Treatment of Negative Symptoms of Schizophrenia With Transcranial Direct Current Stimulation (tDCS): A Randomized, Double-blinded, Sham-controlled, Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in subscale of PANSS
研究概览
简要总结
The aim of this study is to evaluate the therapeutic efficacy of tDCS (transcranial direct current stimulation) for treatment of negative symptoms in patients with schizophrenia. The proposed design is a clinical trial, randomized, double-blind, placebo-controlled study. Participants will receive ten sessions of active or sham stimulation in five consecutive days. 100 patients will be randomized into two groups (active tDCS vs sham tDCS) and will be assessed after the intervention: 2, 4, 6 and 12 weeks after. As objectives, the investigators expect to see a clinical improvement of negative symptoms through scales PANSS (Positive and Negative Syndrome Scale), Calgary, Auditory verbal hallucinations, SANS (Skills for Assessment of Negative Symptoms), and expect improvement on computerized cognitive tests. Another goal is to see improvement in biological markers related to schizophrenia, plasma and DNA will be stored.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Diagnosis of schizophrenia according to DSM-IV criteria and confirmed by the SCID
- •Minimum score of 20 points in the sum of negative PANSS
- •Stable antipsychotic medications
排除标准
- •Unstable medical illness
- •Uncontrolled pretreatment with rTMS or tDCS
- •At least six months without being in ECT
- •Benzodiazepines in doses of 10mg of diazepam
- •Electronic or metal implants in the cephalic segment.
- •Other mental disorders and dependence of substances
研究组 & 干预措施
Active tDCS
Sham Comparator: Sham Stimulation In active stimulation, the anode is placed over the left dorsolateral prefrontal cortex and the cathode is placed over the temporo-parietal cortex with the Transcranial Direct Current Stimulation. The device will deliver a charge of 2mA for 20 minutes.
干预措施: Transcranial Direct Current Stimulation (Device)
Sham tDCS
Sham Comparator: Sham Stimulation In active stimulation, the anode is placed over the left dorsolateral prefrontal cortex and the cathode is placed over the temporo-parietal cortex with the Transcranial Direct Current Stimulation. The device will deliver a charge of 2mA for 1 minute, after that the device will be automatically turned off for 19 minutes.
干预措施: Transcranial Direct Current Stimulation (Device)
结局指标
主要结局
Change in subscale of PANSS
时间窗: Repeated measures: 0, 2, 4 and 6 weeks (endpoint)
Reduction of PANSS negative subscale (continuous measure) at 6 weeks
次要结局
- Change in Negative subscale of PANSS(12 weeks)
- Change in Auditory Verbal Hallucination Scale(Repeated measures: 0, 2, 4, 6 and 12 weeks)
- Change in SANS(Repeated measures: 0, 2, 4, 6 and 12 weeks)
研究者
Leandro Valiengo
Medical Assistance
University of Sao Paulo