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Completed

NCT Number: NCT00672373

Extract of Ginkgo Biloba and Tardive Dyskinesia

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

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Key information

Conditions

Tardive Dyskinesia Central Nervous System Diseases Dyskinesia, Drug-Induced Dyskinesias Mental Disorders Movement Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Hui-Long-Guan Hospital

Beijing, 100096, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Extract of Ginkgo Biloba (EGb-761 capsules)

Drug

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

Drug

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

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

Sponsors and collaborators

Lead sponsor

Beijing HuiLongGuan Hospital

Other

Collaborators

  • Peking University

Registry information

Official study 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

Acronym: EGBTD

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
May 6, 2008
Registry last updated
May 6, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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