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.

Study Overview

• Status: Completed
• Conditions: Obesity; Schizophrenia; Schizoaffective Disorder; Insulin Resistance; Tardive Dyskinesia
• Intervention / Treatment: Drug: Panax Ginseng

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada
      • Queen's University
    • St. Thomas, Ontario, Canada, N5P 3V9
      • Regional Mental Health Care London
    • Thunder Bay, Ontario, Canada
      • Northern Ontario Medical School
• United Kingdom
  • Middlesex
    • Harrow, Middlesex, United Kingdom, HA13UJ
      • Northwick Park Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Ginsana-115

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuro-Cognitive Screening Test	The battery of neurocognitive tests is to be administered in a computerized format to the subjects at various time intervals	wk 0, 8, crossover , wk 2, 8
PANSS Positive Negative Syndrome Scale	Changes in PANSS is the co-primary outcome measure	-wk 2, wk 0, 2, 5,8 crossover wk 2,5,8
SANS	We list SANS as the co-primary outcome measure. We cross-validate the changes in SANS with PANSS	Change from baseline to week 8, cross-over; week 11-week 18.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HAM-D Hamilton Depression Rating Scale	We will correlate the changes in HAM-D with PANSS changes	-wk2, wk0, 2, 5, 8 crossover wk 2, 5, 8
BPRS Brief Psychiatric Rating Scale	This is a measure of the global change if any of the psychiatric symptoms during the 18-week period	-wk 2, wk 0, 2,5,8 crossover wk 2, 5, 8
QLS Quality of Life Scale		wk 0, 8 crossover wk 8
AIMS Abnormal Involuntary Movement Scale	We examined whether subjects experienced any changes in dyskinetic movements	-wk 2, wk 0, 2, 5, 8 crossover wk 2, 5, 8
SAS Simpson Angus Scale for Extrapyramidal Symptoms		-wk 2, wk 0, 2,5,8 crossover wk 2,5,8
Blood Chemistry Profile: CBC, kidney function,lipid profile, fasting glucose insulin	We examined whether the subjects participated in the study experienced any changes in indices of metabolic-metabolic functions	-wk 2, wk 8 crossover wk 8
BMI Body Mass index	BMI will be measured along with anthropometric measures: % total body water;% total fat, % muscle mass	Change from baseline to end of 18-week period

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: Imperial College London; Queen's University; Northern Ontario School of Medicine
• Investigators: Principal Investigator: Simon S Chiu, MD PhD, Lawson Health Research Institute London Ontario Canada

Study record dates

Study Major Dates

• Study Start: December 1, 2002
• Primary Completion (Actual): December 1, 2006
• Study Completion (Actual): October 1, 2007

Study Registration Dates

• First Submitted: November 15, 2006
• First Submitted That Met QC Criteria: November 16, 2006
• First Posted (Estimate): November 17, 2006

Study Record Updates

• Last Update Posted (Estimate): December 12, 2012
• Last Update Submitted That Met QC Criteria: December 11, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Atypical antipsychotics; negative symptoms schizophrenia; Neurocognition impairment; obesity risk factor; Diabetes insulin resistance schizophrenia
• Additional Relevant MeSH Terms: Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Schizophrenia Spectrum and Other Psychotic Disorders; Movement Disorders; Hyperinsulinism; Dyskinesia, Drug-Induced; Schizophrenia; Psychotic Disorders; Insulin Resistance; Dyskinesias; Tardive Dyskinesia
• Other Study ID Numbers: R-02-285