Extract of Ginkgo Biloba and Tardive Dyskinesia

Schizophrenia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00672373
• Other study ID #: EGB-ZWF-01
• Secondary ID: BJHLG-20061B0501
• Status: Completed
• Phase: Phase 3
• First received: May 2, 2008
• Last updated: May 5, 2008
• Start date: December 2006
• Est. completion date: August 2007

Study information

• Verified date: May 2008
• Source: Beijing HuiLongGuan Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether Extract of Ginkgo Biloba is effective in the treatment on Tardive dyskinesia

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: August 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyskinesias
• Schizophrenia
• Tardive Dyskinesia

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

Locations

Country	Name	City	State
China	Beijing Hui-Long-Guan Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing HuiLongGuan Hospital	Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the scores of Abnormal Involuntary Movement Scale (AIMS)		Baseline, 6th and 12th week	No
Secondary	Change in PANSS		Baseline, 6th and 12th week	No
Secondary	Change in Simpson-Angus Rating Scales for EPS		Baseline, 6th and 12th	No
Secondary	Change in cognitive function		Baseline and 12th week	No
Secondary	Change in Udvalg for Kliniske Undersøgelser (UKU) Side Effect Rating Scale		Baseline, 6th and 12th week	Yes