Phase 4 Study of Efficacy and Safety of Tandospirone Combined With Atypical Antipsychotic Drugs to Improve Cognitive Function in Schizophrenia
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Measurement and treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery(MCCB) total score
研究概览
简要总结
Efficacy and safety of Tandospirone combined with Atypical Antipsychotic drugs to Improve Cognitive function in Schizophrenia
详细描述
With atypical antipsychotics for the control group, evaluate cognitive function in schizophrenia patients with antipsychotics combined 5-Hydroxytryptamine 1A (5-HT1A) receptor partial agonist tandospirone
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
- Single (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
- •Diagnostic and Statistical Manual of Mental Disorders-IV Edition (DSM-IV) diagnostic criteria for schizophrenia patients.
- •18-65 years (including 18 and 65), male or female.
- •Treated with a stable dose of an AAPD for at least three months.
- •Informed consent was obtained (if the patient is in the acute phase of schizophrenia, does not have the capacity, their guardians need sign informed consent).
- •PANSS negative score ≤60.
排除标准
- •Combined AxisⅠmental illness other than schizophrenia;
- •Taking a mood stabilizer, antidepressants, anticholinergic or anxiolytic drugs, and other drugs improve cognitive function;
- •Suicidal tendencies;
- •Have severe or unstable heart, liver, kidney, endocrine, blood and other medical disease patients
- •Clinically significant ECG or laboratory abnormalities were
- •Glaucoma and epilepsy;
- •Unsupervised or unable to take prescribed medication;
- •History of alcohol and drug abuse;
- •Allergic;
- •Pregnant or lactating woman;
- •Patients participate in other clinical trials during a month;
研究组 & 干预措施
Control Group
Treated with a stable dose of an AAPD for at least three months before enrollment; Atypical antipsychotic drugs(AAPDs): Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole
干预措施: Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole (Drug)
Study Group
Atypical antipsychotic drugs(AAPDs) and Tandospirone ; Atypical antipsychotic drugs(AAPDs) ,treated with a stable dose of an AAPD for at least three months before enrollment; AAPD: Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole; Tandospirone, 30mg per day;
干预措施: Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole (Drug)
Study Group
Atypical antipsychotic drugs(AAPDs) and Tandospirone ; Atypical antipsychotic drugs(AAPDs) ,treated with a stable dose of an AAPD for at least three months before enrollment; AAPD: Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole; Tandospirone, 30mg per day;
干预措施: Tandospirone (Drug)
结局指标
主要结局
Measurement and treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery(MCCB) total score
时间窗: From baseline to 12 weeks of treatment
次要结局
- MATRICS Consensus Cognitive Battery(MCCB) factor score(From baseline to 12 weeks of treatment)
- Personal and Social Performance Scale(PSP) total score(From baseline to 12 weeks of treatment)
- Treatment Emergent Symptom Scale(TESS) factor score(From baseline to 12 weeks of treatment)
- Functional magnetic resonance imaging(FMRI)(From baseline to 12 weeks of treatment)
- Positive and Negative Syndrome Scale(PANSS) total score(From baseline to 12 weeks of treatment)
- Positive and Negative Syndrome Scale(PANSS) factor score(From baseline to 12 weeks of treatment)
- Clinical Global Impression(CGI) factor score(From baseline to 12 weeks of treatment)
研究者
Qingyun Yin
Professor
Guangzhou Psychiatric Hospital