Schizophrenia, Related Troubles and Glutathione: Clinical Trial. Effects of Oral Administration of N-Acetylcysteine (NAC) on the Brain Glutathione Level and on the Symptoms of Schizophrenia: Double-blind and Crossover Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 主要终点
- Positive and Negative Syndrome Scale (PANSS)
研究概览
简要总结
The results of the study "schizophrenia, related disorders and glutathione" conducted at the Laboratory of Psychiatric Neuroscience (LUNEP) DUPA of Lausanne, reinforce the hypothesis proposed that a deficit intracerebral glutathione is a vulnerability factor for Schizophrenia at least for a subgroup of patients. While pursuing the baseline study, it is appropriate now to try to restore a higher level of glutathione in patients to see if this increase is accompanied by an improvement in symptoms, particularly negative symptoms and disorders cognitive, particularly resistant to current therapy. N-acetyl-cystein (NAC) is a precursor of glutathione which is used clinically for various indications, well tolerated even at high doses. The investigators propose a double-blind cross-over with the aim to study if the N-acetyl-cystein (at a dose of oral 2g/day) leads on the one hand a rising glutathione brain (measured in resonance magnetic spectroscopic) and also improved patients' conditions (determined by clinical assessments, psychopathological, neuropsychological, biochemical and physiological), while recording any side effects. As a first step, this study should include at least thirty patients and last for two to three years. It is important to note that this is not a study of medication suggested by a pharmaceutical industry, but a medical search.
详细描述
The results of the study "schizophrenia, related disorders and glutathione" conducted at the Laboratory of Psychiatric Neuroscience (LUNEP) DUPA of Lausanne, reinforce the hypothesis proposed that a deficit intracerebral glutathione is a vulnerability factor for Schizophrenia at least for a subgroup of patients. While pursuing the baseline study, it is appropriate now to try to restore a higher level of glutathione in patients to see if this increase is accompanied by an improvement in symptoms, particularly negative symptoms and disorders cognitive, particularly resistant to current therapy. N-acetyl-cysteine (NAC) is a precursor of glutathione which is used clinically for various indications, well tolerated even at high doses. The investigators propose a double-blind cross-over with the aim to study if the N-acetyl-cystein (at a dose of oral 2g/day) leads on the one hand a rising glutathione brain (measured in resonance magnetic spectroscopic) and also improved patients' conditions (determined by clinical assessments, psychopathological, neuropsychological, biochemical and physiological), while recording any side effects. As a first step, this study should include at least thirty patients and last for two to three years. It is important to note that this is not a study of medication suggested by a pharmaceutical industry, but a medical search.
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
- Triple (Participant, Care Provider, Investigator)
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
- 是
入选标准
- •patients (male or female, aged 18 to 65 years, QI>70) meeting the DSM-IV criteria (established by a senior psychiatrist) for schizophrenia and have the capacity to consent to the study. The study population include both inpatients and outpatients who are currently taking at least one of the following:Olanzapine, Clozapine, Haloperidol, Risperidone, Flupenthixol, or Fluphenazine. The following guidelines have been established for potential medication changes that patients may undergo during the course of the trial.
- •dose changes to existing medication (either increases or decreases in dose) will be accepted and participants will be allowed to continue with the trial.
- •A change in primary antipsychotics from one medication to another will require participants to withdrawn from the study.
- •An addiction of another antipsychotic, secondary to the existing antipsychotic treatment (primary antipsychotic) will be acceptable providing that there isn't a complete change from one antipsychotic to another.
排除标准
- •pregnancy
- •acute psychotic state, preventing the patient cooperation
- •co-morbidity with drug dependency
- •organic cerebral disease, major somatic diseases
- •abnormal renal, hepatic, thyroid or hematological findings
- •treatment with a regulator of mood(lithium, valproate, topiramate, lamotrigine et carbamazepine)
- •allergy to NAC
- •treatment with antioxidants
研究组 & 干预措施
patients who receive NAC first
this group will receive 2g/day of NAC (2 caps of 0.5g twice day)for a duration of 8 weeks first, and after this 8 weeks their receive placebo for 8 weeks.
干预措施: N-Acetyl-Cysteine (NAC) (Drug)
patients who receive placebo first
this patients will receive first placebo for a duration of 8 weeks, and after this 8 weeks their receive NAC for 8 weeks
干预措施: N-Acetyl-Cysteine (NAC) (Drug)
结局指标
主要结局
Positive and Negative Syndrome Scale (PANSS)
时间窗: 8 months
Improvment of the negative symptoms, measured with the PANSS: positive and negative syndrome scale". (Score:1= absence of the symptom - 7= extreme symptoms)
次要结局
- Global Assessment of Functioning - (GAF)(8 months)
- Neurological scales for the assessment of extrapyramidal symptoms(8 months)
- • Magnetic Resonance Spectroscopy (MRS)(8 months)
- EEG/evoked potentials(8 months)
- Blood and fibroblasts biochemistry(8 months)
- frankfurt Complaint Questionnaire (FCQ)(8 months)
- Clinical Global Impression - (CGI)(8 months)
- Neuropsychological evaluation(8 months)
研究者
Dresse Kim Q. Do
Professor
Centre Hospitalier Universitaire Vaudois