DAAOI-2 add-on Treatment for Treatment-resistant Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Positive and Negative Syndrome Scale(PANSS)
研究概览
简要总结
Pharmacotherapy for schizophrenia has limitations such as residual positive and negative symptoms, cognitive deficits and intolerable side effects. Refractory schizophrenia is still a difficult clinical issue at present. According to the N-methyl-D-aspartate (NMDA) hypothesis, adjuvant NMDA-enhancing agents may have therapeutic benefit. DAAOI-2, a D-amino acid oxidase (DAAO) inhibitor, is a NMDA-enhancing agent. The aim of this project is to examine the effectiveness and safety of DAAOI-2 add-on treatment for treatment-resistant schizophrenia patients in a randomized, double-blind, placebo-controlled trial.
详细描述
Pharmacotherapy for schizophrenia has limitations such as residual positive and negative symptoms, cognitive deficits and intolerable side effects. Refractory schizophrenia is still a difficult clinical issue at present. According to the N-methyl-D-aspartate (NMDA) hypothesis, many clinical trials on NMDA-enhancing agents were studied. Adjuvant NMDA-enhancing agents, including glycine, D-amino acids such as D-serine, and sarcosine (a glycine transporter I inhibitor), revealed beneficial but limited efficacy for positive and negative symptoms.
The aim of this project is to examine the effectiveness and safety of DAAOI-2 add-on treatment for treatment resistant schizophrenia patients in a randomized, double-blind, placebo - controlled trial.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Fulfill the DSM-IV criteria of schizophrenia
- •Treatment resistant: No satisfactory response to at least two kinds of antipsychotics
- •Remain symptomatic but without clinically significant fluctuation and the antipsychotic doses are unchanged for at least 3 months
- •Have a minimum baseline total score of 70 on the Positive and Negative Syndrome Scale (PANSS)
- •Agree to participate in the study and provide informed consent
排除标准
- •Meet DSM-IV criteria of substance (including alcohol) abuse or dependence
- •Meet DSM-IV criteria of mental retardation
- •Serious medical or neurological illness
- •Pregnancy or lactation
- •Inability to follow protocol
研究组 & 干预措施
DAAOI-2
DAAOI-2: 500-2000mg/d
干预措施: DAAOI-2 (Drug)
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Positive and Negative Syndrome Scale(PANSS)
时间窗: 6 weeks after the trial (The end of the trial)
Assessment of Negative symptoms(SANS)
时间窗: 6 weeks after the trial (The end of the trial)
次要结局
- Clinical Global Impression (CGI)(6 weeks after the trial (The end of the trial))
- Quality of life scale (QOL)(6 weeks after the trial (The end of the trial))
- Hamilton Depression Rating Scale (HAMD)(6 weeks after the trial (The end of the trial))
- "Measurement and Treatment Research to Improve Cognition in Schizophrenia [MATRICS](6 weeks after the trial (The end of the trial))
- Global assessment of function (GAF)(6 weeks after the trial (The end of the trial))
- PANSS subscales(6 weeks after the trial (The end of the trial))
研究者
Hsien-Yuan Lane
Department of Psychiatry
China Medical University Hospital