Efficacy Study of Panax Ginseng to Boost Antipsychotics Effects in Schizophrenia

Last updated: December 11, 2012
Sponsor: Lawson Health Research Institute
Overall Status: Completed

Phase

1/2

Condition

Dyskinesias

Tourette's Syndrome

Stress

Treatment

N/A

Clinical Study ID

NCT00401089
R-02-285
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female

  • age 18-65 years

  • DSM-IV diagnosis of Schizophrenia

  • SANS score greater than 30

Exclusion

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

Study Design

Total Participants: 60
Study Start date:
December 01, 2002
Estimated Completion Date:
October 31, 2007

Study 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.

Connect with a study center

  • Queen's University

    Kingston, Ontario
    Canada

    Site Not Available

  • Regional Mental Health Care London

    St. Thomas, Ontario N5P 3V9
    Canada

    Site Not Available

  • Northern Ontario Medical School

    Thunder Bay, Ontario
    Canada

    Site Not Available

  • Northwick Park Hospital

    Harrow, Middlesex HA13UJ
    United Kingdom

    Site Not Available

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