Treatment of Resistant Auditory Hallucinations in Schizophrenia by Repetitive Transcranial Magnetic Stimulation. Naturalistic Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The evolution will be evaluated mainly with the AHRS (Auditory Hallucinations Rating Scale)
研究概览
简要总结
This open naturalistic study aims to evaluate the efficacy of rTMS in routine practice on auditory resistant hallucinations (AHR) of patients with schizophrenia. To this end, two stimulation methods will be offered to patients: the rTMS stimulation method and the cTBS stimulation method.We principally use the AHRS scale to evaluate the effectiveness of rTMS on RAH in patients with schizophrenia. Our main hypothesis is that rTMS used under naturalistic conditions, in addition to antipsychotics, would allow a relative improvement of resistant auditory hallucinations assessed by the AHRS scale between baseline and end of treatment in patients with schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（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 DSM-V criteria (Diagnostic and Statistical Manual of Mental Disorder V5, 2013)
- •Presence of auditory hallucinations: Resistant auditory hallucinations: resistance to treatment with 2 different well-conducted antipsychotics.
- •Patient agreeing to participate in the study and having signed an informed consent
- •Patient with French language skills
- •Affiliation to a social security system
- •Women of childbearing age must be on contraception and have a negative pregnancy test (βHCG)
排除标准
- •Have a contraindication to MST: intracranial foreign body, unstabilized epilepsy, cochlear implant
- •Presence of an unstabilized medical condition
- •Pregnant woman (Women of childbearing age without effective contraception)
- •Current or less than one month old engagement in another research protocol
- •A person who is subject to a safeguard of justice measure
- •An adult under curatorship
- •Minor patients with mental health problems
- •Pregnant or breastfeeding women
- •A person in a social fragility (Persons deprived of liberty by a judicial or administrative decision, hospitalized persons)
- •Persons incapable or unable to give consent
结局指标
主要结局
The evolution will be evaluated mainly with the AHRS (Auditory Hallucinations Rating Scale)
时间窗: Baseline and at the end of the treatment, also at 1 month and 3 months after the end of the treatment
Refer to the definition of AHRS above (in Primary Outcome Measure)
次要结局
- Response rate: a response is defined as a decrease greater than or equal to 30% of total AHRS score from baseline to end of treatment.(Baseline and at the end of the treatment)
- Rate of patients with an end-of-treatment score < 3 on the Positive And Negative Syndrome Scale (PANSS) "Hallucinatory Behavior" item(Baseline and at the end of the treatment)
- Cognitive symptoms: Montreal Cognitive Assessment (MOCA), Stroop(Baseline and 1 month after the end of treatment)
- Addictive attitudes: number of cigarettes/d (tobacco), The Cannabis Abuse Screening Test (CAST), Marijuana Craving Questionnaire (MCQ)(Baseline and at the end of the treatment)
- Mood: Calgary Depression Scale for Schizophrenia (CDSS)(Baseline and the end of the treatment)
- Quality of life: The Subjective Quality of Life Scale (S-QoL)(Baseline and end of treatment, also at 1 month and 3 months after the end of the treatment)
- Clinical Global Impressions (CGI) Scale(Baseline and end of treatment, also at 1 month and 3 months after the end of the treatment)
研究者
Dominique JANUEL
Head of clinical research unit
Centre hospitalier de Ville-Evrard, France