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Efficacy Study of Panax Ginseng to Boost Antipsychotics Effects in Schizophrenia

NCT ID: NCT00401089

Last Updated: 2012-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2007-10-31

Brief Summary

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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

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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.

Conditions

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Schizophrenia Schizoaffective Disorder Tardive Dyskinesia Insulin Resistance Obesity

Keywords

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negative symptoms schizophrenia Atypical antipsychotics Neurocognition impairment obesity risk factor Diabetes insulin resistance schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Panax Ginseng

Intervention Type DRUG

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.

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

Group Type PLACEBO_COMPARATOR

Panax Ginseng

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Ginsana-115

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen's University

OTHER

Sponsor Role collaborator

Northern Ontario School of Medicine

OTHER

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Simon Chiu

University of Western Ontario London Ontario; Research Scientist, Lawson Health Research Institute London Ontario Canada

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Simon S Chiu, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Lawson Health Research Institute London Ontario Canada

Locations

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Queen's University

Kingston, Ontario, Canada

Site Status

Regional Mental Health Care London

St. Thomas, Ontario, Canada

Site Status

Northern Ontario Medical School

Thunder Bay, Ontario, Canada

Site Status

Northwick Park Hospital

Harrow, Middlesex, United Kingdom

Site Status

Countries

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Canada United Kingdom

Other Identifiers

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R-02-285

Identifier Type: -

Identifier Source: org_study_id