Extract of Ginkgo Biloba and Tardive Dyskinesia (EGBTD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00672373
Recruitment Status : Completed
First Posted : May 6, 2008
Last Update Posted : May 6, 2008
Peking University
Information provided by:
Beijing HuiLongGuan Hospital

May 2, 2008
May 6, 2008
May 6, 2008
December 2006
May 2007   (Final data collection date for primary outcome measure)
Change in the scores of Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Baseline, 6th and 12th week ]
Same as current
No Changes Posted
  • Change in PANSS [ Time Frame: Baseline, 6th and 12th week ]
  • Change in Simpson-Angus Rating Scales for EPS [ Time Frame: Baseline, 6th and 12th ]
  • Change in cognitive function [ Time Frame: Baseline and 12th week ]
  • Change in Udvalg for Kliniske Undersøgelser (UKU) Side Effect Rating Scale [ Time Frame: Baseline, 6th and 12th week ]
Same as current
Not Provided
Not Provided
Extract of Ginkgo Biloba and Tardive Dyskinesia
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
The purpose of this study is to determine whether Extract of Ginkgo Biloba is effective in the treatment on Tardive dyskinesia
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.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Tardive Dyskinesia
  • Schizophrenia
  • Drug: Extract of Ginkgo Biloba (EGb-761 capsules)
    EGb-761 240mg/d, 1 capsule(80mg) tid,po,12 weeks; Each capsule contains 19.6mg flavonol glycosides and 4.8mg terpene lactones.
    Other Name: YiKangNing
  • Drug: Placebo
    Wheat flour placebo capsule,1 capsule tid, po,12 weeks
  • Experimental: A
    Active treatment with EGb-761 capsules (80mg each capsule), 3 capsules each day for 12 weeks
    Intervention: Drug: Extract of Ginkgo Biloba (EGb-761 capsules)
  • Placebo Comparator: B
    Matching placebo treatment
    Intervention: Drug: Placebo
Zhang WF, Tan YL, Zhang XY, Chan RC, Wu HR, Zhou DF. Extract of Ginkgo biloba treatment for tardive dyskinesia in schizophrenia: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2011 May;72(5):615-21. doi: 10.4088/JCP.09m05125yel. Epub 2010 Sep 21.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
August 2007
May 2007   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Yun Long Tan, Beijing Hui-Long-Guan Hospital
Beijing HuiLongGuan Hospital
Peking University
Principal Investigator: Yunlong Tan, Phd Beijing HuiLongGuan Hospital
Study Chair: Dongfeng Zhou, Professor Institute of mental health, Peking University
Beijing HuiLongGuan Hospital
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP