Efficacy Study of Panax Ginseng to Boost Antipsychotics Effects in Schizophrenia - Full Text View

Purpose

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	Intervention	Phase
Schizophrenia Schizoaffective Disorder Tardive Dyskinesia Insulin Resistance Obesity	Drug: Panax Ginseng	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Genetics Home Reference related topics: schizophrenia

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Enrollment:	60
Study Start Date:	December 2002
Study Completion Date:	October 2007
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Genders Eligible for Study:	Both
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

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Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	November 15, 2006
Last Updated:	December 11, 2012
Health Authority:	Canada: Ethics Review Committee

Keywords provided by 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 Movement Disorders Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases	Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs

ClinicalTrials.gov processed this record on September 28, 2016