D-Serine Augmentation of Cognitive Retraining in Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Positive and Negative Syndrome Scale (PANSS)
研究概览
简要总结
This study will examine the effectiveness of D-serine in increasing and sustaining the benefits of cognitive retraining in people with schizophrenia.
详细描述
This study is based on the hypothesis that by increasing NMDA receptor function in the brain and thereby increasing the capacity of the brain to both form new connections and strengthen existing connections, schizophrenic patients may derive both greater and sustained benefit from cognitive retraining.
Patients with schizophrenia or schizoaffective disorder who are currently receiving antipsychotic medication will be randomly assigned in a double-blind manner to receive either D-serine (30 mg/kg) or placebo in addition to cognitive rehabilitation or a non-interactive placebo for 12 weeks.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia or schizoaffective disorder
- •Clinically stable
- •Treated with antipsychotic medications for at least 6 months in the past, and on a stable dose of the same antipsychotic medication over the past month
- •Not pregnant or lactating
排除标准
- •Other current or past DSM-IV Axis I diagnosis
- •Calgary Depression scale score >10 or Simpson-Angus Rating Scale score > 20
- •Currently treated with clozapine, lamotrigine or carbamazepine, or defined as treatment refractory
- •Substance abuse or dependence within the past 3 months, except for nicotine
- •Wechsler Adult Intelligence Scale-Revised score < 70
- •Significant recent (within past 3 months) risk of committing suicide
- •Abnormal thyroid function tests within the last 6 months
- •Previous treatment with D-serine
- •History of evidence of a medical or neurological condition that would expose the subject to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the trial
- •Clinically significant abnormal laboratory test results at screening
- •ECT treatment within the past two months
结局指标
主要结局
Positive and Negative Syndrome Scale (PANSS)
Hopkins Verbal Learning Test
Wisconsin Card Sorting Test (WCST)
Spatial working memory task
次要结局
- Neurocognitive training tasks
- Heinrichs-Carpenter Quality of Life Scale
- Functional assessments
研究者
Deepak C. D'Souza
Associate Professor of Psychiatry
Yale University