A Randomized Double-Blind Sham-Controlled Trial of Transcranial Magnetic Stimulation for Refractory Auditory Hallucinations in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Psychotic Symptoms Rating Scale (PSYRATS)
研究概览
简要总结
Studies using repetitive transcranial magnetic stimulation (rTMS) as a treatment for refractory auditory hallucinations (AH) in schizophrenia have shown promise. The majority of studies have examined the effect of low frequency left-sided stimulation (LFL) (i.e., 1 Hz) to the temporal parietal cortex (TPC). Priming stimulation (6 Hz) prior to LFL stimulation (hereby simply referred to as priming) has been shown to enhance the neurophysiological effects of LFL rTMS alone and, as such, may lead to greater attenuation of AH. Therefore, this study evaluated the efficacy of priming rTMS and LFL rTMS, compared to sham, applied to the TPC in patients with schizophrenia experiencing refractory auditory hallucinations (AH).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •voluntary and capable to consent based on the subject's ability to provide a spontaneous narrative description of the key elements of the study
- •have a diagnosis of Schizophrenia or Schizoaffective Disorder as confirmed by the Structured Clinical Interview for the DSM-IV (SCID-IV)
- •between the ages of 18 and 65
- •meet criteria for AH of at least moderate severity based on the Positive and Negative Symptom Scale (PANSS)
- •willing to keep the dose of antipsychotic stable for the duration of the study
- •meet criteria for medication resistance, defined as daily AH despite 2 adequate 6-week trials of at least 2 antipsychotic medications and including 1 atypical antipsychotic medication. An adequate trial is defined as a daily dose of 1000 chlorpromazine equivalents for typical antipsychotics medications and the following dosages for atypical antipsychotic medications: risperidone 6 mg, olanzapine 15 mg, quetiapine 500 mg, clozapine 300 mg.
排除标准
- •DSM-IV history of alcohol and/or substance abuse in past month, or alcohol and/or substance dependence in the last 6 months
- •presence of concomitant major, unstable medical or neurologic illness, or a history of seizures
- •are pregnant
- •have received rTMS for any reason in the past
- •have had a dose change of usual psychotropic medications in the 4 weeks preceding study entry.
结局指标
主要结局
Psychotic Symptoms Rating Scale (PSYRATS)
时间窗: 4 weeks
The primary outcome for this study was response (dichotomous outcome), defined as a 30 percent reduction in the composite score derived from the frequency, duration, loudness and content items of the hallucinations subscale of the Psychotic Symptoms Rating Scale (PSYRATS)
次要结局
- Positive and Negative Symptom Scale - Global(4 weeks)
- Positive and Negative Symptom Scale - Positive subscale(4 weeks)
- Hallucination Change Scale(4 weeks)
- Auditory Hallucination Rating Scale (AHRS)(4 weeks)
研究者
Z. J. Daskalakis
Dr.
Centre for Addiction and Mental Health