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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
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.
Queen's University
Kingston, Ontario, Canada
Regional Mental Health Care London
St. Thomas, Ontario, Canada
Northern Ontario Medical School
Thunder Bay, Ontario, Canada
Northwick Park Hospital
Harrow, Middlesex, United Kingdom
Neuro-Cognitive Screening Test
The battery of neurocognitive tests is to be administered in a computerized format to the subjects at various time intervals
Time frame: wk 0, 8, crossover , wk 2, 8
PANSS Positive Negative Syndrome Scale
Changes in PANSS is the co-primary outcome measure
Time frame: -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
Time frame: Change from baseline to week 8, cross-over; week 11-week 18.
HAM-D Hamilton Depression Rating Scale
We will correlate the changes in HAM-D with PANSS changes
Time frame: -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
Time frame: -wk 2, wk 0, 2,5,8 crossover wk 2, 5, 8
QLS Quality of Life Scale
Time frame: wk 0, 8 crossover wk 8
AIMS Abnormal Involuntary Movement Scale
We examined whether subjects experienced any changes in dyskinetic movements
Time frame: -wk 2, wk 0, 2, 5, 8 crossover wk 2, 5, 8
SAS Simpson Angus Scale for Extrapyramidal Symptoms
Time frame: -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
Time frame: -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
Time frame: Change from baseline to end of 18-week period
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