Extract of Ginkgo Biloba and Tardive Dyskinesia (EGBTD)
Primary Purpose
Tardive Dyskinesia, Schizophrenia
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Extract of Ginkgo Biloba (EGb-761 capsules)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Tardive Dyskinesia focused on measuring Tardive Dyskinesia, Schizophrenia, Extract of Gingko Biloba
Eligibility 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)
Sites / Locations
- Beijing Hui-Long-Guan Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
A
B
Arm Description
Active treatment with EGb-761 capsules (80mg each capsule), 3 capsules each day for 12 weeks
Matching placebo treatment
Outcomes
Primary Outcome Measures
Change in the scores of Abnormal Involuntary Movement Scale (AIMS)
Secondary Outcome Measures
Change in PANSS
Change in Simpson-Angus Rating Scales for EPS
Change in cognitive function
Change in Udvalg for Kliniske Undersøgelser (UKU) Side Effect Rating Scale
Full Information
NCT ID
NCT00672373
First Posted
May 2, 2008
Last Updated
May 5, 2008
Sponsor
Beijing HuiLongGuan Hospital
Collaborators
Peking University
1. Study Identification
Unique Protocol Identification Number
NCT00672373
Brief Title
Extract of Ginkgo Biloba and Tardive Dyskinesia
Acronym
EGBTD
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 Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Beijing HuiLongGuan Hospital
Collaborators
Peking University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tardive Dyskinesia, Schizophrenia
Keywords
Tardive Dyskinesia, Schizophrenia, Extract of Gingko Biloba
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
157 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Active treatment with EGb-761 capsules (80mg each capsule), 3 capsules each day for 12 weeks
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Matching placebo treatment
Intervention Type
Drug
Intervention Name(s)
Extract of Ginkgo Biloba (EGb-761 capsules)
Other Intervention Name(s)
YiKangNing
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Wheat flour placebo capsule,1 capsule tid, po,12 weeks
Primary Outcome Measure Information:
Title
Change in the scores of Abnormal Involuntary Movement Scale (AIMS)
Time Frame
Baseline, 6th and 12th week
Secondary Outcome Measure Information:
Title
Change in PANSS
Time Frame
Baseline, 6th and 12th week
Title
Change in Simpson-Angus Rating Scales for EPS
Time Frame
Baseline, 6th and 12th
Title
Change in cognitive function
Time Frame
Baseline and 12th week
Title
Change in Udvalg for Kliniske Undersøgelser (UKU) Side Effect Rating Scale
Time Frame
Baseline, 6th and 12th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunlong Tan, Phd
Organizational Affiliation
Beijing HuiLongGuan Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dongfeng Zhou, Professor
Organizational Affiliation
Institute of mental health, Peking University
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Hui-Long-Guan Hospital
City
Beijing
ZIP/Postal Code
100096
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
20868638
Citation
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.
Results Reference
derived
Learn more about this trial
Extract of Ginkgo Biloba and Tardive Dyskinesia
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