Efficacy Study of Panax Ginseng to Boost Antipsychotics Effects in Schizophrenia

Phase 1

Completed

• Conditions: Schizophrenia; Schizoaffective Disorder; Tardive Dyskinesia; Insulin Resistance; Obesity
• Interventions: Drug: Panax Ginseng

• Registration Number: NCT00401089
• Lead Sponsor: Lawson Health Research Institute

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.

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 Timeline

• Study Start: 2002-12
• Study First Submitted: 2006-11-15
• Study First Submitted QC: 2006-11-16
• Study First Posted: 2006-11-17
• Primary Completion: 2006-12
• Study Completion: 2007-10
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-11
• Last Update Posted: 2012-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sugar Pill	Panax Ginseng	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
Ginsana-115	Panax Ginseng	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.

Primary Outcome Measures

Name	Time	Method
Neuro-Cognitive Screening Test	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
PANSS Positive Negative Syndrome Scale	-wk 2, wk 0, 2, 5,8 crossover wk 2,5,8	Changes in PANSS is the co-primary outcome measure
SANS	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

Name	Time	Method
HAM-D Hamilton Depression Rating Scale	-wk2, wk0, 2, 5, 8 crossover wk 2, 5, 8	We will correlate the changes in HAM-D with PANSS changes
BPRS Brief Psychiatric Rating Scale	-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
QLS Quality of Life Scale	wk 0, 8 crossover wk 8
AIMS Abnormal Involuntary Movement Scale	-wk 2, wk 0, 2, 5, 8 crossover wk 2, 5, 8	We examined whether subjects experienced any changes in dyskinetic movements
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	-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
BMI Body Mass index	Change from baseline to end of 18-week period	BMI will be measured along with anthropometric measures: % total body water;% total fat, % muscle mass

Trial Locations

Locations (4)

Regional Mental Health Care London; 🇨🇦 St. Thomas, Ontario, Canada

Queen's University; 🇨🇦 Kingston, Ontario, Canada

Northwick Park Hospital; 🇬🇧 Harrow, Middlesex, United Kingdom

Northern Ontario Medical School; 🇨🇦 Thunder Bay, Ontario, Canada