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Extract of Ginkgo Biloba and Tardive Dyskinesia (EGBTD)

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ClinicalTrials.gov Identifier: NCT00672373
Recruitment Status : Completed
First Posted : May 6, 2008
Last Update Posted : May 6, 2008
Sponsor:
Collaborator:
Peking University
Information provided by:
Beijing HuiLongGuan Hospital

Tracking Information
First Submitted Date  ICMJE May 2, 2008
First Posted Date  ICMJE May 6, 2008
Last Update Posted Date May 6, 2008
Study Start Date  ICMJE December 2006
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2008)
Change in the scores of Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Baseline, 6th and 12th week ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Extract of Ginkgo Biloba and Tardive Dyskinesia
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Tardive Dyskinesia
  • Schizophrenia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 5, 2008)
157
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2007
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00672373
Other Study ID Numbers  ICMJE EGB-ZWF-01
BJHLG-20061B0501900035
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yun Long Tan, Beijing Hui-Long-Guan Hospital
Study Sponsor  ICMJE Beijing HuiLongGuan Hospital
Collaborators  ICMJE Peking University
Investigators  ICMJE
Principal Investigator: Yunlong Tan, Phd Beijing HuiLongGuan Hospital
Study Chair: Dongfeng Zhou, Professor Institute of mental health, Peking University
PRS Account Beijing HuiLongGuan Hospital
Verification Date May 2008

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