Extract of Ginkgo Biloba and Tardive Dyskinesia

Phase 3

Completed

• Conditions: Tardive Dyskinesia; Schizophrenia
• Interventions: Drug: Extract of Ginkgo Biloba (EGb-761 capsules); Drug: Placebo

• Registration Number: NCT00672373
• Lead Sponsor: Beijing HuiLongGuan Hospital

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 Timeline

• Study Start: 2006-12
• Primary Completion: 2007-05
• Study Completion: 2007-08
• Status Verified: 2008-05
• Study First Submitted: 2008-05-02
• Study First Submitted QC: 2008-05-05
• Last Update Submitted: 2008-05-05
• Study First Posted: 2008-05-06
• Last Update Posted: 2008-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in the scores of Abnormal Involuntary Movement Scale (AIMS)	Baseline, 6th and 12th week

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Beijing Hui-Long-Guan Hospital; 🇨🇳 Beijing, China