Efficacy Study of Panax Ginseng to Boost Antipsychotics Effects in Schizophrenia

• ClinicalTrials.gov Identifier: NCT00401089
• Recruitment Status: Completed
• First Posted: November 17, 2006
• Last Update Posted: December 12, 2012
• Sponsor: Lawson Health Research Institute
• Collaborators: Queen's University; Northern Ontario School of Medicine; Imperial College London
• Information provided by (Responsible Party): Simon Chiu, Lawson Health Research Institute

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.

Condition or disease	Intervention/treatment	Phase
Schizophrenia; Schizoaffective Disorder; Tardive Dyskinesia; Insulin Resistance; Obesity	Drug: Panax Ginseng	Phase 1; Phase 2

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Placebo-controlled Cross Study of Panax Ginseng in Augmentation of Antipsychotics in 60 Partially Treatment Responsive Patients With Schizophrenia
• Study Start Date: December 2002
• Actual Primary Completion Date: December 2006
• Actual Study Completion Date: October 2007

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	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.; Other Name: Ginsana-115
Placebo Comparator: 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	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.; Other Name: Ginsana-115

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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
3. 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

Secondary Outcome Measures :

1. HAM-D Hamilton Depression Rating Scale [ Time Frame: -wk2, wk0, 2, 5, 8 crossover wk 2, 5, 8 ]
   We will correlate the changes in HAM-D with PANSS changes
2. BPRS Brief Psychiatric Rating Scale [ Time Frame: -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
3. QLS Quality of Life Scale [ Time Frame: wk 0, 8 crossover wk 8 ]
4. AIMS Abnormal Involuntary Movement Scale [ Time Frame: -wk 2, wk 0, 2, 5, 8 crossover wk 2, 5, 8 ]
   We examined whether subjects experienced any changes in dyskinetic movements
5. SAS Simpson Angus Scale for Extrapyramidal Symptoms [ Time Frame: -wk 2, wk 0, 2,5,8 crossover wk 2,5,8 ]
6. Blood Chemistry Profile: CBC, kidney function,lipid profile, fasting glucose insulin [ Time Frame: -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
7. BMI Body Mass index [ Time Frame: Change from baseline to end of 18-week period ]
   BMI will be measured along with anthropometric measures: % total body water;% total fat, % muscle mass

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Canada, Ontario

Queen's University

Kingston, Ontario, Canada

Regional Mental Health Care London

St. Thomas, Ontario, Canada, N5P 3V9

Northern Ontario Medical School

Thunder Bay, Ontario, Canada

United Kingdom

Northwick Park Hospital

Harrow, Middlesex, United Kingdom, HA13UJ

Sponsors and Collaborators

Lawson Health Research Institute

Queen's University

Northern Ontario School of Medicine

Imperial College London

Investigators

• Principal Investigator: Simon S Chiu, MD PhD; Lawson Health Research Institute London Ontario Canada

More Information

• Responsible Party: Simon Chiu, University of Western Ontario London Ontario; Research Scientist, Lawson Health Research Institute London Ontario Canada, Lawson Health Research Institute
• ClinicalTrials.gov Identifier: NCT00401089
• Other Study ID Numbers: R-02-285
• First Posted: November 17, 2006
• Last Update Posted: December 12, 2012
• Last Verified: December 2012

Keywords provided by Simon Chiu, Lawson Health Research Institute:

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

Additional relevant MeSH terms:

Dyskinesias; Tardive Dyskinesia; Insulin Resistance; Schizophrenia; Psychotic Disorders; Signs and Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Dyskinesia, Drug-Induced; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Psychotropic Drugs