Trial record 4 of 38 for:    Tardive Dyskinesia

Extract of Ginkgo Biloba and Tardive Dyskinesia (EGBTD)

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

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

Condition Intervention Phase
Tardive Dyskinesia
Drug: Extract of Ginkgo Biloba (EGb-761 capsules)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Beijing Hui-Long-Guan Hospital:

Primary Outcome Measures:
  • Change in the scores of Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Baseline, 6th and 12th week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 157
Study Start Date: December 2006
Study Completion Date: August 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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
Placebo Comparator: B
Matching placebo treatment
Drug: Placebo
Wheat flour placebo capsule,1 capsule tid, po,12 weeks

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.


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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:

  • 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)
  Contacts and Locations
Please refer to this study by its identifier: NCT00672373

Beijing Hui-Long-Guan Hospital
Beijing, China, 100096
Sponsors and Collaborators
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
  More Information

No publications provided by Beijing Hui-Long-Guan Hospital

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Yun Long Tan, Beijing Hui-Long-Guan Hospital Identifier: NCT00672373     History of Changes
Other Study ID Numbers: EGB-ZWF-01, BJHLG-20061B0501900035
Study First Received: May 2, 2008
Last Updated: May 5, 2008
Health Authority: China: Ethics Committee

Keywords provided by Beijing Hui-Long-Guan Hospital:
Tardive Dyskinesia
Extract of Gingko Biloba

Additional relevant MeSH terms:
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Schizophrenia and Disorders with Psychotic Features
Mental Disorders processed this record on April 22, 2014