Efficacy Study of Panax Ginseng to Boost Antipsychotics Effects in Schizophrenia

• Neuro-Cognitive Screening Test [ Time Frame: wk 0, 8, crossover , wk 2, 8 ] [ Designated as safety issue: No ]
  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 [ Time Frame: -wk 2, wk 0, 2, 5,8 crossover wk 2,5,8 ] [ Designated as safety issue: No ]
  Changes in PANSS is the co-primary outcome measure
  
  
• SANS [ Time Frame: Change from baseline to week 8, cross-over; week 11-week 18. ] [ Designated as safety issue: No ]
  We list SANS as the co-primary outcome measure. We cross-validate the changes in SANS with PANSS
  
  

• HAM-D Hamilton Depression Rating Scale [ Time Frame: -wk2, wk0, 2, 5, 8 crossover wk 2, 5, 8 ] [ Designated as safety issue: No ]
  We will correlate the changes in HAM-D with PANSS changes
  
  
• BPRS Brief Psychiatric Rating Scale [ Time Frame: -wk 2, wk 0, 2,5,8 crossover wk 2, 5, 8 ] [ Designated as safety issue: No ]
  This is a measure of the global change if any of the psychiatric symptoms during the 18-week period
  
  
• QLS Quality of Life Scale [ Time Frame: wk 0, 8 crossover wk 8 ] [ Designated as safety issue: No ]
  
• AIMS Abnormal Involuntary Movement Scale [ Time Frame: -wk 2, wk 0, 2, 5, 8 crossover wk 2, 5, 8 ] [ Designated as safety issue: Yes ]
  We examined whether subjects experienced any changes in dyskinetic movements
  
  
• SAS Simpson Angus Scale for Extrapyramidal Symptoms [ Time Frame: -wk 2, wk 0, 2,5,8 crossover wk 2,5,8 ] [ Designated as safety issue: Yes ]
  
• Blood Chemistry Profile: CBC, kidney function,lipid profile, fasting glucose insulin [ Time Frame: -wk 2, wk 8 crossover wk 8 ] [ Designated as safety issue: Yes ]
  We examined whether the subjects participated in the study experienced any changes in indices of metabolic-metabolic functions
  
  
• BMI Body Mass index [ Time Frame: Change from baseline to end of 18-week period ] [ Designated as safety issue: Yes ]
  BMI will be measured along with anthropometric measures: % total body water;% total fat, % muscle mass
  
  

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.