Transcranial Direct Current Stimulation (tDCS) as Therapeutical Strategy for Negative Symptoms in Schizophrenia: a Double-blind Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Negative Symptoms Rates as assessed by the PAANS
研究概览
简要总结
The current research is aimed at using Transcranial Direct Current Stimulation (tDCS) as complementary therapeutic tool in the treatment of schizophrenia. Patients will be randomized into two groups (tDCS-active x tDCS-sham) accordingly to detailed protocol. Main outcome will be measured by specific clinical rating scales based on the assessment of negative symptoms. A total of 40 patients ought to be enrolled as specified in methodology. Secondary outcomes shall include collateral effects evaluation, anxiety and depressive scales as well as clinical monitoring.
详细描述
Overview
The present study is a double-blind randomized clinical trial in which patients should be allocated from a General Psychiatry Service into two groups (tDCS-active x tDCS-sham). Subjects who fulfilled eligibility criteria will undergo ten days of consecutive stimulation (active or sham) and will return after two to four weeks for final clinical assessment. Patients who shown no response in rating scales and that were allocated to sham intervention group will be able to choose whether or not they want to undergo the active intervention at follow up (partial cross-over)
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with age between 18-59 years
- •diagnostic of Schizophrenia or Schizoaffective Disorder as stated by DSM-IV and confirmed by SCID (Structured Clinical Interview for DSMIV), to be tested by a psychiatrist
- •baseline score higher than 20 for negative symptoms at PAAN
- •patients able to read and understand Portuguese.
排除标准
- •other psychiatric diagnosis
- •criteria for bipolar disorder; dementia; other psychotic disturbs; substance related disorders
- •presence of other severe neurological or clinical diseases
- •presence of suicidal behavior (planning or attempt in the previous 4 weeks)
- •pregnancy
- •incapacity of coping with the informed consent
- •specific tDCS limitations (such as anatomic problems)
- •Regarding medication: all patients should have stable dosology of medications for at least 6 weeks
结局指标
主要结局
Negative Symptoms Rates as assessed by the PAANS
时间窗: Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Positive and Negative Syndrome Scale (PAANS)
Comparison between follow u and baseline PAANS scores with emphasis in negative symptoms scores
次要结局
- Mental Mini Exam(Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Cognitive Screening assessment as performed by the Mental Mini Exam)
- Moca rating Scale(Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Cognitive assessment by MoCa Test)
- Stroop Victoria(Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Cognitive assessment by Stroop - Victoria version)
- Neuropsychological Assessment(Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - neuropsychologial assessment by trained researcher)
研究者
Andre Brunoni
Prof. Dr.
University of Sao Paulo