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| Name | Class |
|---|---|
| Queen's University | OTHER |
| Northern Ontario School of Medicine | OTHER |
| Imperial College London | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ginsana-115 | Experimental | 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. |
|
| Sugar Pill | Placebo Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panax Ginseng | Drug | 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. |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simon S Chiu, MD PhD | Lawson Health Research Institute London Ontario Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen's University | Kingston | Ontario | Canada | |||
| Regional Mental Health Care London |
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|
| -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 |
| St. Thomas |
| Ontario |
| N5P 3V9 |
| Canada |
| Northern Ontario Medical School | Thunder Bay | Ontario | Canada |
| Northwick Park Hospital | Harrow | Middlesex | HA13UJ | United Kingdom |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D000071057 | Tardive Dyskinesia |
| D007333 | Insulin Resistance |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D004409 | Dyskinesia, Drug-Induced |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| C000713447 | Asian ginseng |
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