A Double-Blind, Randomized, Placebo-Controlled Trial of Artemisinin as an Add-on Therapy to Risperidone in the Treatment of Drug-Naive First-Episode Patients With Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- the Positive and Negative Syndrome Scale (PANSS)
研究概览
简要总结
This study will determine the effectiveness of artemisinin plus risperidone in improving symptoms and cognitive disturbances and in Chinese people with schizophrenia. The study addresses the Toxoplasma infection hypothesis of schizophrenia.
详细描述
Evidences of high levels of Toxoplasma gondii antibodies in the serum and the cerebrospinal fluid (CSF) of individuals with schizophrenia have suggested that this organism might be involved in the etiopathogenesis of schizophrenia. The investigators hypothesize that antimicrobial therapy by using an add-on agent together with a well-proven neuroleptic may have favorable effects on a subgroup of schizophrenic patients.
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 (Participant, Investigator)
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
- •Currently resides in Beijing, China
- •Diagnosis of schizophrenia or schizophreniform disorder
- •Duration of symptoms is no longer than 60 months
- •No history of treatment with antipsychotic medication or, if previously treated, a total lifetime usage of less than 14 days
- •Current psychotic symptoms are of moderate severity or greater as measured by one of the five psychotic items in the Brief Psychiatric Rating Scale (BPRS)
排除标准
- •DSM-IV Axis I diagnosis other than schizophrenia or schizophreniform psychosis
- •Documented disease of the central nervous system that might interfere with the trial assessments (e.g., stroke, tumor, Parkinson's disease, Huntington's disease, seizure disorder, history of brain trauma resulting in significant impairment, chronic infection)
- •Acute, unstable, and/or significant and untreated medical illness (e.g., infection, unstable diabetes, uncontrolled hypertension)
- •A clinically significant echocardiogram (ECG) abnormality in the opinion of the investigator
- •Pregnant or breastfeeding
- •Use of prohibited concomitant therapy
- •History of severe allergy or hypersensitivity
- •Dependence on alcohol or illegal drugs
- •Use of any of the following medications during the trial: antipsychotic medications other than risperidone; psychostimulants; or antidepressants
研究组 & 干预措施
Artemisinin, anti-toxoplasma
Artemisinin
干预措施: Artemisinin (Drug)
Placebo
Placebo looks like the active drug, with the same dose.
干预措施: Placebo (Other)
结局指标
主要结局
the Positive and Negative Syndrome Scale (PANSS)
时间窗: 10 weeks
次要结局
- the Simpson-Angus Scale for extrapyramidal side effects (SAS)(10 weeks)
- The Abnormal Involuntary Movement Scale (AIMS)(10 weeks)
- the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)(10 weeks)
- the Clinical Global Impression (ICG)(10 weeks)
- UKU Side Effect Rating Scale(10 weeks)
研究者
Xiang Yang Zhang
Director, the Research Center
Beijing HuiLongGuan Hospital