Extract of Ginkgo Biloba and Tardive Dyskinesia (EGBTD)

May 5, 2008 updated by: Beijing HuiLongGuan Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

157

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100096
        • Beijing Hui-Long-Guan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • YiKangNing
Placebo Comparator: B
Matching placebo treatment
Drug: Placebo
Wheat flour placebo capsule,1 capsule tid, po,12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the scores of Abnormal Involuntary Movement Scale (AIMS)
Time Frame: Baseline, 6th and 12th week
Baseline, 6th and 12th week

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in PANSS
Time Frame: Baseline, 6th and 12th week
Baseline, 6th and 12th week
Change in Simpson-Angus Rating Scales for EPS
Time Frame: Baseline, 6th and 12th
Baseline, 6th and 12th
Change in cognitive function
Time Frame: Baseline and 12th week
Baseline and 12th week
Change in Udvalg for Kliniske Undersøgelser (UKU) Side Effect Rating Scale
Time Frame: Baseline, 6th and 12th week
Baseline, 6th and 12th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing HuiLongGuan Hospital

Collaborators

Peking University

Investigators

  • Principal Investigator: Yunlong Tan, Phd, Beijing HuiLongGuan Hospital
  • Study Chair: Dongfeng Zhou, Professor, Institute of Mental Health, Peking University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

May 2, 2008

First Submitted That Met QC Criteria

May 5, 2008

First Posted (Estimate)

May 6, 2008

Study Record Updates

Last Update Posted (Estimate)

May 6, 2008

Last Update Submitted That Met QC Criteria

May 5, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EGB-ZWF-01
  • BJHLG-20061B0501900035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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