Extract of Ginkgo Biloba and Tardive Dyskinesia (EGBTD)
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ClinicalTrials.gov Identifier: NCT00672373 |
Recruitment Status :
Completed
First Posted : May 6, 2008
Last Update Posted : May 6, 2008
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Condition or disease | Intervention/treatment | Phase |
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Tardive Dyskinesia Schizophrenia | Drug: Extract of Ginkgo Biloba (EGb-761 capsules) Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 157 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 Start Date : | December 2006 |
Actual Primary Completion Date : | May 2007 |
Actual Study Completion Date : | August 2007 |

Arm | Intervention/treatment |
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Experimental: A
Active treatment with EGb-761 capsules (80mg each capsule), 3 capsules each day for 12 weeks
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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 |
Placebo Comparator: B
Matching placebo treatment
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Drug: Placebo
Wheat flour placebo capsule,1 capsule tid, po,12 weeks |
- Change in the scores of Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Baseline, 6th and 12th week ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00672373
China | |
Beijing Hui-Long-Guan Hospital | |
Beijing, China, 100096 |
Principal Investigator: | Yunlong Tan, Phd | Beijing HuiLongGuan Hospital | |
Study Chair: | Dongfeng Zhou, Professor | Institute of mental health, Peking University |
Responsible Party: | Yun Long Tan, Beijing Hui-Long-Guan Hospital |
ClinicalTrials.gov Identifier: | NCT00672373 |
Other Study ID Numbers: |
EGB-ZWF-01 BJHLG-20061B0501900035 |
First Posted: | May 6, 2008 Key Record Dates |
Last Update Posted: | May 6, 2008 |
Last Verified: | May 2008 |
Tardive Dyskinesia Schizophrenia Extract of Gingko Biloba |
Dyskinesias Tardive Dyskinesia Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders |
Movement Disorders Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Dyskinesia, Drug-Induced |