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CompletedNCT00672373EGBTDUpdated May 6, 2008

Extract of Ginkgo Biloba and Tardive Dyskinesia

A Phase 3 interventional study of Extract of Ginkgo Biloba (EGb-761 capsules) and Placebo in Tardive Dyskinesia and Schizophrenia, sponsored by Beijing HuiLongGuan Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2008-05-06.

Sponsored by Beijing HuiLongGuan Hospital · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
157
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Tardive Dyskinesia
  • Schizophrenia

Keywords

  • Tardive Dyskinesia
  • Schizophrenia
  • Extract of Gingko Biloba
03

In context

Dyskinesias

270 studies on the registry are indexed under Dyskinesias; 41 are open to participants now.

This study's enrollment of 157 is above the median of 44 across 192 interventional studies indexed under Dyskinesias.

Browse Dyskinesias studies →

Lead sponsor

Beijing HuiLongGuan Hospital is the lead sponsor of 21 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
157 participants (actual)

Study arms

  • Experimental
    A

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

    Drug: Extract of Ginkgo Biloba (EGb-761 capsules)

  • Placebo comparator
    B

    Matching placebo treatment

    Drug: Placebo

Interventions

  • DrugExtract 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.

    Also known as: YiKangNing

  • DrugPlacebo

    Wheat flour placebo capsule,1 capsule tid, po,12 weeks

06

What researchers measure

Primary outcomes

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

    Time frame: Baseline, 6th and 12th week

Secondary outcomes

  1. Change in PANSS

    Time frame: Baseline, 6th and 12th week

  2. Change in Simpson-Angus Rating Scales for EPS

    Time frame: Baseline, 6th and 12th

  3. Change in cognitive function

    Time frame: Baseline and 12th week

  4. Change in Udvalg for Kliniske Undersøgelser (UKU) Side Effect Rating Scale

    Time frame: Baseline, 6th and 12th week

07

Study locations

1 site
  • Beijing Hui-Long-Guan Hospital
    Beijing, 100096, China
08

References and documents

Publications

  • 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. PubMed 20868638 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00672373
Lead sponsor
Beijing HuiLongGuan Hospital
Collaborators
Peking University
First posted
May 6, 2008
Start date
Dec 2006
Primary completion
May 2007
Completion
Aug 2007
Last update
May 6, 2008

Study contacts

Yunlong Tan, Phd
principal investigator · Beijing HuiLongGuan Hospital
Dongfeng Zhou, Professor
study chair · Institute of mental health, Peking University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.

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