Text Size

Extract of Ginkgo Biloba and Tardive Dyskinesia (EGBTD)

This study has been completed.
Sponsor:
Collaborator:
Peking University
Information provided by:
Beijing Hui-Long-Guan Hospital
ClinicalTrials.gov Identifier:
NCT00672373
First received: May 2, 2008
Last updated: May 5, 2008
Last verified: May 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Tardive Dyskinesia
Schizophrenia
 Drug: Extract of Ginkgo Biloba (EGb-761 capsules)
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by Beijing Hui-Long-Guan Hospital:

Primary Outcome Measures:
  • Change in the scores of Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Baseline, 6th and 12th week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in PANSS [ Time Frame: Baseline, 6th and 12th week ] [ Designated as safety issue: No ]
  • Change in Simpson-Angus Rating Scales for EPS [ Time Frame: Baseline, 6th and 12th ] [ Designated as safety issue: No ]
  • Change in cognitive function [ Time Frame: Baseline and 12th week ] [ Designated as safety issue: No ]
  • Change in Udvalg for Kliniske Undersøgelser (UKU) Side Effect Rating Scale [ Time Frame: Baseline, 6th and 12th week ] [ Designated as safety issue: Yes ]

Enrollment: 157
Study Start Date: December 2006
Study Completion Date: August 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Active treatment with EGb-761 capsules (80mg each capsule), 3 capsules each day for 12 weeks
 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
 Drug: Placebo
Wheat flour placebo capsule,1 capsule tid, po,12 weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00672373

Locations
China
Beijing Hui-Long-Guan Hospital
Beijing, China, 100096
Sponsors and Collaborators
Beijing Hui-Long-Guan Hospital
Peking University
Investigators
Principal Investigator: Yunlong Tan, Phd Beijing Hui-Long-Guan Hospital
Study Chair: Dongfeng Zhou, Professor Institute of mental health, Peking University
  More Information

No publications provided by Beijing Hui-Long-Guan Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Yun Long Tan, Beijing Hui-Long-Guan Hospital
ClinicalTrials.gov Identifier: NCT00672373     History of Changes
Other Study ID Numbers: EGB-ZWF-01, BJHLG-20061B0501900035
Study First Received: May 2, 2008
Last Updated: May 5, 2008
Health Authority: China: Ethics Committee

Keywords provided by Beijing Hui-Long-Guan Hospital:
Tardive Dyskinesia
Schizophrenia
Extract of Gingko Biloba

Additional relevant MeSH terms:
Dyskinesias
Schizophrenia
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
 Neurologic Manifestations
Signs and Symptoms
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on June 17, 2013