Efficacy Study of Panax Ginseng to Boost Antipsychotics Effects in Schizophrenia

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00401089
• Other study ID #: R-02-285
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 15, 2006
• Last updated: December 11, 2012
• Start date: December 2002
• Est. completion date: October 2007

Study information

• Verified date: December 2012
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyskinesias
• Insulin Resistance
• Obesity
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Tardive Dyskinesia

Intervention

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.

Locations

Country	Name	City	State
Canada	Queen's University	Kingston	Ontario
Canada	Regional Mental Health Care London	St. Thomas	Ontario
Canada	Northern Ontario Medical School	Thunder Bay	Ontario
United Kingdom	Northwick Park Hospital	Harrow	Middlesex

Sponsors (4)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Imperial College London, Northern Ontario School of Medicine, Queen's University

Countries where clinical trial is conducted

Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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.	No
Secondary	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	No
Secondary	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	No
Secondary	QLS Quality of Life Scale		wk 0, 8 crossover wk 8	No
Secondary	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	Yes
Secondary	SAS Simpson Angus Scale for Extrapyramidal Symptoms		-wk 2, wk 0, 2,5,8 crossover wk 2,5,8	Yes
Secondary	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	Yes
Secondary	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	Yes