A Sham-controlled Crossover Study Using Photoneuromodulation to Treatment the Negative Symptoms of Schizophrenia.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in Subcale of PANSS
研究概览
简要总结
Abstract: Randomized clinical trial that aims to see the efficacy of photoneuromodulation for the treatment of negative symptoms of schizophrenia in patients refractory to transcranial direct current stimulation. In this group of 30 refractory volunteers, magnetic resonance spectroscopy will be performed before and after photoneuromodulation in a cross-over design.
Objectives: Effectiveness of photoneuromodulation in patients with schizophrenia. . Analysis of glutamate, Gaba and lactate in spectroscopy before and after stimulation (secondary) Sample: 30 volunteers with negative symptoms of schizophrenia refractory to treatment.
Method: clinical trial, cross-over randomized, double-blind, sham-controlled. PANSS negative symptoms subscale evaluation before and after the 10 photoneuromodulation sessions. Participants who are in the active group after the 10 photoneuromodulation sessions will go to the sham group and vice versa. They will perform magnetic resonance spectroscopy before the beginning, after the 10 sessions and again after the inversion of the groups (3 resonances per volunteer). The study will be a cross-over: half of participants will start at sham group and the other half at active group and invert groups after 10th day of stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
We have two identical devices (a and b), that are equal in all aspects, but one of them is sham (does not product infrared (IR) light). As IR light is invisible for human eyes, neither the applicant of the procedure neither the participant will know if it is active or sham. All the participants had a code after randomization that does the allocation to sham or active. The machine (a or b) was chosen for an external researcher that has no contact with the team of the research.
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
- •Patients between 18 and 55 years
- •Diagnosis of schizophrenia according to DSM-IV criteria and confirmed by the SCID (Structured Clinical Interview for DSMIV), which will be applied by a psychiatrist, will be included.
- •Minimum score of 20 points in the sum of negative PANSS
- •Stable antipsychotic medications
- •There is a need for at least one trial with at least one antipsychotic in adequate dose and time to enter the study.
排除标准
- •Unstable or uncontrolled clinical diseases,
- •Psychiatric comorbidities,
结局指标
主要结局
Changes in Subcale of PANSS
时间窗: Weeks 0, 2 and 4
Continuos measure (score changes)
次要结局
- Changes in PANSS(Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12])
- Changes in Brief Negative Symptom Scale (BNSS)(Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12])
- Changes in Calgary(Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12])
- Changes in WHOQOL(Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12])
- Changes in SOFAS(Time Frame: Weeks 0,1, 2, 3, 4, 6, 12])
- Changes in SANS(Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12])
- Changes in parameters of spectroscopy (lactate, glutamate, glicine and GABA)(Time Frame: Weeks 0, 2, 4])
研究者
Leandro Valiengo
Medical Assistance
University of Sao Paulo