SchizophreniaPhase 1/2NCT00401089
Efficacy Study of Panax Ginseng to Boost Antipsychotics Effects in Schizophrenia
A Phase 1/2 study testing Panax Ginseng in people with Schizophrenia and Schizoaffective Disorder, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 4 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Tardive Dyskinesia
- What is being tested?
- Panax Ginseng
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Dec 2002to Oct 2007
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- age 18-65 years
- DSM-IV diagnosis of Schizophrenia
- SANS score greater than 30
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Canada3 sites
Queen's University
Kingston, Ontario
Regional Mental Health Care London
St. Thomas, Ontario, N5P 3V9
Northern Ontario Medical School
Thunder Bay, Ontario
About this study
Official title: A Placebo-controlled Cross Study of Panax Ginseng in Augmentation of Antipsychotics in 60 Partially Treatment Responsive Patients With Schizophrenia
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.
Read the 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.
- Being tested
- Panax Ginseng
- Keywords
- negative symptoms schizophrenia, Atypical antipsychotics, Neurocognition impairment, obesity risk factor, Diabetes insulin resistance schizophrenia
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Tardive Dyskinesia, Insulin Resistance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panax GinsengDrug
Also called Ginsana-115
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.
| Study group | Role | What they receive |
|---|---|---|
| Ginsana-115 | Experimental | 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. Receives: Drug: Panax Ginseng |
| Sugar Pill | Placebo comparator | 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 Receives: Drug: Panax Ginseng |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuro-Cognitive Screening Test
The battery of neurocognitive tests is to be administered in a computerized format to the subjects at various time intervals
Measured: wk 0, 8, crossover , wk 2, 8
PANSS Positive Negative Syndrome Scale
Changes in PANSS is the co-primary outcome measure
Measured: -wk 2, wk 0, 2, 5,8 crossover wk 2,5,8
SANS
We list SANS as the co-primary outcome measure. We cross-validate the changes in SANS with PANSS
Measured: Change from baseline to week 8, cross-over; week 11-week 18.
Secondary outcomes (7)
HAM-D Hamilton Depression Rating Scale
We will correlate the changes in HAM-D with PANSS changes
Measured: -wk2, wk0, 2, 5, 8 crossover wk 2, 5, 8
BPRS Brief Psychiatric Rating Scale
This is a measure of the global change if any of the psychiatric symptoms during the 18-week period
Measured: -wk 2, wk 0, 2,5,8 crossover wk 2, 5, 8
QLS Quality of Life Scale
Measured: wk 0, 8 crossover wk 8
AIMS Abnormal Involuntary Movement Scale
We examined whether subjects experienced any changes in dyskinetic movements
Measured: -wk 2, wk 0, 2, 5, 8 crossover wk 2, 5, 8
SAS Simpson Angus Scale for Extrapyramidal Symptoms
Measured: -wk 2, wk 0, 2,5,8 crossover wk 2,5,8
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
Measured: -wk 2, wk 8 crossover wk 8
BMI Body Mass index
BMI will be measured along with anthropometric measures: % total body water;% total fat, % muscle mass
Measured: Change from baseline to end of 18-week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2006 (estimated)
- Study startDec 2002
- Primary completionDec 2006
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Queen's University, Northern Ontario School of Medicine, Imperial College London
- Responsible party
- Principal investigator, Simon Chiu, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Simon S Chiu, MD PhD, Principal investigator, Lawson Health Research Institute London Ontario Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00401089
- Sponsor's protocol ID
- R-02-285
- Status last verified
- Dec 2012
- First submitted
- 15 Nov 2006
- Last updated
- 12 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled Cross Study of Panax Ginseng in Augmentation of Antipsychotics in 60 Partially Treatment Responsive Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT00401089
- Acronym / sponsor ID
- R-02-285
- Keywords
- negative symptoms schizophrenia, Atypical antipsychotics, Neurocognition impairment, obesity risk factor, Diabetes insulin resistance schizophrenia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Queen's University, Northern Ontario School of Medicine, Imperial College London
- Study start
- Dec 2002
- Primary completion
- Dec 2006 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 17 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ginsana-115 | Experimental | Drug: Panax GinsengGinsana-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. |
| Sugar Pill | Placebo comparator | Drug: Panax GinsengPlacebo 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female
- age 18-65 years
- DSM-IV diagnosis of Schizophrenia
- SANS score greater than 30
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Panax GinsengAlso: Ginsana-115The 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. | Drug | Ginsana-115, Sugar Pill |
Primary outcome
Neuro-Cognitive Screening Test
Time frame: 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
Time frame: -wk 2, wk 0, 2, 5,8 crossover wk 2,5,8
Changes in PANSS is the co-primary outcome measure
SANS
Time frame: 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
7 secondary outcomes
HAM-D Hamilton Depression Rating Scale
Time frame: -wk2, wk0, 2, 5, 8 crossover wk 2, 5, 8
BPRS Brief Psychiatric Rating Scale
Time frame: -wk 2, wk 0, 2,5,8 crossover wk 2, 5, 8
QLS Quality of Life Scale
Time frame: wk 0, 8 crossover wk 8
AIMS Abnormal Involuntary Movement Scale
Time frame: -wk 2, wk 0, 2, 5, 8 crossover wk 2, 5, 8
SAS Simpson Angus Scale for Extrapyramidal Symptoms
Time frame: -wk 2, wk 0, 2,5,8 crossover wk 2,5,8
Blood Chemistry Profile: CBC, kidney function,lipid profile, fasting glucose insulin
Time frame: -wk 2, wk 8 crossover wk 8
BMI Body Mass index
Time frame: Change from baseline to end of 18-week period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon S Chiu, MD PhD principal investigator
Lawson Health Research Institute London Ontario Canada
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Panax Ginseng in people with Schizophrenia and Schizoaffective Disorder, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuro-Cognitive Screening Test (time frame: wk 0, 8, crossover , wk 2, 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2012.