D-Serine Monotherapy for Schizophrenia
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 2
研究概览
简要总结
N-methyl-D-aspartate receptor (NMDAR) agonist, added to classical or atypical antipsychotic medication, has reduced negative, depressive, and cognitive symptomatology. We will be investigating the effect of D-serine, (DSR), a selective and potent NMDAR agonist, as monotherapy for treatment resistant schizophrenics.
40 subjects on stable doses of risperidone will be randomized under double-blind conditions into a treatment group, which will receive D-serine 2100 mg, or a control group, which will continue to receive risperidone. Treatment will continue for 14 weeks.
Symptoms and side effects will be rated biweekly with the CGI, PANSS, BPRS, SAS, AIMS, and UKU. Before and after the trial subjects will undergo neuropsychological assessments. Baseline and post-trial levels of amino acids relevant to glutamatergic neurotransmission (glutamate, glutamine, aspartate, glycine, serine, alanine) will be assessed.
The primary outcome measures of the study will be the PANSS total scores and the positive and negative symptom cluster scores.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV criteria for chronic schizophrenia
- •Treatment resistant
- •Two months on stable risperidone dose
- •PANSS positive symptom cluster score >20
- •PANSS negative symptom cluster score >22
排除标准
- •Substance abuse
- •Concurrent DSM IV axis I disorder
- •Serious medical disorder
- •Concurrent drug therapy that can obscure the effect of risperidone or DSR.