Extract of Ginkgo Biloba and Tardive Dyskinesia (EGBTD)

This study has been completed.
Sponsor:
Collaborator:
Peking University
Information provided by:
Beijing Hui-Long-Guan Hospital
ClinicalTrials.gov Identifier:
NCT00672373
First received: May 2, 2008
Last updated: May 5, 2008
Last verified: May 2008

May 2, 2008
May 5, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00672373 on ClinicalTrials.gov Archive Site
  • Change in PANSS [ Time Frame: Baseline, 6th and 12th week ] [ Designated as safety issue: No ]
  • Change in Simpson-Angus Rating Scales for EPS [ Time Frame: Baseline, 6th and 12th ] [ Designated as safety issue: No ]
  • Change in cognitive function [ Time Frame: Baseline and 12th week ] [ Designated as safety issue: No ]
  • Change in Udvalg for Kliniske Undersøgelser (UKU) Side Effect Rating Scale [ Time Frame: Baseline, 6th and 12th week ] [ Designated as safety issue: Yes ]
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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. Epub 2010 Sep 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
157
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)
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00672373
EGB-ZWF-01, BJHLG-20061B0501900035
Yes
Yun Long Tan, Beijing Hui-Long-Guan Hospital
Beijing Hui-Long-Guan Hospital
Peking University
Principal Investigator: Yunlong Tan, Phd Beijing Hui-Long-Guan Hospital
Study Chair: Dongfeng Zhou, Professor Institute of mental health, Peking University
Beijing Hui-Long-Guan Hospital
May 2008

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