Efficacy Study of Panax Ginseng to Boost Antipsychotics Effects in Schizophrenia

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Brief Title

Efficacy Study of Panax Ginseng to Boost Antipsychotics Effects in Schizophrenia

Official Title

A Placebo-controlled Cross Study of Panax Ginseng in Augmentation of Antipsychotics in 60 Partially Treatment Responsive Patients With 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.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Neuro-Cognitive Screening Test

Secondary Outcome

 HAM-D Hamilton Depression Rating Scale

Condition

Schizophrenia

Intervention

Panax Ginseng

Study Arms / Comparison Groups

 Ginsana-115
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

60

Start Date

December 2002

Completion Date

October 2007

Primary Completion Date

December 2006

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Simon S Chiu, MD PhD, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT00401089

Organization ID

R-02-285


Responsible Party

Principal Investigator

Study Sponsor

Lawson Health Research Institute

Collaborators

 Queen's University

Study Sponsor

Simon S Chiu, MD PhD, Principal Investigator, Lawson Health Research Institute London Ontario Canada


Verification Date

December 2012