Schizophrenia, Schizoaffective Disorder, Tardive Dyskinesia, Insulin Resistance, Obesity
Conditions
Keywords
negative symptoms schizophrenia, Atypical antipsychotics, Neurocognition impairment, obesity risk factor, Diabetes insulin resistance schizophrenia
Brief summary
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
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.
Interventions
DRUGPanax Ginseng
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.
Sponsors
Queen's University
Northern Ontario School of Medicine
Imperial College London
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neuro-Cognitive Screening Test | 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 | -wk 2, wk 0, 2, 5,8 crossover wk 2,5,8 | Changes in PANSS is the co-primary outcome measure |
| SANS | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AIMS Abnormal Involuntary Movement Scale | -wk 2, wk 0, 2, 5, 8 crossover wk 2, 5, 8 | We examined whether subjects experienced any changes in dyskinetic movements |
| SAS Simpson Angus Scale for Extrapyramidal Symptoms | -wk 2, wk 0, 2,5,8 crossover wk 2,5,8 | — |
| HAM-D Hamilton Depression Rating Scale | -wk2, wk0, 2, 5, 8 crossover wk 2, 5, 8 | We will correlate the changes in HAM-D with PANSS changes |
| BMI Body Mass index | Change from baseline to end of 18-week period | BMI will be measured along with anthropometric measures: % total body water;% total fat, % muscle mass |
| Blood Chemistry Profile: CBC, kidney function,lipid profile, fasting glucose insulin | -wk 2, wk 8 crossover wk 8 | We examined whether the subjects participated in the study experienced any changes in indices of metabolic-metabolic functions |
| BPRS Brief Psychiatric Rating Scale | -wk 2, wk 0, 2,5,8 crossover wk 2, 5, 8 | This is a measure of the global change if any of the psychiatric symptoms during the 18-week period |
| QLS Quality of Life Scale | wk 0, 8 crossover wk 8 | — |
Countries
Canada, United Kingdom
Outcome results
None listed