Extract of Ginkgo Biloba and Tardive Dyskinesia - Full Text View

Sponsors and Collaborators:	Beijing Hui-Long-Guan Hospital Peking University
Information provided by:	Beijing Hui-Long-Guan Hospital
ClinicalTrials.gov Identifier:	NCT00672373

Purpose

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 Schizophrenia	Drug: Extract of Ginkgo Biloba (EGb-761 capsules) Drug: Placebo	Phase III

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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

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
A: Experimental 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.
B: Placebo Comparator 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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 ClinicalTrials.gov identifier: NCT00672373

Locations

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

Sponsors and Collaborators

Beijing Hui-Long-Guan Hospital

Peking University

Investigators

Principal Investigator:	Yunlong Tan, Phd	Beijing Hui-Long-Guan Hospital
Study Chair:	Dongfeng Zhou, Professor	Institute of mental health, Peking University

More Information

Responsible Party:	Beijing Hui-Long-Guan Hospital ( Yun Long Tan )
Study ID Numbers:	EGB-ZWF-01, BJHLG-20061B0501900035
Study First Received:	May 2, 2008
Last Updated:	May 5, 2008
ClinicalTrials.gov Identifier:	NCT00672373
Health Authority:	China: Ethics Committee

Keywords provided by Beijing Hui-Long-Guan Hospital:

Tardive Dyskinesia
Schizophrenia
Extract of Gingko Biloba

Study placed in the following topic categories:

Schizophrenia
Signs and Symptoms
Cardiac Glycosides
Mental Disorders
Movement Disorders
Neurologic Manifestations

Central Nervous System Diseases
Psychotic Disorders
Dyskinesias
Tardive dyskinesia
Schizophrenia and Disorders with Psychotic Features
Oral facial dyskinesia

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009