Extract of Ginkgo Biloba and Tardive Dyskinesia (EGBTD)

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

Tracking Information

• First Submitted Date: May 2, 2008
• First Posted Date: May 6, 2008
• Last Update Posted Date: May 6, 2008
• Study Start Date: December 2006
• Actual Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 5, 2008): Change in the scores of Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Baseline, 6th and 12th week ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: May 5, 2008)

• Change in PANSS [ Time Frame: Baseline, 6th and 12th week ]
• Change in Simpson-Angus Rating Scales for EPS [ Time Frame: Baseline, 6th and 12th ]
• Change in cognitive function [ Time Frame: Baseline and 12th week ]
• Change in Udvalg for Kliniske Undersøgelser (UKU) Side Effect Rating Scale [ Time Frame: Baseline, 6th and 12th week ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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 Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Tardive Dyskinesia
• Schizophrenia

Intervention

• 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
• Drug: Placebo
  Wheat flour placebo capsule,1 capsule tid, po,12 weeks

Study Arms

• Experimental: A
  Active treatment with EGb-761 capsules (80mg each capsule), 3 capsules each day for 12 weeks
  Intervention: Drug: Extract of Ginkgo Biloba (EGb-761 capsules)
• Placebo Comparator: B
  Matching placebo treatment
  Intervention: Drug: Placebo

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 5, 2008): 157
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: August 2007
• Actual Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT00672373
• Other Study ID Numbers: EGB-ZWF-01; BJHLG-20061B0501900035
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Yun Long Tan, Beijing Hui-Long-Guan Hospital
• Study Sponsor: Beijing HuiLongGuan Hospital
• Collaborators: Peking University

Investigators

• Principal Investigator: Yunlong Tan, Phd; Beijing HuiLongGuan Hospital
• Study Chair: Dongfeng Zhou, Professor; Institute of mental health, Peking University

• PRS Account: Beijing HuiLongGuan Hospital
• Verification Date: May 2008