Effects of Oral N-Acetyl-Cysteine (NAC) in the Early Phase of Schizophrenia Spectrum Psychosis: Randomized, Parallel, Double- Blind, Placebo Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Negative Symptoms of Schizophrenia as Measured on the PANSS
研究概览
简要总结
The investigators seek to examine the effect of add-on N-Acetyl-Cysteine (NAC) in the early phase of schizophrenia spectrum illness in collaboration with researchers Kim Do, PhD, and Philippe Conus, MD in Switzerland. Modifications of brain structure are thought to occur during the pre-illness phase and around the transition to psychosis. Therefore, studying new treatments that could target changes occurring during this period is of critical importance.
Aims:
Does add-on NAC treatment in early psychosis influence:
- positive and negative symptoms
- extrapyramidal side-effects of other medication
- plasma concentration of glutathione
- Mismatch Negativity, a physiological marker
详细描述
The study proposes that a glutathione deficit leading to an abnormal response to oxidative stress is a vulnerability factor, combined with other brain specific factors, in brain functioning of some individuals with schizophrenia (Do et al., 2010). N-acetyl-cysteine is hypothesized to cross the blood-brain barrier and increase glutathione in the brain.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capacity to provide informed consent
- •DSM IV TR diagnosis of schizophrenia, schizophreniform, schizoaffective
- •Psychiatric and medical stability
- •Prescribing clinician's premission to participate, assurance of medical stability
- •Having met threshold criteria for psychosis on CAARMS (Comprehensive Assessment of at Risk Mental States Scale) Psychosis subscale
- •Up to 12 months of antipsychotic treatment
排除标准
- •Severe medical comorbidities
- •Previous cerebral trauma
- •Substance induced psychosis or organic psychosis
- •Mental retardation
- •NAC allergy
- •Pregnancy, females and males planning pregnancy
- •Treatment with antioxidants
- •Insufficient command of English
研究组 & 干预措施
n-acetyl-cysteine
N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks
干预措施: n-acetylcysteine (Drug)
Placebo
matching effervescent tablets in water 2 in am and 1 in pm
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Negative Symptoms of Schizophrenia as Measured on the PANSS
时间窗: at 6 months
Positive and Negative Symptom Scale was used to assess psychopathology. The sum of items N1 - N7 including N1) blunted affect, N2) emotional withdrawal, N3) poor rapport, N4) passive apathetic social withdrawal, N5) difficulty in abstract thinking, N6) lack of spontaneity and flow of conversation, and N7) sterotyped thinking were used to analyze negative symptoms of schizophrenia and were assessed for the previous week: RATING SCALE 1: Absent 2: Minimal 3: Mild 4: Moderate 5: Moderate Severe 6: Severe 7: Extreme The higher the score the worse the symptoms. The lowest possible score is 7 and the highest possible score is 49 .
次要结局
- Global Assessment of Functioning (GAF)(at 6 months)
- Change in Cognition and Working Memory (MATRICS) Reasoning and Problem Solving(at 6 months)
- Social and Occupational Functioning Assessment Scale (SOFAS)(at 6 months)
- Change in Cognition and Working Memory (MATRICS) Verbal Learning(at 6 months)
- Change in Cognition and Working Memory (MATRICS) Visual Learning(at 6 months)
- Change in Cognition and Working Memory (MATRICS) Working Memory(at 6 months)
- GPxbc Glutathione Peroxidase Activity in Blood Cells(at 6 months)
- Glutamine Brain Level for NAC Group(at 6 months)
- Change in Positive Symptoms (PANSS)(at 6 months)
- Change in Cognition and Working Memory (MATRICS) Attention and Vigilance(at 6 months)
- Change in Blood Level of Glutathione(at 6 months)
- Change in Cognition and Working Memory (MATRICS) Speed of Processing(at 6 months)
- Glutamine Brain Level for Placebo Group(at 6 months)
- Glutamate Brain Level for NAC Group(at 6 months)
- Glutamate Brain Level for Placebo Group(at 6 months)
- Glutathione Brain Level for NAC Group(at 6 months)
- Blood Plasma Level of Cysteine(at 6 months)
- Glutathione Brain Level for Placebo Group(at 6 months)
- Myo-Inositol Brain Level for the NAC Group(at 6 months)
- Myo-Inositol Brain Level for Placebo Group(at 6 months)
研究者
Larry Seidman
Principal Investigator
Beth Israel Deaconess Medical Center