Efficacy and Safety of High-frequency Repetitive Transcranial Magnetic Stimulation With H7-coil in the Treatment of Schizophrenia Negative Symptoms; A Multicenter, Randomized, Sham Controlled, Triple Blind Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Adjusted median of differences in total SANS score
研究概览
简要总结
Primary objective: to examine the efficacy and safety of high frequency repetitive transcranial magnetic stimulation (HF rTMS) with H7-coil applied once daily during the twenty days, augmentative to the standard antipsychotic pharmacotherapy and other treatment of negative symptoms in schizophrenia.
Targeted population: patients diagnosed with schizophrenia, 18-55 years old with predominant negative symptoms, stable condition for >3 months and unchanged antipsychotic therapy for >1 months and no treatment with antidepressants.
Study design: industry independent, multicenter, prospective randomized sham-controlled, two-arms, triple-blind superiority clinical trial with concealed allocation and masked independent outcome assessment.
Primary outcome: adjusted median of differences in total SANS score. Adjustment for age, gender, baseline total SANS score, duration of the disorder, and antipsychotic therapy.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmation diagnosis of schizophrenia (ICD-10 F20) using the Mini-International Neuropsychiatric Interview (MINI) (Lecrubier et al., 1997; Sheehan et al., 1998),
- •Age 18-55 years,
- •Both genders,
- •PANSS negative symptoms subscale score >24,
- •PANSS positive symptoms subscale score <20,
- •Stable condition (no acute psychosis exacerbation, no psychiatric hospitalization because of relapse or worsening of symptoms) during at least three months,
- •Stable antipsychotic therapy with no change of drugs or doses during the one months before the enrollment.
排除标准
- •Antipsychotics dose change or change of antipsychotic drug,
- •Hospitalization for somatic illness in another institution,
- •Termination of treatment in a Psychiatric Hospital "Sveti Ivan",
- •Missed more than three consecutive interventions,
- •Withdrawal of consent to participate for the sake of intolerance of TMS or for other reasons.
结局指标
主要结局
Adjusted median of differences in total SANS score
时间窗: assessed up to 20 days of treatment
Adjusted median of differences in total SANS score (Andreasen, 1989). We will adjust the medians for age, gender, baseline total SANS score, duration of the disorder, and antipsychotic therapy
次要结局
- Change in SNS score(assessed up to 20 days of treatment)
- Change in PANSS negative symptom subscale with items rescaled to 0-6 range(assessed up to 20 days of treatment)
- Change of BNSS score(assessed up to 20 days of treatment)
- Change in CDSS score(assessed up to 20 days of treatment)