Clinical trial NCT00401089: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Schizophrenia
Schizoaffective Disorder
Tardive Dyskinesia
Insulin Resistance
Obesity
Keywords: negative symptoms schizophrenia
Atypical antipsychotics
Neurocognition impairment
obesity risk factor
Diabetes insulin resistance schizophrenia
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Queen's University
name: Northern Ontario School of Medicine
name: Imperial College London
First posted: 2006-11-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Neuro-Cognitive Screening Test
timeFrame: wk 0, 8, crossover , wk 2, 8
measure: PANSS Positive Negative Syndrome Scale
timeFrame: -wk 2, wk 0, 2, 5,8 crossover wk 2,5,8
measure: SANS
timeFrame: Change from baseline to week 8, cross-over; week 11-week 18.
Secondary outcomes:
measure: HAM-D Hamilton Depression Rating Scale
timeFrame: -wk2, wk0, 2, 5, 8 crossover wk 2, 5, 8
measure: BPRS Brief Psychiatric Rating Scale
timeFrame: -wk 2, wk 0, 2,5,8 crossover wk 2, 5, 8
measure: QLS Quality of Life Scale
timeFrame: wk 0, 8 crossover wk 8
measure: AIMS Abnormal Involuntary Movement Scale
timeFrame: -wk 2, wk 0, 2, 5, 8 crossover wk 2, 5, 8
measure: SAS Simpson Angus Scale for Extrapyramidal Symptoms
timeFrame: -wk 2, wk 0, 2,5,8 crossover wk 2,5,8
measure: Blood Chemistry Profile: CBC, kidney function,lipid profile, fasting glucose insulin
timeFrame: -wk 2, wk 8 crossover wk 8
measure: BMI Body Mass index
timeFrame: Change from baseline to end of 18-week period
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
city: St. Thomas
country: Canada
facility: Regional Mental Health Care London
state: Ontario
city: Thunder Bay
country: Canada
facility: Northern Ontario Medical School
state: Ontario
city: Harrow
country: United Kingdom
facility: Northwick Park Hospital
state: Middlesex
Study officials:
affiliation: Lawson Health Research Institute London Ontario Canada
name: Simon S Chiu, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: