Extract of Ginkgo Biloba and Tardive Dyskinesia

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Brief Title

Extract of Ginkgo Biloba and Tardive Dyskinesia

Official Title

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

Brief Summary

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

Detailed Description

      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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Change in the scores of Abnormal Involuntary Movement Scale (AIMS)

Secondary Outcome

 Change in PANSS

Condition

Tardive Dyskinesia

Intervention

Extract of Ginkgo Biloba (EGb-761 capsules)

Study Arms / Comparison Groups

 A
Description:  Active treatment with EGb-761 capsules (80mg each capsule), 3 capsules each day for 12 weeks

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

157

Start Date

December 2006

Completion Date

August 2007

Primary Completion Date

May 2007

Eligibility Criteria

        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)
      

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Yunlong Tan, Phd, , 

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT00672373

Organization ID

EGB-ZWF-01

Secondary IDs

BJHLG-20061B0501900035


Study Sponsor

Beijing HuiLongGuan Hospital

Collaborators

 Peking University

Study Sponsor

Yunlong Tan, Phd, Principal Investigator, Beijing HuiLongGuan Hospital


Verification Date

May 2008