NCT00138775Unknown2 期
D-Serine Adjuvant Pharmacotherapy for the Treatment of Schizophrenia
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 试验地点
- 19
- 主要终点
- SANS - Scale for the Assessment of Negative Symptoms - weeks 0, 8 and 16
研究概览
简要总结
The goal of the present study is to evaluate the effect of D-serine, added to antipsychotic treatment, on negative and cognitive symptoms in schizophrenia.
The investigators are hypothesizing that D-serine will improve cognitive functioning and negative symptoms.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) diagnosis of schizophrenia and\or schizoaffective disorder.
- •Age between 18 to
- •PANSS negative symptom score higher than
- •SAS total score lower than
- •CDSS suicidal risk lower than 2
排除标准
- •Meets DSM-IV criteria for mental retardation.
- •Medical condition which confounds presentation or treatment (e.g. uncontrolled diabetes mellitus, history of kidney stones, acute drug toxicity, dementia, delirium, stroke, etc.)
- •Meets DSM-IV criteria for alcohol or drug dependence in last 6 months.
- •Meets DSM-IV criteria for alcohol or drug abuse in last one month.
- •Treatment with clozapine.
- •Current positive pregnancy test or not using acceptable method of birth control.
- •Meets DSM-IV criteria for current anxiety or mood disorders
结局指标
主要结局
SANS - Scale for the Assessment of Negative Symptoms - weeks 0, 8 and 16
Measurement and Treatment Research for Cognition in Schizophrenia (MATRICS) battery - visit weeks 0, 8 and 16
次要结局
- Positive and Negative Syndrome Scale of Schizophrenia (PANSS) positive, negative, general and total score - weeks 0, 8 and 16
- Simpson-Angus Scale (SAS) total score - weeks 0, 8 and 16
- Clinical Global Impressions (CGI) score - weeks 0, 8 and 16
- Calgary Depression Scale for Schizophrenia (CDSS) score - weeks 0, 8 and 16
- Side effect check list
研究者
研究点 (19)
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