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Completed

NCT Number: NCT00401089

Efficacy Study of Panax Ginseng to Boost Antipsychotics Effects in Schizophrenia

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.

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Key information

Conditions

Schizophrenia Body Weight Central Nervous System Diseases Dyskinesia, Drug-Induced Dyskinesias Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Mental Disorders Metabolic Diseases Movement Disorders Nervous System Diseases Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms Tardive Dyskinesia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Queen's University, Kingston, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Ginsana-115

Primary outcomes

  1. Neuro-Cognitive Screening Test

    Time frame: 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

  2. PANSS Positive Negative Syndrome Scale

    Time frame: -wk 2, wk 0, 2, 5,8 crossover wk 2,5,8

    Changes in PANSS is the co-primary outcome measure

  3. SANS

    Time frame: 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 outcomes

  1. HAM-D Hamilton Depression Rating Scale

    Time frame: -wk2, wk0, 2, 5, 8 crossover wk 2, 5, 8

    We will correlate the changes in HAM-D with PANSS changes

  2. BPRS Brief Psychiatric Rating Scale

    Time frame: -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

  3. QLS Quality of Life Scale

    Time frame: wk 0, 8 crossover wk 8

  4. AIMS Abnormal Involuntary Movement Scale

    Time frame: -wk 2, wk 0, 2, 5, 8 crossover wk 2, 5, 8

    We examined whether subjects experienced any changes in dyskinetic movements

  5. SAS Simpson Angus Scale for Extrapyramidal Symptoms

    Time frame: -wk 2, wk 0, 2,5,8 crossover wk 2,5,8

  6. Blood Chemistry Profile: CBC, kidney function,lipid profile, fasting glucose insulin

    Time frame: -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

  7. BMI Body Mass index

    Time frame: Change from baseline to end of 18-week period

    BMI will be measured along with anthropometric measures: % total body water;% total fat, % muscle mass

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Collaborators

  • Imperial College London
  • Northern Ontario School of Medicine
  • Queen's University

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2006
Study completion
2007
First posted
Nov 17, 2006
Registry last updated
Dec 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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