NCT01091506已完成不适用
A Placebo-Controlled Study of Physiologic Effects of L-methylfolate in Schizophrenia Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pamlab, Inc.
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Examine the change in plasma L-methylfolate concentrations following a three-month trial of L-methylfolate 15 mg/d compared to placebo.
研究概览
简要总结
This study is a 12-week, double-blind, placebo-controlled trial of L-methylfolate 15 mg/d supplementation in schizophrenia patients with mild or greater negative symptoms. L-methylfolate, a prescription medical food, is the activated form of folate required for conversion of homocysteine to methionine and hence is the optimal form of folate for supplementation, since it eliminates the need for activation by MTHFR. The purpose of this study is to examine the change in plasma L-methylfolate concentrations following a three-month trial of L-methylfolate 15 mg/d compared to placebo.
详细描述
Blood levels of L-methylfolate and biological activity will be evaluated by examining changes in plasma homocysteine concentrations, serum methionine concentrations and changes in brain activation as measured by fMRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia, any subtype
- •Male of female
- •Age 18-68 years
- •Treated with an antipsychotic for at least 6 months at a stable dose for at least 6 weeks
- •PANSS total score of at least 60, with at least 3 (moderate) on one negative symptom item or on one positive symptom item
- •Simpson Angus Scale (SAS) for the EPS total score of 12 or less and
- •A score of 2 (mild) or less on all items of the Calgary Depression Rating Scale (CDRS)
- •Comprehension of English adequate to complete cognitive testing
排除标准
- •Unable to provide informed consent
- •CBC results consistent with megaloblastic anemia
- •Serum creatinine concentration greater than 1.4
- •Current use of folate supplementation > 400mcg folate
- •Alcohol or other substance abuse within 3 months (nicotine allowed)
- •Current use of any of the following medications: phenobarbital, phenytoin, carbamazepine, valproic acid, fosphenytoin, primidone or pyrimethamine
- •Positive baseline urine toxic screen, (positive test for PCP, barbiturates, cannabinoids, amphetamines, benzodiazepines, opiates, or cocaine)
- •Unstable medical illness (exclusionary lab values are listed in Appendix A)
- •Unstable psychiatric illness
- •Seizure disorder
- •Pregnant or nursing, or planning/trying to get pregnant within the next 6 months, and
- •DSM-IV diagnosis of major depressive disorder
结局指标
主要结局
Examine the change in plasma L-methylfolate concentrations following a three-month trial of L-methylfolate 15 mg/d compared to placebo.
时间窗: Weeks 2, 8, and 12
次要结局
- Examine the relationship between MTHFR genotype, change in plasma homocysteine, and methionine concentration, and change in DLPC activation in subjects receiving L-methylfolate(Weeks 2, 8, and 12)
- Examine the change in negative symptoms (SANS total score) after three months compared to placebo(Weeks 2, 8, and 12)
- Examine the change in plasma homocysteine and methionine concentrations following a three-month trial of L-methylfolate 15 mg/d compared to placebo.(Weeks 2, 8, and 12)
- Examine the change in brain activation in patients receiving L-methylfolate 15 mg/d versus placebo as measured by fMRI using Sternberg's Iterm Recognition Paradigm, as well as changes in cortical thickness and connectivity.(Week 12)
- Examine the change in negative symptoms (SANS total score) in relation to change in plasma L-methylfolate levels(Weeks 2, 8, and 12)
- Examine the change in MATRICS cognitive battery composite score after three months in relation to change in plasma L-methylfolate concentration.(Weeks 2, 8, and 12)
- Examine the change in psychotic symptoms (PANSS score) in relation to change in plasma L-methylfolate concentration.(Weeks 2, 8, and 12)
- Examine the change in psychotic symptoms as measured by the PANSS total and subscale scores after three months compared to placebo(Weeks 2, 8, and 12)
- Examine the change in MATRICS cognitive battery composite score after three months compared to placebo(Weeks 2, 8, and 12)
研究者
研究点 (1)
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