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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00672373

Acronym

EGBTD

Enrollment

157

Registered

2008-05-06

Start date

2006-12-31

Completion date

2007-08-31

Last updated

2008-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia, Tardive Dyskinesia

Keywords

Tardive Dyskinesia, Schizophrenia, Extract of Gingko Biloba

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.

Interventions

DRUGExtract 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.

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026