Efficacy Study of Panax Ginseng to Boost Antipsychotics Effects in Schizophrenia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Placebo-controlled Cross Study of Panax Ginseng in Augmentation of Antipsychotics in 60 Partially Treatment Responsive Patients With Schizophrenia

Conditions
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Schizophrenia, Schizoaffective Disorder, Tardive Dyskinesia, Insulin Resistance, Obesity

Intervention / Treatment
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* Drug: Panax Ginseng


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female age 18-65 years DSM-IV diagnosis of Schizophrenia SANS score greater than 30 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ginsana-115<br>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. | Drug: Panax Ginseng<br>* The standardized extract of Panax Ginseng was formulated by Boehringer Ingelheim Pharmaton, Switzerland and fulfills the criteria of cGMP. Quality control and safety are monitored regularly by Boehringer Ingelheim Pharmaton.<br>* Other names: Ginsana-115;|
| Placebo Comparator: Sugar Pill<br>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 | Drug: Panax Ginseng<br>* The standardized extract of Panax Ginseng was formulated by Boehringer Ingelheim Pharmaton, Switzerland and fulfills the criteria of cGMP. Quality control and safety are monitored regularly by Boehringer Ingelheim Pharmaton.<br>* Other names: Ginsana-115;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuro-Cognitive Screening Test | The battery of neurocognitive tests is to be administered in a computerized format to the subjects at various time intervals | wk 0, 8, crossover , wk 2, 8 | 
| PANSS Positive Negative Syndrome Scale | Changes in PANSS is the co-primary outcome measure | -wk 2, wk 0, 2, 5,8 crossover wk 2,5,8 | 
| SANS | We list SANS as the co-primary outcome measure. We cross-validate the changes in SANS with PANSS | Change from baseline to week 8, cross-over; week 11-week 18. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAM-D Hamilton Depression Rating Scale | We will correlate the changes in HAM-D with PANSS changes | -wk2, wk0, 2, 5, 8 crossover wk 2, 5, 8 | 
| BPRS Brief Psychiatric Rating Scale | This is a measure of the global change if any of the psychiatric symptoms during the 18-week period | -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 | We examined whether subjects experienced any changes in dyskinetic movements | -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 | We examined whether the subjects participated in the study experienced any changes in indices of metabolic-metabolic functions | -wk 2, wk 8 crossover wk 8 | 
| BMI Body Mass index | BMI will be measured along with anthropometric measures: % total body water;% total fat, % muscle mass | Change from baseline to end of 18-week period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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negative symptoms schizophrenia, Atypical antipsychotics, Neurocognition impairment, obesity risk factor, Diabetes insulin resistance schizophrenia