Brief Title
Extract of Ginkgo Biloba and Tardive Dyskinesia
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
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Change in the scores of Abnormal Involuntary Movement Scale (AIMS)
Secondary Outcome
Change in PANSS
Condition
Tardive Dyskinesia
Intervention
Extract of Ginkgo Biloba (EGb-761 capsules)
Study Arms / Comparison Groups
A
Description: Active treatment with EGb-761 capsules (80mg each capsule), 3 capsules each day for 12 weeks
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
157
Start Date
December 2006
Completion Date
August 2007
Primary Completion Date
May 2007
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)
Gender
All
Ages
18 Years - 60 Years
Accepts Healthy Volunteers
No
Contacts
Yunlong Tan, Phd, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT00672373
Organization ID
EGB-ZWF-01
Secondary IDs
BJHLG-20061B0501900035
Study Sponsor
Beijing HuiLongGuan Hospital
Collaborators
Peking University
Study Sponsor
Yunlong Tan, Phd, Principal Investigator, Beijing HuiLongGuan Hospital
Verification Date
May 2008