Efficacy Study of Panax Ginseng to Boost Antipsychotics Effects in Schizophrenia

This study has been completed.
Sponsor:
Collaborators:
Queen's University
Northern Ontario School of Medicine
Imperial College London
Information provided by (Responsible Party):
Simon Chiu, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00401089
First received: November 15, 2006
Last updated: December 11, 2012
Last verified: December 2012

November 15, 2006
December 11, 2012
December 2002
December 2006   (final data collection date for primary outcome measure)
  • Neuro-Cognitive Screening Test [ Time Frame: wk 0, 8, crossover , wk 2, 8 ] [ Designated as safety issue: No ]
    The battery of neurocognitive tests is to be administered in a computerized format to the subjects at various time intervals
  • PANSS Positive Negative Syndrome Scale [ Time Frame: -wk 2, wk 0, 2, 5,8 crossover wk 2,5,8 ] [ Designated as safety issue: No ]
    Changes in PANSS is the co-primary outcome measure
  • SANS [ Time Frame: Change from baseline to week 8, cross-over; week 11-week 18. ] [ Designated as safety issue: No ]
    We list SANS as the co-primary outcome measure. We cross-validate the changes in SANS with PANSS
  • Neuro-Cognitive Screening Test
  • PANSS Positive Negative Syndrome Scale
  • SANS Scale for Assessment of Negative Symptoms
  • Treatment Emergent Adverse Events
Complete list of historical versions of study NCT00401089 on ClinicalTrials.gov Archive Site
  • HAM-D Hamilton Depression Rating Scale [ Time Frame: -wk2, wk0, 2, 5, 8 crossover wk 2, 5, 8 ] [ Designated as safety issue: No ]
    We will correlate the changes in HAM-D with PANSS changes
  • BPRS Brief Psychiatric Rating Scale [ Time Frame: -wk 2, wk 0, 2,5,8 crossover wk 2, 5, 8 ] [ Designated as safety issue: No ]
    This is a measure of the global change if any of the psychiatric symptoms during the 18-week period
  • QLS Quality of Life Scale [ Time Frame: wk 0, 8 crossover wk 8 ] [ Designated as safety issue: No ]
  • AIMS Abnormal Involuntary Movement Scale [ Time Frame: -wk 2, wk 0, 2, 5, 8 crossover wk 2, 5, 8 ] [ Designated as safety issue: Yes ]
    We examined whether subjects experienced any changes in dyskinetic movements
  • SAS Simpson Angus Scale for Extrapyramidal Symptoms [ Time Frame: -wk 2, wk 0, 2,5,8 crossover wk 2,5,8 ] [ Designated as safety issue: Yes ]
  • Blood Chemistry Profile: CBC, kidney function,lipid profile, fasting glucose insulin [ Time Frame: -wk 2, wk 8 crossover wk 8 ] [ Designated as safety issue: Yes ]
    We examined whether the subjects participated in the study experienced any changes in indices of metabolic-metabolic functions
  • BMI Body Mass index [ Time Frame: Change from baseline to end of 18-week period ] [ Designated as safety issue: Yes ]
    BMI will be measured along with anthropometric measures: % total body water;% total fat, % muscle mass
  • HAM-D Hamilton Depression Rating Scale
  • BPRS Brief Psychiatric Rating Scale
  • QLS Quality of Life Scale
  • AIMS Abnormal Involuntary Movement Scale
  • SAS Simpson Angus Scale for Extrapyramidal Symptoms
  • Blood Chemistry lipid glucose insulin
  • BMI Body Mass index
Not Provided
Not Provided
 
Efficacy Study of Panax Ginseng to Boost Antipsychotics Effects in Schizophrenia
A Placebo-controlled Cross Study of Panax Ginseng in Augmentation of Antipsychotics in 60 Partially Treatment Responsive Patients With 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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Schizophrenia
  • Schizoaffective Disorder
  • Tardive Dyskinesia
  • Insulin Resistance
  • Obesity
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
  • 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.
    Intervention: Drug: Panax Ginseng
  • 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
    Intervention: Drug: Panax Ginseng
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
October 2007
December 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United Kingdom
 
NCT00401089
R-02-285
Yes
Simon Chiu, Lawson Health Research Institute
Lawson Health Research Institute
  • Queen's University
  • Northern Ontario School of Medicine
  • Imperial College London
Principal Investigator: Simon S Chiu, MD PhD Lawson Health Research Institute London Ontario Canada
Lawson Health Research Institute
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP