Efficacy Study of Panax Ginseng to Boost Antipsychotics Effects in Schizophrenia

NCT00401089 | Completed Phase 1 DMC

• 1 other identifier: R-02-285
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 4

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.

Conditions

Schizophrenia; Schizoaffective Disorder; Tardive Dyskinesia; Insulin Resistance; Obesity

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Neuro-Cognitive Screening Test

  The battery of neurocognitive tests is to be administered in a computerized format to the subjects at various time intervals

  wk 0, 8, crossover , wk 2, 8

• PANSS Positive Negative Syndrome Scale

  Changes in PANSS is the co-primary outcome measure

  -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

  Change from baseline to week 8, cross-over; week 11-week 18.

Secondary Outcomes (7)

• HAM-D Hamilton Depression Rating Scale

  -wk2, wk0, 2, 5, 8 crossover wk 2, 5, 8

• BPRS Brief Psychiatric Rating Scale

  -wk 2, wk 0, 2,5,8 crossover wk 2, 5, 8

• QLS Quality of Life Scale

  wk 0, 8 crossover wk 8

• AIMS Abnormal Involuntary Movement Scale

  -wk 2, wk 0, 2, 5, 8 crossover wk 2, 5, 8

• SAS Simpson Angus Scale for Extrapyramidal Symptoms

  -wk 2, wk 0, 2,5,8 crossover wk 2,5,8

Study Arms (2)

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.

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

Drug: Panax Ginseng

Interventions

Panax Ginseng 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.

Also known as: Ginsana-115

Ginsana-115; Sugar Pill

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• age 18-65 years
• DSM-IV diagnosis of Schizophrenia
• SANS score greater than 30

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Queen's University: collaborator
• Northern Ontario School of Medicine: collaborator
• Imperial College London: collaborator

Study Sites (4)

Queen's University

Kingston, Ontario, Canada

Location

Regional Mental Health Care London

St. Thomas, Ontario, N5P 3V9, Canada

Location

Northern Ontario Medical School

Thunder Bay, Ontario, Canada

Location

Northwick Park Hospital

Harrow, Middlesex, HA13UJ, United Kingdom

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Tardive Dyskinesia; Insulin Resistance; Obesity

Interventions

Asian ginseng

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Dyskinesia, Drug-Induced; Dyskinesias; Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight

Study Officials

• Simon S Chiu, MD PhD

  Lawson Health Research Institute London Ontario Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University of Western Ontario London Ontario; Research Scientist, Lawson Health Research Institute London Ontario Canada

Study Record Dates

• First Submitted: November 15, 2006
• First Posted: November 17, 2006
• Study Start: December 1, 2002
• Primary Completion: December 1, 2006
• Study Completion: October 1, 2007
• Last Updated: December 12, 2012

Record last verified: 2012-12

Locations

GB (1); CA (3)