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Extract of Ginkgo Biloba and Tardive Dyskinesia (EGBTD)

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ClinicalTrials.gov Identifier: NCT00672373
Recruitment Status : Completed
First Posted : May 6, 2008
Last Update Posted : May 6, 2008
Sponsor:
Collaborator:
Peking University
Information provided by:
Beijing HuiLongGuan Hospital

Study Description
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Brief Summary:
The purpose of this study is to determine whether Extract of Ginkgo Biloba is effective in the treatment on Tardive dyskinesia

Condition or disease Intervention/treatment Phase
Tardive Dyskinesia Schizophrenia Drug: Extract of Ginkgo Biloba (EGb-761 capsules) Drug: Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 157 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : December 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: YiKangNing
Placebo Comparator: B
Matching placebo treatment
 Drug: Placebo
Wheat flour placebo capsule,1 capsule tid, po,12 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Change in the scores of Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Baseline, 6th and 12th week ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00672373


Locations
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China
Beijing Hui-Long-Guan Hospital
Beijing, China, 100096
Sponsors and Collaborators
Beijing HuiLongGuan Hospital
Peking University
Investigators
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Principal Investigator: Yunlong Tan, Phd Beijing HuiLongGuan Hospital
Study Chair: Dongfeng Zhou, Professor Institute of mental health, Peking University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yun Long Tan, Beijing Hui-Long-Guan Hospital
ClinicalTrials.gov Identifier: NCT00672373    
Other Study ID Numbers: EGB-ZWF-01
BJHLG-20061B0501900035
First Posted: May 6, 2008    Key Record Dates
Last Update Posted: May 6, 2008
Last Verified: May 2008
Keywords provided by Beijing HuiLongGuan Hospital:
Tardive Dyskinesia
Schizophrenia
Extract of Gingko Biloba
Additional relevant MeSH terms:
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Dyskinesias
Tardive Dyskinesia
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
 Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Dyskinesia, Drug-Induced