A Placebo-controlled Cross Study of Panax Ginseng in Augmentation of Antipsychotics in 60 Partially Treatment Responsive Patients With Schizophrenia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Neuro-Cognitive Screening Test
研究概览
简要总结
The objective of the study is to determine whether Panax Ginseng with multiple interactions with key components of brain signaling pathway, can augment the effects of antipsychotics in Schizophrenia. We are primarily interested to examine the actions of Ginseng combined with antipsychotics in improving the ways patients diagnosed with schizophrenia behave in social environment, store, process and retrieve information.
详细描述
Schizophrenia is a serious mental disorder affecting individuals in multiple ways: behavior control, emotional and information processing and the functional levels conforming to societal norms. Despite recent advances in medication therapy in treating the target symptoms of schizophrenia , subsets of patients diagnosed with schizophrenia continue to exhibit negative symptoms ( social withdrawal,apathy, lack of drive )and cognitive impairment (memory, attention, judgment and reasoning). Recently, there has been interest to explore the efficacy of avenue of dietary and herbal supplements with known pharmacological actions in treatment and prevention of neuropsychiatric disorders, especially bipolar and schizophrenia.
We hypothesize that Panax Ginseng , with multiple interactions with chemical pathways in the brain described as neurotransmitter systems (Dopamine, GABA and NMDA ) can improve the residual symptoms of schizophrenia when added to the antipsychotics currently used in the treatment of schizophrenia. Furthermore, in view of previous studies of Ginseng in enhancing memory , we hypothesize that the standardized formulation of Ginseng (Ginsana-115 from Boehringer Ingelheim-Pharmaton,Switzerland ) will optimize the antipsychotics in cognition impairment and negative symptoms. In the 18-week RCT cross-over study, schizophrenic subjects will be treated with either Ginsana-115 ( 100 mg or 200 mg by oral route) or placebo in a cross-over design. we plan to recruit 60 subjects diagnosed as schizophrenia from the four sites : London-St. Thomas, Ontario, Canada; Kingston Ontario Canada; Thunderbay, Ontario Canada and Middlesex, United Kingdom.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Male or female
- •age 18-65 years
- •DSM-IV diagnosis of Schizophrenia
- •SANS score greater than 30
排除标准
- •Current (past 12 months) substance use disorder
- •Except nicotine dependence
- •Major medical disorders : hematological disorder
- •Chronic active hepatitis, acute hepatitis, cirrhosis of liver, AIDS
- •Pregnancy and breast-feeding
- •Neurological disorders including epilepsy
- •traumatic brain injury
- •HAM-D score greater than 24
研究组 & 干预措施
Ginsana-115
Ginsana-115 (Panax Ginseng formulation obtained from Boehringer Ingelheim Pharmaton Inc. Switzerland )is available in oral dosage form of capsules. Two dosages of Ginsana-115 will be tested: 100 mg once daily oral dosage ( 1 100-mg Ginsana-115 capsule) and 200 mg once daily dosage ( 2 100-mg Ginsana-115 capsule). The total duration of each dosage is 8 weeks.
干预措施: Panax Ginseng (Drug)
Sugar Pill
Placebo capsules formulated identical to the active drug: Ginsana-115 are to be obtained from Boehringer Ingelheim Pharmaton, Switzerland. Two dosages of Placebo capsules will be administered once daily for 8 weeks : a) Placebo 100 mg capsule: 1 placebo capsule daily; b) Placebo 200 mg capsule: 2 placebo-capsule daily
干预措施: Panax Ginseng (Drug)
结局指标
主要结局
Neuro-Cognitive Screening Test
时间窗: wk 0, 8, crossover , wk 2, 8
The battery of neurocognitive tests is to be administered in a computerized format to the subjects at various time intervals
PANSS Positive Negative Syndrome Scale
时间窗: -wk 2, wk 0, 2, 5,8 crossover wk 2,5,8
Changes in PANSS is the co-primary outcome measure
SANS
时间窗: Change from baseline to week 8, cross-over; week 11-week 18.
We list SANS as the co-primary outcome measure. We cross-validate the changes in SANS with PANSS
次要结局
- HAM-D Hamilton Depression Rating Scale(-wk2, wk0, 2, 5, 8 crossover wk 2, 5, 8)
- BPRS Brief Psychiatric Rating Scale(-wk 2, wk 0, 2,5,8 crossover wk 2, 5, 8)
- QLS Quality of Life Scale(wk 0, 8 crossover wk 8)
- AIMS Abnormal Involuntary Movement Scale(-wk 2, wk 0, 2, 5, 8 crossover wk 2, 5, 8)
- SAS Simpson Angus Scale for Extrapyramidal Symptoms(-wk 2, wk 0, 2,5,8 crossover wk 2,5,8)
- Blood Chemistry Profile: CBC, kidney function,lipid profile, fasting glucose insulin(-wk 2, wk 8 crossover wk 8)
- BMI Body Mass index(Change from baseline to end of 18-week period)
研究者
Simon Chiu
University of Western Ontario London Ontario; Research Scientist, Lawson Health Research Institute London Ontario Canada
Lawson Health Research Institute
