DAAOI-1 Treatment for Treatment-resistant Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The severity of psychiatric symptoms
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 (particularly clozapine-resistant) 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-1, a D-amino acid oxidase (DAAO) inhibitor, is a NMDA-enhancing agents.
The aim of this project is to examine the effectiveness and safety of DAAOI-1 adjuvant treatment for clozapine-resistant refractory 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 (particularly clozapine-resistant) is still a difficult clinical issue at present. Among schizophrenia patients, around 20-25%are treatment-resistant. 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 (D-serine, D-alanine), and sarcosine (a glycine transporter I inhibitor), revealed beneficial but limited efficacy for positive and negative symptoms. The investigators recently started to study the potential of DAAOI-1, a D-amino acid oxidase (DAAO) inhibitor which can elevate synaptic concentration of D-amino acids.
The aims of this project is to examine the effectiveness and safety of DAAOI-1 adjuvant treatment for clozapine-resistant refractory 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
- Quadruple (Participant, Care Provider, 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
- •Fulfilled the DSM-IV criteria of schizophrenia
- •Poor responder of clozapine: a 12-week treatment without satisfactory response: a minimal total score of 70 on the Positive and Negative Syndrome Scale (PANSS) (Kay 1987), and a minimal total score of 40 on the Scale for the Assessment of Negative Symptoms (SANS) (Andreasen 1983).
- •Agree to participate in the study and provide informed consent
排除标准
- •Meet DSM-IV criteria of other AXIS I disorder, current substance dependence or mental retardation
- •Serious medical or neurological illness
- •Pregnancy or lactation
- •Use of depot antipsychotic in the past 6 months
- •Inability to follow protocol.
研究组 & 干预措施
starch pill
干预措施: placebo (Drug)
BE 1
DAAOI-1 1g
干预措施: DAAOI-1 (Drug)
BE 2
DAAOI-1 2g
干预措施: DAAOI-1 (Drug)
结局指标
主要结局
The severity of psychiatric symptoms
时间窗: week 0, 2, 4, 6
The severity of psychiatric symptoms will be assessed by: 1. Positive and Negative Syndrome Scale(PANSS) 2. Assessment of Negative symptoms(SANS) 3. Global assessment of function(GAF) 4. Quality of life scale(QOL)
次要结局
- Cognitive function(week 0, 6)
- PANSS subscales(week 0,2,4,6)
- Hamilton Depression Rating Scale (HAMD)(Week 0,2,4, 6)
研究者
Hsien-Yuan Lane
Departement of psychiatry, China Medical University Hospital
China Medical University Hospital