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Extract of Ginkgo Biloba and Tardive Dyskinesia

NCT ID: NCT00672373

Last Updated: 2008-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Tardive Dyskinesia Schizophrenia

Keywords

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Tardive Dyskinesia Schizophrenia Extract of Gingko Biloba

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Active treatment with EGb-761 capsules (80mg each capsule), 3 capsules each day for 12 weeks

Group Type EXPERIMENTAL

Extract of Ginkgo Biloba (EGb-761 capsules)

Intervention Type DRUG

EGb-761 240mg/d, 1 capsule(80mg) tid,po,12 weeks; Each capsule contains 19.6mg flavonol glycosides and 4.8mg terpene lactones.

B

Matching placebo treatment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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YiKangNing

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University

OTHER

Sponsor Role collaborator

Beijing HuiLongGuan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Beijing Hui-Long-Guan Hospital

Principal Investigators

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Yunlong Tan, Phd

Role: PRINCIPAL_INVESTIGATOR

Beijing HuiLongGuan Hospital

Dongfeng Zhou, Professor

Role: STUDY_CHAIR

Institute of mental health, Peking University

Locations

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Beijing Hui-Long-Guan Hospital

Beijing, , China

Site Status

Countries

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China

References

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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. doi: 10.4088/JCP.09m05125yel. Epub 2010 Sep 21.

Reference Type DERIVED
PMID: 20868638 (View on PubMed)

Other Identifiers

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BJHLG-20061B0501900035

Identifier Type: -

Identifier Source: secondary_id

EGB-ZWF-01

Identifier Type: -

Identifier Source: org_study_id