Extract of Ginkgo Biloba and Tardive Dyskinesia

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Extract of Ginkgo Biloba is effective in the treatment on Tardive dyskinesia

Detailed Description
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Tardive dyskinesia(TD) is a common complication of conventional antipsychotic treatment in subjects with schizophrenia. There is no established treatment for TD patients.This disorder remains a significant clinical problem for both patients and physicians for the foreseeable future.

Official Title
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A Double-Blind, Randomised, Parallel-Group Comparison of Extract of Ginkgo Biloba(EGB-761) Versus Placebo as Add-on Medication in Patients With Established Tardive Dyskinesia

Conditions
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Tardive Dyskinesia, Schizophrenia

Intervention / Treatment
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* Drug: Extract of Ginkgo Biloba (EGb-761 capsules)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged 18 to 60yrs Meeting Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition(DSM-IV) criteria for schizophrenia or schizo-affective disorder Abnormal Involuntary Movement Scale (AIMS) score ≥2. Patients from whom informed, written consent is obtained. Patients who have been on a fixed dose of antipsychotic medication for at least 4 weeks prior to trial entry. Exclusion Criteria: Significant neurological disorder other than TD Substance abuse Significant other medical illness Psychiatric disorder not stabilised Pregnancy or lactation Take antioxidants(such as Vitamin C)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Active treatment with EGb-761 capsules (80mg each capsule), 3 capsules each day for 12 weeks | Drug: Extract of Ginkgo Biloba (EGb-761 capsules)<br>* EGb-761 240mg/d, 1 capsule(80mg) tid,po,12 weeks; Each capsule contains 19.6mg flavonol glycosides and 4.8mg terpene lactones.<br>* Other names: YiKangNing;|
| Placebo Comparator: B<br>Matching placebo treatment | Drug: Placebo<br>* Wheat flour placebo capsule,1 capsule tid, po,12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the scores of Abnormal Involuntary Movement Scale (AIMS) |  | Baseline, 6th and 12th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PANSS |  | Baseline, 6th and 12th week | 
| Change in Simpson-Angus Rating Scales for EPS |  | Baseline, 6th and 12th | 
| Change in cognitive function |  | Baseline and 12th week | 
| Change in Udvalg for Kliniske Undersøgelser (UKU) Side Effect Rating Scale |  | Baseline, 6th and 12th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tardive Dyskinesia, Schizophrenia, Extract of Gingko Biloba