Efficacy Study of Panax Ginseng to Boost Antipsychotics Effects in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder; Tardive Dyskinesia; Insulin Resistance; Obesity
MeSH terms: Dyskinesias; Tardive Dyskinesia; Insulin Resistance; Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Intervention name(s): Panax Ginseng
Intervention type(s): Drug
Intervention description(s): 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.
Other intervention name(s): Ginsana-115
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: negative symptoms schizophrenia; Atypical antipsychotics; Neurocognition impairment; obesity risk factor; Diabetes insulin resistance schizophrenia