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Efficacy Study of Panax Ginseng to Boost Antipsychotics Effects in Schizophrenia

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Tardive Dyskinesia

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Panax Ginseng
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring negative symptoms schizophrenia, Atypical antipsychotics, Neurocognition impairment, obesity risk factor, Diabetes insulin resistance schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Queen's University
  • Regional Mental Health Care London
  • Northern Ontario Medical School
  • Northwick Park Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ginsana-115

Sugar Pill

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Neuro-Cognitive Screening Test
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
Changes in PANSS is the co-primary outcome measure
SANS
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
We will correlate the changes in HAM-D with PANSS changes
BPRS Brief Psychiatric Rating Scale
This is a measure of the global change if any of the psychiatric symptoms during the 18-week period
QLS Quality of Life Scale
AIMS Abnormal Involuntary Movement Scale
We examined whether subjects experienced any changes in dyskinetic movements
SAS Simpson Angus Scale for Extrapyramidal Symptoms
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
BMI Body Mass index
BMI will be measured along with anthropometric measures: % total body water;% total fat, % muscle mass

Full Information

First Posted
November 15, 2006
Last Updated
December 11, 2012
Sponsor
Lawson Health Research Institute
Collaborators
Queen's University, Northern Ontario School of Medicine, Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT00401089
Brief Title
Efficacy Study of Panax Ginseng to Boost Antipsychotics Effects in Schizophrenia
Official Title
A Placebo-controlled Cross Study of Panax Ginseng in Augmentation of Antipsychotics in 60 Partially Treatment Responsive Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Queen's University, Northern Ontario School of Medicine, Imperial College London

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Tardive Dyskinesia, Insulin Resistance, Obesity
Keywords
negative symptoms schizophrenia, Atypical antipsychotics, Neurocognition impairment, obesity risk factor, Diabetes insulin resistance schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ginsana-115
Arm Type
Experimental
Arm Description
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.
Arm Title
Sugar Pill
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Panax Ginseng
Other Intervention Name(s)
Ginsana-115
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neuro-Cognitive Screening Test
Description
The battery of neurocognitive tests is to be administered in a computerized format to the subjects at various time intervals
Time Frame
wk 0, 8, crossover , wk 2, 8
Title
PANSS Positive Negative Syndrome Scale
Description
Changes in PANSS is the co-primary outcome measure
Time Frame
-wk 2, wk 0, 2, 5,8 crossover wk 2,5,8
Title
SANS
Description
We list SANS as the co-primary outcome measure. We cross-validate the changes in SANS with PANSS
Time Frame
Change from baseline to week 8, cross-over; week 11-week 18.
Secondary Outcome Measure Information:
Title
HAM-D Hamilton Depression Rating Scale
Description
We will correlate the changes in HAM-D with PANSS changes
Time Frame
-wk2, wk0, 2, 5, 8 crossover wk 2, 5, 8
Title
BPRS Brief Psychiatric Rating Scale
Description
This is a measure of the global change if any of the psychiatric symptoms during the 18-week period
Time Frame
-wk 2, wk 0, 2,5,8 crossover wk 2, 5, 8
Title
QLS Quality of Life Scale
Time Frame
wk 0, 8 crossover wk 8
Title
AIMS Abnormal Involuntary Movement Scale
Description
We examined whether subjects experienced any changes in dyskinetic movements
Time Frame
-wk 2, wk 0, 2, 5, 8 crossover wk 2, 5, 8
Title
SAS Simpson Angus Scale for Extrapyramidal Symptoms
Time Frame
-wk 2, wk 0, 2,5,8 crossover wk 2,5,8
Title
Blood Chemistry Profile: CBC, kidney function,lipid profile, fasting glucose insulin
Description
We examined whether the subjects participated in the study experienced any changes in indices of metabolic-metabolic functions
Time Frame
-wk 2, wk 8 crossover wk 8
Title
BMI Body Mass index
Description
BMI will be measured along with anthropometric measures: % total body water;% total fat, % muscle mass
Time Frame
Change from baseline to end of 18-week period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon S Chiu, MD PhD
Organizational Affiliation
Lawson Health Research Institute London Ontario Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen's University
City
Kingston
State/Province
Ontario
Country
Canada
Facility Name
Regional Mental Health Care London
City
St. Thomas
State/Province
Ontario
ZIP/Postal Code
N5P 3V9
Country
Canada
Facility Name
Northern Ontario Medical School
City
Thunder Bay
State/Province
Ontario
Country
Canada
Facility Name
Northwick Park Hospital
City
Harrow
State/Province
Middlesex
ZIP/Postal Code
HA13UJ
Country
United Kingdom

12. IPD Sharing Statement

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Efficacy Study of Panax Ginseng to Boost Antipsychotics Effects in Schizophrenia

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