- •Present a contraindication to TMS: intracranial foreign body, unstabilized epilepsy, cochlear implant, pace-maker
- •Presence of an unstabilized medical condition
- •Pregnant woman
- •Woman of childbearing potential and without effective contraception
- •Breastfeeding woman
结局指标
主要结局
Evaluate the efectiveness of rTMS on the negative symptoms of schizophrena, assessed by the SANS ( Scale Assessment Negative Symptoms).
时间窗: Baseline (day 1) to end of treatment (2 or 4 weeks)
The SANS is a scale used for negative symptoms that is initially made up of 19 items divided into five sub-scales: emotional blunder, pedigree, avolition-apathy, anhedonia and social withdrawal. Based on the percentage reduction of this score after 2-4 weeks, patients will be allocated according to the following criteria: * Remission: 75% * Effective treatment: 50-74% * Improvement/response: 25-49% * No answer: \<25%
次要结局
- Evaluate the impact of this treatment on general psychopathology assessed by PANSS and CGI.(Baseline (day 1), end of treatment (2 or 4 weeks), 4 weeks, 12 weeks and 24 weeks after the end of treatment.)
- Assess the impact of this treatment on response rate by the SANS(Baseline (day 1) to end of treatment (2 or 4 weeks))
- Assess the impact of this treatment on the rate of remission by the number of remission with the SANS(Baseline (day 1) to end of treatment (2 or 4 weeks))
- Assess the impact of this treatment on the relapse rate by the number of relapse with SANS(4 weeks, 12 weeks and 24 weeks after the end of treatment.)
- Assess the impact of this treatment on cognitive symptoms by MOCA (Montreal Cognitive Assessment) and STROOP(Baseline (day 1) to end of treatment (2 or 4 weeks))
- Assess the impact of this treatment on addictive attitudes by MCQ (Marijuana Craving Questionnaire) and CAST (Cannabis Abuse Screening Test)(Baseline (day 1) to end of treatment (2 or 4 weeks))
- Assess the impact of this treatment on mood by CDSS (Calgary Depression Scale for Schizophrenia).(Baseline (day 1) to end of treatment (2 or 4 weeks))
- Assess the impact of this treatment on quality of life by S-QoL-18(Baseline (day 1), end of treatment (2 or 4 weeks), 4 weeks, 12 weeks and 24 weeks after the end of treatment.)
- Assess the impact of this treatment on adverse reactions by the CGI(Baseline (day 1), end of treatment (2 or 4 weeks), 4 weeks, 12 weeks and 24 weeks after the end of treatment.)
研究者
Dominique JANUEL
Head of clinical research unit
Centre hospitalier de Ville-Evrard, France