A Placebo-Controlled Trial of Folate With B12 in Schizophrenia Patients With Residual Symptoms
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 6
- 主要终点
- Positive and Negative Syndrome Scale (PANSS)
研究概览
简要总结
This study will evaluate the effectiveness of folate and B12 supplementation in reducing negative symptoms in people with schizophrenia.
详细描述
About 30% of people with schizophrenia suffer from treatment-resistant psychotic symptoms, which may include social withdrawal, apathy, and depression. These negative symptoms can produce substantial distress for those affected, often disrupting social and occupational functioning and resulting in hospitalization. Although atypical antipsychotic medications have demonstrated some success in treating negative symptoms, the degree to which many negative symptoms respond is unclear. Depression and poor response to antidepressant medication have been linked to deficiency in the vitamins folate and B12. It is believed that vitamin supplementation with folate and B12 may offer a safe and inexpensive approach to improve outcomes for people with schizophrenia who have residual negative symptoms and have exhibited poor treatment response. This study will compare the effectiveness of folate and B12 versus placebo in reducing negative symptoms in people with schizophrenia.
Participation in this double-blind study will last 19 weeks. Potential participants will undergo initial screening, which will include a medical and psychiatric evaluation, physical exam, blood draw, urine sampling, and questionnaires. Participants will also be asked for permission to use a portion of the blood sample for genetic analysis. Eligible participants will be randomly assigned to take folate with B12 or placebo. Participants will first complete a 2-week stabilization phase, followed by the 16-week treatment study. Medication visits, occurring every 2 weeks during treatment, will include questions about medication side effects and the distribution of study medication. During specified medication visits, participants will complete various assessments, which will include questionnaires about schizophrenia, tests of learning and memory, repeat blood tests, and pregnancy tests. The medication visits will last between 15 minutes and 4 hours, depending on the scheduled assessments for that visit.
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
- 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
- •Treated with an antipsychotic medication for at least 6 months at a stable dose for at least 6 weeks before study entry
- •PANSS total score of at least 60, with a score of at least 3 (moderate) on one negative symptom item or on one positive symptom item
- •Simpson Angus Scale (SAS) for Extrapyramidal Syndrome (EPS) total score of 12 or less
- •A score of 2 (mild) or less on all items of the Calgary Depression Scale (CDS)
- •Speaks English adequately enough to complete cognitive testing
排除标准
- •Serum B12 concentration less than 300 ug/L
- •Complete blood count results consistent with megaloblastic anemia
- •Serum creatinine concentration greater than 1.4
- •Current use of folate or B12 supplementation
- •Current use of any of the following medications: phenobarbital, phenytoin, carbamazepine, valproic acid, fosphenytoin, primidone, or pyrimethamine
- •Alcohol or other substance abuse within 3 months before study entry (nicotine allowed)
- •Positive baseline urine toxic screen
- •Unstable medical illness
- •Unstable psychiatric illness
- •Seizure disorder
- •Pregnant or breastfeeding
结局指标
主要结局
Positive and Negative Syndrome Scale (PANSS)
时间窗: Baseline vs. Week 16
The change from baseline on the Positive and Negative Syndrome Scale (PANSS).The PANNS has three subscales: positive (score range 7-49), negative (score range 7-49), and general psychopathology (score range 16-112). The PANSS positive symptom sub-scale is comprised of 7 items rated on a scale of 1-7, representing positive symptoms of schizophrenia. The PANSS negative symptom subscale is comprised of 7 items rated on a scale of 1-7 representing the negative symptoms of schizophrenia, and the general psychopathology subscale is comprised of 16 items rated on a scale of 1-7 representing symptoms of general psychopathology in mental illness. The total score was computed by adding all the items on the sub-scale together. Scores reported are change in symptoms per week, relative to baseline. A negative score represents a decrease in total PANSS score per week, whereas a positive score represents an increase in total PANSS score per week.
次要结局
- Cognitive Deficits, as Measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Cognitive Battery Composite Score(Measured at Week 16)
- Positive and Negative Syndrome Scale (PANSS) and FOLH1, MTHRF, MTR, and COMT Genotype(Baseline vs. Week 16)
- Relationship Between Response of Negative and Positive Symptoms and the Change in RBC Folate, Serum Folate, Serum B12, and Plasma Homocysteine Concentrations(Measured at Week 16)
- Positive Sub Scale of the Positive and Negative Syndrome Scale (PANSS)(Baseline vs. Week 16)
- Scale for Assessment of Negative Symptoms (SANS)(Baseline vs. Week 16)
研究者
Donald C. Goff, MD
Director of the Schizophrenia Clinical and Research Program
Massachusetts General Hospital