Double-Blind Vitamin Intervention to Lower Blood Homocysteine Levels: Amino Acid and Clinical Responses in Individuals With Schizophrenia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- blood homocysteine levels
研究概览
简要总结
The purpose of this study is to determine whether individuals with schizophrenia who will take a high dose of the B-vitamins folate, B12 and pyridoxine, may experience improvement in their symptoms.
详细描述
Individuals with schizophrenia often experience disturbing residual symptoms, even with the best available current treatments. Homocysteine, normally found in the body, can interfere with NMDA-glutamate receptor function, and this might be responsible for some of the symptoms of schizophrenia. This double-blind protocol will have study participants who suffer from schizophrenia take either a high-dose combination of folate, B12 and pyridoxine (a combination that can lower homocysteine in the body) or placebo for three months. Clinical measures (e.g., PANSS, CGI) will be taken to determine whether those taking the vitamin combination experience clinical benefit.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Schizophrenia or Schizoaffective Disorder
- •Ages 18-65, male or female
- •Treatment regimen includes a new-generation antipsychotic (clozapine, olanzapine,risperidone, quetiapine, ziprasidone or aripiprazole)
- •Stable medication for 4 weeks prior to screening visit
排除标准
- •Diagnosis of active substance use disorder within the last month
- •Already taking vitamin supplements totaling > 400 mcg folic acid per day, or regular B12 injections
- •Pregnant or breastfeeding
- •Seizure disorder
- •Non-English speaking
- •Without capacity to give informed consent
结局指标
主要结局
blood homocysteine levels
时间窗: 12 weeks after baseline
次要结局
- CGI (Clinical Global Improvement)(12 weeks after baseline)
- CDSS (Calgary Depression Scale for Schizophrenia)(12 weeks after baseline)
- WAIS-II Memory Scale (Immediate and Delayed)(12 weeks after baseline)
- WAIS Digit Symbol-Coding(12 weeks after baseline)
- Wisconsin Card Sorting Test(12 weeks after baseline)
- WAIS-II Letter-Number Sequencing Subtest(12 weeks after baseline)