A Double-blind and Randomized Trial of Ginkgo Biloba Extract Added to Risperidone in Treatment-naive First-episode Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- PANSS
研究概览
简要总结
A double-blind, randomized, placebo-controlled trial of ginkgo biloba extract (Egb-761) as an add-on therapy to risperidone compared to risperidone plus placebo in the treatment of 200 treatment-naive first-episode patients with schizophrenia. The study addresses an immune dysfunction hypothesis of schizophrenia.
详细描述
OBJECTIVE: There is evidence that an excessive free radical production or oxidative stress may be involved in the pathophysiology of patients with schizophrenia. The investigators hypothesize that antioxidant therapy by using an add-on agent together with a well-proven antipsychotic drug may have favorable effects on some schizophrenic patients.
METHODS:
- Clinical Trial: This is a randomized, double-blind and parallel controlled trial in treatment-naive first-episode patients with schizophrenia. The study consists of a 1-week stabilization phase, followed by 10 weeks of double-blind treatment. The total trial duration is 11 weeks.
- Medications: Eligible patients are randomly assigned to either capsulized EGb(240mg.day) or identically capsulized placebo addition to the risperidone (2-6mg/day) in a double-blind fashion.
- Assessment Procedures:
3.1. Primary Outcome Variable-psychopathology: Assessment instruments include the Positive and Negative Syndrome Scale (PANSS), and the Clinical Global Impression (CGI). Patients are interviewed at screening, at baseline and at every two weeks.
3.2. Cognitive tests: A comprehensive battery of tests encompassing the cognitive domains of executive function, attention, memory, perception, and general intellect is administered twice at baseline and at the end of 10-week treatment by a trained psychologist. Scoring follows standardized procedures.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of schizophrenia or schizophreniform disorder;
- •Duration of symptoms not longer than 60 months;
- •No prior treatment with antipsychotic medication or, if previously treated, a total lifetime usage of less than 14 days;
- •Between 16 and 40 years of age; and
- •Current psychotic symptoms of moderate severity.
排除标准
- •A DSM-IV Axis I diagnosis other than schizophrenia or schizophreniform;
- •Documented disease of the central nervous system that can interfere with the trial assessments including, but not limited to 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 ECG abnormality in the opinion of the investigator;
- •Pregnant or breast-feeding female;
- •Use of disallowed concomitant therapy;
- •History of severe allergy or hypersensitivity.
研究组 & 干预措施
Ginkgo biloba extract, antioxidant
Active treatment with Ginkgo biloba extract
干预措施: Ginkgo biloba extract (Drug)
Placebo
Treatment with placebo
干预措施: Placebo (Drug)
结局指标
主要结局
PANSS
时间窗: 11 weeks
PANSS
次要结局
- CGI(11 weeks)
- Cognition(11 weeks)
研究者
Xiang Yang Zhang
co-Director, Psychiatric Research Center
Beijing HuiLongGuan Hospital