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Efficacy Study of Panax Ginseng to Boost Antipsychotics Effects in Schizophrenia

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ClinicalTrials.gov Identifier: NCT00401089
Recruitment Status : Completed
First Posted : November 17, 2006
Last Update Posted : December 12, 2012
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Tardive Dyskinesia Insulin Resistance Obesity Drug: Panax Ginseng Phase 1 Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Placebo-controlled Cross Study of Panax Ginseng in Augmentation of Antipsychotics in 60 Partially Treatment Responsive Patients With Schizophrenia
Study Start Date : December 2002
Primary Completion Date : December 2006
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Ginsana-115
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.
Drug: Panax 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.
Other Name: Ginsana-115
Placebo Comparator: Sugar Pill
Placebo capsules formulated identical to the active drug: Ginsana-115 are to be obtained from Boehringer Ingelheim Pharmaton, Switzerland. Two dosages of Placebo capsules will be administered once daily for 8 weeks : a) Placebo 100 mg capsule: 1 placebo capsule daily; b) Placebo 200 mg capsule: 2 placebo-capsule daily
Drug: Panax 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.
Other Name: Ginsana-115


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00401089


Locations
Canada, Ontario
Queen's University
Kingston, Ontario, Canada
Regional Mental Health Care London
St. Thomas, Ontario, Canada, N5P 3V9
Northern Ontario Medical School
Thunder Bay, Ontario, Canada
United Kingdom
Northwick Park Hospital
Harrow, Middlesex, United Kingdom, HA13UJ
Sponsors and Collaborators
Lawson Health Research Institute
Queen's University
Northern Ontario School of Medicine
Imperial College London
Investigators
Principal Investigator: Simon S Chiu, MD PhD Lawson Health Research Institute London Ontario Canada
More Information

Responsible Party: Simon Chiu, University of Western Ontario London Ontario; Research Scientist, Lawson Health Research Institute London Ontario Canada, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00401089     History of Changes
Other Study ID Numbers: R-02-285
First Posted: November 17, 2006    Key Record Dates
Last Update Posted: December 12, 2012
Last Verified: December 2012

Keywords provided by Simon Chiu, Lawson Health Research Institute:
negative symptoms schizophrenia
Atypical antipsychotics
Neurocognition impairment
obesity risk factor
Diabetes insulin resistance schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Insulin Resistance
Psychotic Disorders
Dyskinesias
Tardive Dyskinesia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Dyskinesia, Drug-Induced
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs